The Congressional Record is a unique source of public documentation. It started in 1873, documenting nearly all the major and minor policies being discussed and debated.
“TEXT OF AMENDMENTS” mentioning the Federal Reserve System was published in the Senate section on pages S5661-S5668 on May 7, 2007.
The publication is reproduced in full below:
TEXT OF AMENDMENTS
SA 1045. Mr. REID (for Mr. Obama) submitted an amendment intended to be proposed by Mr. Reid to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. __. IMPROVING GENETIC TEST SAFETY AND QUALITY.
Not later than 30 days after the date of enactment of this Act, the Secretary shall enter into a contract with the Institute of Medicine to conduct a study to assess the overall safety and quality of genetic tests and prepare a report that includes recommendations to improve Federal oversight and regulation of genetic tests. Such study shall take into consideration relevant reports by the Secretary's Advisory Committee on Genetic Testing and other groups and shall be completed not later than 1 year after the date on which the Secretary entered into such contract.
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SA 1046. Ms. STABENOW (for herself, Mr. Kohl, Mr. Hatch, and Mr. Coburn) submitted an amendment intended to be proposed by her to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. __. CITIZENS PETITIONS AND PETITIONS FOR STAY OF AGENCY
ACTION.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by this Act, is amended by adding at the end the following:
``(s) Citizen Petitions and Petitions for Stay of Agency Action.--
``(1) In general.--
``(A) No delay of consideration or approval.--
``(i) In general.--With respect to a pending application submitted under subsection (b)(2) or (j), if a petition is submitted to the Secretary that seeks to have the Secretary take, or refrain from taking, any form of action relating to the approval of the application, including a delay in the effective date of the application, clauses (ii) and (iii) shall apply.
``(ii) No delay of consideration or approval.--Except as provided in clause (iii), the receipt and consideration of a petition described in clause (i) shall not delay consideration or approval of an application submitted under subsection (b)(2) or (j).
``(iii) No delay of approval without determination.--The Secretary shall not delay approval of an application submitted under subsection (b)(2) or (j) while a petition described in clause (i) is reviewed and considered unless the Secretary determines, not later than 25 business days after the submission of the petition, that a delay is necessary to protect the public health.
``(B) Determination of delay.--With respect to a determination by the Secretary under subparagraph (A)(iii) that a delay is necessary to protect the public health the following shall apply:
``(i) Not later than 5 days after making such determination, the Secretary shall publish on the Internet website of the Food and Drug Administration a detailed statement providing the reasons underlying the determination. The detailed statement shall include a summary of the petition and comments and supplements, the specific substantive issues that the petition raises which need to be considered prior to approving a pending application submitted under subsection (b)(2) or (j), and any clarifications and additional data that is needed by the Secretary to promptly review the petition.
``(ii) Not later than 10 days after making such determination, the Secretary shall provide notice to the sponsor of the pending application submitted under subsection
(b)(2) or (j) and provide an opportunity for a meeting with appropriate staff as determined by the Commissioner to discuss the determination.
``(2) Timing of final agency action on petitions.--
``(A) In general.--Notwithstanding a determination made by the Secretary under paragraph (1)(A)(iii), the Secretary shall take final agency action with respect to a petition not later than 180 days of submission of that petition unless the Secretary determines, prior to the date that is 180 days after the date of submission of the petition, that a delay is necessary to protect the public health.
``(B) Determination of delay.--With respect to a determination by the Secretary under subparagraph (A) that a delay is necessary to protect the public health the following shall apply:
``(i) Not later than 5 days after making the determination under subparagraph (A), the Secretary shall publish on the Internet website of the Food and Drug Administration a detailed statement providing the reasons underlying the determination. The detailed statement should include the state of the review of the petition, the specific outstanding issues that still need to be resolved, a proposed timeframe to resolve the issues, and any additional information that has been requested by the Secretary of the petitioner or needed by the Secretary in order to resolve the petition and not further delay an application filed under subsection
(b)(2) or (j).
``(ii) Not later than 10 days after making the determination under subparagraph (A), the Secretary shall provide notice to the sponsor of the pending application submitted under subsection (b)(2) or (j) and provide an opportunity for a meeting with appropriate staff as determined by the Commissioner to discuss the determination.
``(3) Verifications.--
``(A) Petitions for review.--The Secretary shall not accept a petition for review unless it is signed and contains the following verification: `I certify that, to my best knowledge and belief: (a) this petition includes all information and views upon which the petition relies; (b) this petition includes representative data and/or information known to the petitioner which are unfavorable to the petition; and (c) information upon which I have based the action requested herein first became known to the party on whose behalf this petition is filed on or about __________. I received or expect to receive payments, including cash and other forms of consideration, from the following persons or organizations to file this petition: ________. I verify under penalty of perjury that the foregoing is true and correct.', with the date of the filing of such petition and the signature of the petitioner inserted in the first and second blank space, respectively.
``(B) Supplemental information.--The Secretary shall not accept for review any supplemental information or comments on a petition unless the party submitting such information or comments does so in written form and that the subject document is signed and contains the following verification:
`I certify that, to my best knowledge and belief: (a) I have not intentionally delayed submission of this document or its contents; and (b) the information upon which I have based the action requested herein first became known to me on or about __________. I received or expect to receive payments, including cash and other forms of consideration, from the following persons or organizations to submit this information or its contents: _____. I verify under penalty of perjury that the foregoing is true and correct.', with the date of the submission of such document and the signature of the petitioner inserted in the first and second blank space, respectively.
``(4) Annual report on delays in approvals per petition.--The Secretary shall annually submit to the Congress a report that specifies--
``(A) the number of applications under subsection (b)(2) and (j) that were approved during the preceding 1-year period;
``(B) the number of petitions that were submitted during such period;
``(C) the number of applications whose effective dates were delayed by petitions during such period and the number of days by which the applications were so delayed; and
``(D) the number of petitions that were filed under this subsection that were deemed by the Secretary under paragraph
(1)(A)(iii) to require delaying an application under subsection (b)(2) or (j) and the number of days by which the applications were so delayed.
``(5) Exception.--This subsection does not apply to a petition that is made by the sponsor of the application under subsection (b)(2) or (j) and that seeks only to have the Secretary take or refrain from taking any form of action with respect to that application.
``(6) Report by inspector general.--The Office of Inspector General of the Department of Health and Human Services shall issue a report not later than 2 years after the date of enactment of this subsection evaluating evidence of the compliance of the Food and Drug Administration with the requirement that the consideration by the Secretary of petitions that do not raise public health concerns remain separate and apart from the review and approval of an application submitted under subsection (b)(2) or (j).
``(7) Definition.--For purposes of this subsection, the term `petition' includes any request for an action described in paragraph (1)(A)(i) to the Secretary, without regard to whether the request is characterized as a petition.''.
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SA 1047. Mr. ROBERTS (for himself, Mr. Harkin, Mr. Burr, and Mr. Coburn) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
Strike subparagraphs (E) and (F) of section 505(o)(5) of the Federal Food, Drug, and Cosmetic Act, as added by this Act, and insert the following:
``(E) Specific disclosures.--
``(i) Serious risk; safety protocol.--If the Secretary determines that advertisements lacking a specific disclosure about a serious risk listed in the labeling of a drug or about a protocol to ensure safe use described in the labeling of the drug would be false or misleading, the risk evaluation and mitigation strategy for the drug may require that the applicant include in advertisements of the drug such disclosure.
``(ii) Date of approval.--If the Secretary determines that advertisements lacking a specific disclosure of the date a drug was approved and disclosure of a serious risk would be false or misleading, the risk evaluation and mitigation strategy for the drug may require that the applicant include in advertisements of the drug such disclosure.
``(iii) Specification of advertisements.--The Secretary may specify the advertisements required to include a specific disclosure under clause (i) or (ii).
``(iv) Required safety surveillance.--If the approved risk evaluation and mitigation strategy for a drug requires the specific disclosure under clause (ii), the Secretary shall--
``(I) consider identifying and assessing all serious risks of using the drug to be a priority safety question under subsection (k)(3)(B);
``(II) not less frequently than every 3 months, evaluate the reports under subsection (k)(1) and the routine active surveillance as available under subsection (k)(3) with respect to such priority drug safety question to determine whether serious risks that might occur among patients expected to be treated with the drug have been adequately identified and assessed;
``(III) remove such specific disclosure requirement as an element of such strategy if such serious risks have been adequately identified and assessed; and
``(IV) consider whether a specific disclosure under clause
(i) should be required.
On page 101, strike lines 7 through 9.
At the end of the bill, add the following:
SEC. __. CIVIL PENALTIES; DIRECT-TO-CONSUMER ADVERTISEMENT.
(a) Civil Penalties.--Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the following:
``(g)(1) Any applicant (as such term is used in section 505(o)) who disseminates a direct-to-consumer advertisement for a prescription drug that is false or misleading and a violation of section 502(n) shall be liable to the United States for a civil penalty in an amount not to exceed
$150,000 for the first such violation in any 3-year period, and not to exceed $300,000 for each subsequent violation committed after the applicant has been penalized under this paragraph any time in the preceding 3-year period. For the purposes of this paragraph, repeated dissemination of the same or similar advertisement prior to the receipt of the written notice referred to in paragraph (2) for such advertisements shall be considered as 1 violation.
``(2) A civil penalty under paragraph (1) shall be assessed by the Secretary by an order made on the record after providing written notice to the applicant to be assessed a civil penalty and an opportunity for a hearing in accordance with this paragraph and section 554 of title 5, United States Code. If upon receipt of the written notice, the applicant to be assessed a civil penalty objects and requests a hearing, then in the course of any investigation related to such hearing, the Secretary may issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation, including information pertaining to the factors described in paragraph (3).
``(3) Upon the request of the applicant to be assessed a civil penalty, the Secretary, in determining the amount of a civil penalty, shall take into account the nature, circumstances, extent, and gravity of the violation or violations, including the following factors:
``(A) Whether the applicant submitted the advertisement or a similar advertisement for review under section 736A.
``(B) Whether the applicant submitted the advertisement for prereview if required under section 505(o)(5)(D).
``(C) Whether, after submission of the advertisement as described in subparagraph (A) or (B), the applicant disseminated the advertisement before the end of the 45-day comment period.
``(D) Whether the applicant failed to incorporate any comments made by the Secretary with regard to the advertisement or a similar advertisement into the advertisement prior to its dissemination.
``(E) Whether the applicant ceased distribution of the advertisement upon receipt of the written notice referred to in paragraph (2) for such advertisement.
``(F) Whether the applicant had the advertisement reviewed by qualified medical, regulatory, and legal reviewers prior to its dissemination.
``(G) Whether the violations were material.
``(H) Whether the applicant who created the advertisement acted in good faith.
``(I) Whether the applicant who created the advertisement has been assessed a civil penalty under this provision within the previous 1-year period.
``(J) The scope and extent of any voluntary, subsequent remedial action by the applicant.
``(K) Such other matters, as justice may require.
``(4)(A) Subject to subparagraph (B), no applicant shall be required to pay a civil penalty under paragraph (1) if the applicant submitted the advertisement to the Secretary and disseminated such advertisement after incorporating any comment received from the Secretary.
``(B) The Secretary may retract or modify any prior comments the Secretary has provided to an advertisement submitted to the Secretary based on new information or changed circumstances, so long as the Secretary provides written notice to the applicant of the new views of the Secretary on the advertisement and provides a reasonable time for modification or correction of the advertisement prior to seeking any civil penalty under paragraph (1).
``(5) The Secretary may compromise, modify, remit, with or without conditions, any civil penalty which may be assessed under paragraph (1). The amount of such penalty, when finally determined, or the amount charged upon in compromise, may be deducted from any sums owned by the United States to the applicant charged.
``(6) Any applicant who requested, in accordance with paragraph (2), a hearing with respect to the assessment of a civil penalty and who is aggrieved by an order assessing a civil penalty, may file a petition for de novo judicial review of such order with the United States Court of Appeals for the District of Columbia Circuit or for any other circuit in which such applicant resides or transacts business. Such a petition may only be filed within the 60-day period beginning on the date the order making such assessments was issued.
``(7) If any applicant fails to pay an assessment of a civil penalty--
``(A) after the order making the assessment becomes final, and if such applicant does not file a petition for judicial review of the order in accordance with paragraph (6); or
``(B) after a court in an action brought under paragraph
(6) has entered a final judgment in favor of the Secretary,the Attorney General shall recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of the 60-day period referred to in paragraph (6) or date of such final judgment, as the case may be) in an action brought in any appropriate district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty shall not be subject to review.''.
(b) Direct-to-Consumer Advertisement.--
(1) In general.--Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended by inserting after the first sentence the following: ``In the case of an advertisement for a prescription drug presented directly to consumers in television or radio format that states the name of the drug and its conditions of use, the major statement relating to side effects, contraindications, and effectiveness referred to in the previous sentence shall be stated in a clear and conspicuous (neutral) manner.''.
(2) Regulations to determine neutral manner.--The Secretary of Health and Human Services shall by regulation establish standards for determining whether a major statement, relating to side effects, contraindications, and effectiveness of a drug, described in section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) (as amended by paragraph
(1)) is presented in the manner required under such section.
______
SA 1048. Ms. SNOWE submitted an amendment intended to be proposed by her to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. __. MARKETING OF CERTAIN CRUSTACEANS.
(a) In General.--Notwithstanding any other provision of law, for purposes of the Federal Food, Drug, and, Costmetic Act (21 U.S.C. 301 et seq.) the term ``lobster'' may not be used to label or advertise the sale of any seafood product from the infraorder Garidea or Anomura.
(b) Misbranded Food.--Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the following:
(y) Lobster.--If it purports to be, or is represented as being, lobster but is from the infraorder Caridea or Anomura.''.
______
SA 1049. Mr. ENZI (for himself and Mr. Kennedy) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
Beginning on page 104, strike line 23 and all that follows through line 14 on page 105 and insert the following:
``(II) the amount equal to one-fifth of the excess amount in item (bb), provided that--
``(aa) the amount of the total appropriation for the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of the total appropriation for the Food and Drug Administration for fiscal year 2007 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided under subsection (c)(1); and
``(bb) the amount of the total appropriations for the process of human drug review at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of appropriations for the process of human drug review at the Food and Drug Administration for fiscal year 2007 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided under subsection (c)(1).
In making the adjustment under subclause (II) for any fiscal year 2008 through 2012, subsection (c)(1) shall be applied by substituting `2007' for `2008.' ''.
______
SA 1050. Mr. ENZI (for himself and Mr. Kennedy) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
At the end of the bill, add the following:
SEC. __. COLOR CERTIFICATION REPORTS.
Section 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379e) is amended by adding at the end the following:
``(g) Color Certification Reports.--Not later than--
``(1) 90 days after the close of a fiscal year in which color certification fees are collected, the Secretary shall submit to Congress a performance report for such fiscal year on the number of batches of color additives approved, the average turn around time for approval, and quantifiable goals for improving laboratory efficiencies; and
``(2) 120 days after the close of a fiscal year in which color certification fees are collected, the Secretary shall submit to Congress a financial report for such fiscal year that includes all fees and expenses of the color certification program, the balance remaining in the fund at the end of the fiscal year, and anticipated costs during the next fiscal year for equipment needs and laboratory improvements of such program.''.
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SA 1051. Mr. STEVENS (for himself and Ms. Murkowski) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
At the end of the bill, add the following:
SEC. __. CONSULTATION REGARDING GENETICALLY ENGINEERED
SEAFOOD PRODUCTS.
The Commissioner of Food and Drugs shall consult with the Assistant Administrator of the National Marine Fisheries Service of the National Oceanic and Atmospheric Administration before granting final approval to use or produce a genetically engineered seafood product.
______
SA 1052. Mr. CORKER submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
``SEC. __. PROHIBITION ON COMMINGLING.
``(a) In General.--Notwithstanding any other provision of this Act (or an amendment made by this Act) a registered importer shall not commingle a prescription drug imported into the United States under this Act (or amendment) with another prescription drug, regardless of whether such other drug is a domestic prescription drug or a prescription drug from a permitted country.
``(b) Label.--A registered importer (including an Internet pharmacy) that dispenses a prescription drug imported from a permitted country shall affix on each dispensed container of the prescription drug the label required under subsection
(c), unless such a label is already affixed to the container.
``(c) Requirements.--Each prescription drug imported under this Act (or an amendment made by this Act) shall be in a container that bears a label stating, in prominent and conspicuous type--
``(1) the following statement: `This drug has been imported from ______.' with the name of the permitted country from which the prescription drug has imported in the blank space; and
``(2) that the container complies with any other applicable requirement of this Act.''.
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SA 1053. Mr. ENZI (for himself, Mr. Kennedy, Mr. Dodd, and Mrs. Clinton) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
On page 226, line 4, strike ``later'' and insert ``if the determination made under subsection (d)(3) is made less''.
On page 228, line 3, strike ``later'' and insert ``if the determination made under subsection (d)(3) is made less''.
On page 233, line 12, insert ``, such as expertise in child and adolescent psychiatry,'' after ``expertise''.
On page 233, line 15, strike ``including'' and insert
``which may include''.
On page 233, between lines 18 and 19, insert the following:
``(C) Action by committee.--The committee established under this paragraph may perform a function under this section using appropriate members of the committee under subparagraph
(B) and need not convene all members of the committee under subparagraph (B) in order to perform a function under this section.
``(D) Documentation of committee action.--The committee established under this paragraph shall document for each function under paragraphs
(2) and (3), which members of the committee participated in such function.
On page 234, line 1, strike ``determine'' and insert ``make a recommendation to the Secretary''.
On page 235, line 2, strike ``and''.
On page 235, line 6, strike ``.'';'' and insert ``; and''
On page 235, between lines 6 and 7, insert the following:
``(H) the number of times the committee established under paragraph (1) made a recommendation to the Secretary under paragraph (3), the number of times the Secretary did not follow such a recommendation to accept reports under subsection (d)(3), and the number of times the Secretary did not follow such a recommendation to reject such reports under section (d)(3).
``(5) Committee.--The committee established under paragraph
(1) is the committee established under section 505B(f)(1).'';
On page 260, lines 17 through 19, strike ``of a letter, or a written request under section 505A that was declined by the sponsor or holder'' and insert ``of a written request under section 505A that was declined by the sponsor or holder, or a letter referencing such declined written request,''.
On page 261, line 3, strike ``appropriate'' and insert
``appropriate, for the labeled indication or indications,''.
On page 263, line 14, insert ``, such as expertise in child and adolescent psychiatry,'' after ``expertise''
On page 263, between lines 19 and 20, insert the following and redesignate the remaining paragraphs accordingly:
``(2) Action by the committee.--The committee established under paragraph (1) may perform a function under this section using appropriate members of the committee under paragraph
(1) and need not convene all members of the committee under paragraph (1) in order to perform a function under this section.
``(3) Documentation of committee action.--For each drug or biological product, the committee established under this paragraph shall document for each function under paragraph
(4) or (5), which members of the committee participated in such function.
On page 265, between lines 18 and 19, insert the following:
``(7) Committee.--The committee established under paragraph
(1) is the committee established under section 505A(f)(1).
On page 289, line 16, strike ``SURVEILLANCES'' and insert
``POSTMARKET SURVEILLANCE''.
On page 289, line 17, strike ``Surveillances'' and insert
``Surveillance''.
On page 290, strike lines 9 through 12 and insert the following:
``(iii) that is intended to be--
``(I) implanted in the human body for more than 1 year; or
``(II) a life-sustaining or life-supporting device used outside a device user facility.
On page 290, line 15, strike ``of an'' and all that follows through ``section 510(k) only for'' on line 19, and insert
``or clearance of''.
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SA 1054. Mr. FEINGOLD submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. __. PUBLICATION OF ANNUAL REPORTS.
(a) In General.--The Commissioner on Food and Drugs shall annually submit to Congress and publish on the Internet website of the Food and Drug Administration, a report concerning the results of the Administration's pesticide residue monitoring program, that includes--
(1) information and analysis similar to that contained in the report entitled ``Food and Drug Administration Pesticide Program Residue Monitoring 2003'' as released in June of 2005;
(2) based on an analysis of previous samples, an identification of products or countries (for imports) that require special attention and additional study based on a comparison with equivalent products manufactured, distributed, or sold in the U.S. (including details on the plans for such additional studies), including in the initial report (and subsequent reports as determined necessary) the results and analysis of the Ginseng Dietary Supplements Special Survey as described on page 13 of the report entitled
``Food and Drug Administration Pesticide Program Residue Monitoring 2003'';
(3) information on the relative number of interstate and imported shipments of each tested commodity that were sampled, including recommendations on whether sampling is statistically significant, provides confidence intervals or other related statistical information, and whether the number of samples should be increased and the details of any plans to provide for such increase; and
(4) a description of whether certain commodities are being improperly imported as another commodity, including a description of additional steps that are being planned to prevent such smuggling.
(b) Initial Reports.--Annual reports under subsection (a) for fiscal years 2004 through 2006 may be combined into a single report, by not later than June 1, 2008, for purposes of publication under subsection (a). Thereafter such reports shall be completed by June 1 of each year for the data collected for the year that was 2-years prior to the year in which the report is published.
(c) Memorandum of Understanding.--The Commissioner of Food and Drugs, the Administrator of the Food Safety and Inspection Service, the Department of Commerce, and the head of the Agricultural Marketing Service shall enter into a memorandum of understanding to permit inclusion of data in the reports under subsection (a) relating to testing carried out by the Food Safety and Inspection Service and the Agricultural Marketing Service on meat, poultry, eggs, and certain raw agricultural products, respectively.
______
SA 1055. Mr. LEVIN submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. __. SAFETY OF FOOD ADDITIVES.
Not later than 90 days after the date of enactment of this Act, the Food and Drug Administration shall issue a report on the question of whether substances used to preserve the appearance of fresh meat may create any health risks, or mislead consumers.
______
SA 1056. Mr. REED (for himself, and Mr. Isakson) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. __. REPORT BY THE FOOD AND DRUG ADMINISTRATION REGARDING
LABELING INFORMATION ON THE RELATIONSHIP
BETWEEN THE USE OF INDOOR TANNING DEVICES AND
DEVELOPMENT OF SKIN CANCER OR OTHER SKIN
DAMAGE.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), acting through the Commissioner of Food and Drugs, shall determine--
(1) whether the labeling requirements for indoor tanning devices, including the positioning requirements, provide sufficient information to consumers regarding the risks that the use of such devices pose for the development of irreversible damage to the eyes and skin, including skin cancer; and
(2)(A) whether modifying the warning label required on tanning beds to read, ``Ultraviolet radiation can cause skin cancer'', or any other additional warning, would communicate the risks of indoor tanning more effectively; or
(B) whether there is no warning that would be capable of adequately communicating such risks.
(b) Consumer Testing.--In making the determinations under subsection (a), the Secretary shall conduct appropriate consumer testing, using the best available methods for determining consumer understanding of label warnings.
(c) Public Hearings; Public Comment.--The Secretary shall hold public hearings and solicit comments from the public in making the determinations under subsection (a).
(d) Report.--Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit to the Congress a report that provides the determinations under subsection (a). In addition, the Secretary shall include in the report the measures being implemented by the Secretary to significantly reduce the risks associated with indoor tanning devices.
SA 1057. Mr. GREGG submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
TITLE _--INTERNET PHARMACIES
SEC. _01. SHORT TITLE.
This title may be cited as the ``Safe Internet Pharmacy Act of 2007''.
SEC. _02. INTERNET PHARMACIES.
(a) Internet Pharmacies.--Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 510 the following:
``SEC. 511. INTERNET PHARMACIES.
``(a) Definitions.--In this section:
``(1) Advertising service provider.--The term `advertising service provider' means an advertising company that contracts with a provider of an interactive computer service (as defined in section 230(f) of the Communications Act of 1934
(47 U.S.C. 230(f)) to provide advertising on the Internet.
``(2) Designated payment system.--
``(A) In general.--The term `designated payment system' means a system used by a person described in subparagraph (B) to effect a credit transaction, electronic fund transfer, or money transmitting service that the Board determines, by regulation or order, is regularly used in connection with, or to facilitate restricted transactions.
``(B) Persons described.--A person referred to in subparagraph (A) is--
``(i) a creditor;
``(ii) a credit card issuer;
``(iii) a financial institution;
``(iv) an operator of a terminal at which an electronic fund transfer may be initiated;
``(v) a money transmitting business; or
``(vi) a participant in an international, national, regional, or local network constructed primarily to effect a credit transaction, electronic fund transfer, or money transmitting service.
``(3) Federal functional regulator.--The term `Federal functional regulator' has the meaning given the term in section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809).
``(4) Internet pharmacy.--The term `Internet pharmacy' means a person that offers to dispense or dispenses in the United States a prescription drug through an Internet website in interstate commerce, regardless of whether the physical location of the principal place of business of the Internet pharmacy is in the United States or in another country.
``(5) Prescription drug.--The term `prescription drug' means a drug described in section 503(b) that is approved by the Secretary under section 505.
``(6) Restricted transaction.--The term `restricted transaction' means a transaction or transmittal, on behalf of a individual who places an unlawful Internet pharmacy request to any person engaged in the operation of an unlicensed Internet pharmacy, of--
``(A) credit, or the proceeds of credit, extended to or on behalf of the individual for the purpose of the unlawful Internet request (including credit extended through the use of a credit card);
``(B) an electronic fund transfer or funds transmitted by or through a money transmitting business, or the proceeds of an electronic fund transfer or money transmitting service, from or on behalf of the individual for the purpose of the unlawful Internet request;
``(C) a check, draft, or similar instrument which is drawn by or on behalf of the individual for the purpose of the unlawful Internet request and is drawn on or payable at or through any financial institution; or
``(D) the proceeds of any other form of financial transaction (identified by the Board by regulation) that involves a financial institution as a payor or financial intermediary on behalf of or for the benefit of the individual for the purpose of the unlawful Internet request.
``(7) Treating provider.--The term `treating provider' means a health care provider licensed in the United States who is authorized to prescribe medications and who--
``(A)(i) performs a documented patient evaluation
(including a patient history and physical examination) of an individual, portions of which may be conducted by other health professionals;
``(ii) discusses with the individual the treatment options of the individual and the risks and benefits of treatment; and
``(iii) maintains contemporaneous medical records concerning the individual; or
``(B) provides care to an individual as part of an on-call or cross-coverage arrangement with a health care provider described in subparagraph (A).
``(8) Unlawful internet pharmacy request.--The term
`unlawful Internet pharmacy request' means the request, or transmittal of a request, made to an unlicensed Internet pharmacy for a prescription drug by mail (including a private carrier), facsimile, telephone, or electronic mail, or by a means that involves the use, in whole or in part, of the Internet.
``(9) Unlicensed internet pharmacy.--The term `unlicensed Internet pharmacy' means an Internet pharmacy that is not licensed under this section.
``(10) Other definitions.--
``(A) Board.--The term `Board' means the Board of Governors of the Federal Reserve System.
``(B) Credit; creditor; credit card.--The terms `credit',
`creditor', and `credit card' have the meanings given the terms in section 103 of the Truth in Lending Act (15 U.S.C. 1602).
``(C) Electronic fund transfer.--The term `electronic fund transfer'--
``(i) has the meaning given the term in section 903 of the Electronic Fund Transfer Act (15 U.S.C. 1693a); and
``(ii) includes any fund transfer covered under article 4A of the Uniform Commercial Code, as in effect in any State.
``(D) Financial institution.--The term `financial institution'--
``(i) has the meaning given the term in section 903 of the Electronic Transfer Fund Act (15 U.S.C. 1693a); and
``(ii) includes a financial institution (as defined in section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809)).
``(E) Money transmitting business; money transmitting service.--The terms `money transmitting business' and `money transmitting service' have the meanings given the terms in section 5330(d) of title 31, United States Code.
``(b) In General.--An Internet pharmacy may only dispense or offer to dispense a prescription drug to a person in the United States in accordance with this section.
``(c) Licensing of Internet Pharmacies.--
``(1) In general.--An Internet pharmacy shall be licensed by the Secretary in accordance with this section prior to offering to dispense or dispensing a prescription drug to an individual.
``(2) Conditions for licensing.--
``(A) Application requirements.--An Internet pharmacy shall submit to the Secretary an application that includes--
``(i)(I) in the case of an Internet pharmacy located in the United States, verification that, in each State in which the Internet pharmacy engages in dispensing or offering to dispense prescription drugs, the Internet pharmacy, and all employees and agents of the Internet pharmacy, is in compliance with applicable Federal and State laws regarding--
``(aa) the practice of pharmacy, including licensing laws and inspection requirements; and
``(bb) the manufacturing and distribution of controlled substances, including with respect to mailing or shipping controlled substances to consumers; or
``(II) in the case of an Internet pharmacy whose principal place of business is located outside the United States, verification that--
``(aa) all employees and agents of the Internet pharmacy are in compliance with applicable Federal and State laws regarding the practice of pharmacy, including licensing laws and inspection requirements;
``(bb) the Internet pharmacy is in compliance with applicable Federal and State laws regarding the practice of pharmacy, including licensing laws and inspection requirements;
``(cc) the Internet pharmacy expressly and affirmatively agrees to provide and maintain an agent for service of process in the United States;
``(dd) the Internet pharmacy expressly and affirmatively agrees to be subject to the jurisdiction of the United States and any of its States or territories where it engages in commerce; and
``(ee) the Internet pharmacy agrees to affix to each shipping container of drugs to be shipped in the United States such markings as the Secretary determines to be necessary to identify that the shipment is from a licensed Internet pharmacy, which may include anticounterfeiting or track-and-trace technologies;
``(ii) verification that the person that owns the Internet pharmacy has not had a license for an Internet pharmacy terminated by the Secretary, and that no other Internet pharmacy owned by the person has had a license under this subsection that has been terminated by the Secretary;
``(iii) verification from the person that owns the Internet pharmacy that the person will permit inspection of the facilities and business practices of the Internet pharmacy by the Secretary to the extent necessary to determine whether the Internet pharmacy is in compliance with this subsection;
``(iv) in the case of an agreement between a patient and an Internet pharmacy that releases the Internet pharmacy, and any employee or agent of the Internet pharmacy, from liability for damages arising out of the negligence of the Internet pharmacy, an assurance that such a limitation of liability shall be null and void;
``(v) verification that the Internet pharmacy expressly and affirmatively agrees to provide the Secretary with the identity of any providers of interactive computer services that provide host services or advertising services for the Internet pharmacy; and
``(vi) assurance that the Internet pharmacy will comply with the requirements under subparagraphs (B) and (C).
``(B) Identification requirements.--An Internet pharmacy shall post in a clear and visible manner, on each page of the website of the Internet pharmacy or by a link to a separate page, the following information:
``(i) The street address, city, ZIP Code or comparable mail code, State (or comparable entity), country, and telephone number of--
``(I) each place of business of the Internet pharmacy; and
``(II) the name of the supervising pharmacist of the Internet pharmacy and each individual who serves as a pharmacist for purposes of the Internet pharmacy website.
``(ii) The names of all States in which the Internet pharmacy and the pharmacists employed by the Internet pharmacy are licensed or otherwise authorized to dispense prescription drugs.
``(iii) If the Internet pharmacy makes referrals to, or solicits on behalf of, a health care practitioner or group of practitioners in the United States for prescription services--
``(I) the name, street address, city, ZIP Code or comparable mail code, State, and telephone number of the practitioner or group; and
``(II) the name of each State in which each practitioner is licensed or otherwise authorized to prescribe drugs.
``(iv) A statement that the Internet pharmacy will dispense prescription drugs only after receipt of a valid prescription from a treating provider.
``(v) A distinctive tamper resistant seal to identify that the Internet pharmacy is licensed.
``(C) Professional services requirements.--An Internet pharmacy shall carry out the following:
``(i) Maintain patient medication profiles and other related data in a readily accessible format organized to facilitate consultation with treating providers, caregivers, and patients.
``(ii) Conduct prospective drug use reviews before dispensing medications or medical devices.
``(iii) Ensure patient confidentiality and the protection of patient identity and patient-specific information, in accordance with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996.
``(iv) Offer interactive and meaningful consultation by a licensed pharmacist to the caregiver or patient before and after the time at which the Internet pharmacy dispenses the drug.
``(v)(I) Establish a mechanism for patients to report errors and suspected adverse drug reactions.
``(II) Document in the reporting mechanism the response of the Internet pharmacy to those reports.
``(III) Submit those reports within 3 days of receipt and the response of the Internet pharmacy to the Food and Drug Administration in a manner determined appropriate by the Secretary.
``(vi) Develop a system to inform caregivers and patients about drug recalls.
``(vii) Educate caregivers and patients about the appropriate means of disposing of expired, damaged, or unusable medications.
``(viii) Assure that the sale of a prescription drug is in accordance with a valid prescription from the treating provider of the individual.
``(ix)(I) Verify the validity of the prescription of an individual by using 1 of the following methods:
``(aa) If the prescription for any drug other than a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) is received from an individual or the treating provider of the individual by mail (including a private carrier), or from the treating provider of the individual by electronic mail, the validity of the prescription shall be confirmed in accordance with all applicable Federal and State laws.
``(bb) If the prescription is for a controlled substance
(as defined in section 102 of the Controlled Substances Act), the validity of the prescription shall be confirmed with the treating provider as described in subclause (II).
``(II) When seeking verification of a prescription of an individual under subclause (I)(bb), an Internet pharmacy shall provide to the treating provider the following information:
``(aa) The full name and address of the individual.
``(bb) Identification of the prescription drug.
``(cc) The quantity of the prescription drug to be dispensed.
``(dd) The date on which the individual presented the prescription to the Internet pharmacy.
``(ee) The date and time of the verification request.
``(ff) The name of a contact person at the Internet pharmacy, including a voice telephone number, electronic mail address, and facsimile telephone number.
``(III) A prescription is verified under subclause (I)(bb) only if 1 of the following occurs:
``(aa) The treating provider confirms, by direct communication with the Internet pharmacy, that the prescription is accurate.
``(bb) The treating provider informs the Internet pharmacy that the prescription is inaccurate and provides the accurate prescription.
``(IV) An Internet pharmacy shall not fill a prescription if--
``(aa) a treating provider informs the Internet pharmacy within 72 hours after receipt of a communication under subclause (I)(bb) that the prescription is inaccurate or expired; or
``(bb) the treating provider does not respond within that time.
``(x) Maintain, for such period of time as the Secretary shall prescribe by regulation, a record of all direct communications with a treating provider regarding the dispensing of a prescription drug, including verification of the prescription.
``(3) Licensure procedure.--
``(A) Action by secretary.--On receipt of a complete licensing application from an Internet pharmacy under paragraph (2), the Secretary shall--
``(i) assign an identification number to the Internet pharmacy;
``(ii) notify the applicant of the receipt of the licensing application; and
``(iii) if the Internet pharmacy is in compliance with the conditions under paragraph (2), issue a license not later than 60 days after receipt of a licensing application from the Internet pharmacy.
``(B) Electronic filing.--
``(i) In general.--For the purpose of reducing paperwork and reporting burdens, the Secretary shall require the use of electronic methods of submitting to the Secretary a licensing application required under this section and provide for electronic methods of receiving the applications.
``(ii) Authentication.--In providing for the electronic submission of such licensing applications under this section, the Secretary shall ensure that adequate authentication protocols are used to allow identification of the Internet pharmacy and validation of the data as appropriate.
``(4) Database.--
``(A) In general.--The Secretary shall compile, maintain, and periodically update a database of the Internet pharmacies licensed under this section.
``(B) Availability.--The Secretary shall make the database described under subparagraph (A) and information submitted by the licensee under paragraph (2)(B) available to the public on an Internet website and through a toll-free telephone number.
``(5) Fees.--
``(A) In general.--
``(i) Licensing application fee.--The Secretary shall establish a licensing application fee to be paid by all applicants.
``(ii) Renewal fee.--The Secretary shall establish a yearly renewal fee to be paid by all Internet pharmacies licensed under this section.
``(B) Collection.--
``(i) Collection of licensing application fee.--A licensing application fee payable for the fiscal year in which the Internet pharmacy submits a licensing application, as established under subparagraph (C), shall be payable upon the submission to the Secretary of such licensing application.
``(ii) Collection of renewal fees.--After the licensing application fee is paid for the first fiscal year of licensure, the yearly renewal fee, as established under subparagraph (C), shall be payable on or before October 1 of each subsequent fiscal year.
``(iii) One fee per internet pharmacy.--The licensing application fee and yearly renewal fee shall be paid only once for each Internet pharmacy for a fiscal year in which the fee is payable.
``(iv) Excess fees.--Any amount collected by the Secretary under this paragraph for a fiscal year that is in excess of the costs of enforcing the requirements of this section for such fiscal year shall be deposited in the Treasury.
``(C) Fee amount.--The amount of the licensing application fee and the yearly renewal fee for an Internet pharmacy shall be determined each year by the Secretary based on 133 percent of the anticipated costs to the Secretary of enforcing the requirements of this section in the subsequent fiscal year.
``(D) Annual fee determination.--
``(i) In general.--Not later than 60 days before the beginning of each fiscal year beginning after September 30, 2007, the Secretary shall determine the amount of the licensing application fee and the yearly renewal fee for that fiscal year.
``(ii) Publication of fee amount.--Not later than 60 days before each fiscal year, the Secretary shall publish the amount of the licensing application fee and the yearly renewal fee under this section for that fiscal year and provide for a period of 30 days for the public to provide written comments on the fees.
``(E) Use of fees.--The fees collected under this section shall be used, without further appropriation, to carry out this section.
``(F) Failure to pay fee.--
``(i) Due date.--A fee payable under this section shall be paid by the date that is 30 days after the date on which the fee is due.
``(ii) Failure to pay.--If an Internet pharmacy subject to a fee under this section fails to pay the fee by the date specified under clause (i), the Secretary shall not permit the Internet pharmacy to engage in the dispensing of drugs as described under this section until all such fees owed by the Internet pharmacy are paid.
``(G) Reports.--Beginning with fiscal year 2008, not later than 60 days after the end of each fiscal year during which licensing application fees are collected under this section, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that describes--
``(i) implementation of the licensing fee authority during the fiscal year; and
``(ii) the use by the Secretary of the licensing fees collected during the fiscal year for which the report is made.
``(6) Suspension.--
``(A) In general.--If the Secretary determines that an Internet pharmacy is engaged in a pattern of violations of any of the requirements of this Act, the Secretary may immediately order the suspension of the license of the Internet pharmacy.
``(B) Appeal of suspension order.--An Internet pharmacy subject to a suspension order under subparagraph (A) may appeal the suspension order to the Secretary. Not later than 30 days after an appeal is filed, the Secretary, after providing opportunity for an informal hearing, shall affirm or terminate the order.
``(C) Failure to act.--If, during the 30-day period specified in subparagraph (B), the Secretary fails to provide an opportunity for a hearing or to affirm or terminate the order, the order shall be deemed to be terminated.
``(D) No judicial review.--An order under this paragraph shall not be subject to judicial review.
``(7) Termination of license.--The Secretary may terminate a license issued under this subsection, after notice to the Internet pharmacy and an opportunity for a hearing, and if the Secretary determines that the Internet pharmacy--
``(A) has demonstrated a pattern of noncompliance with this section;
``(B) has made an untrue statement of material fact in its licensing application; or
``(C) is in violation of any applicable Federal or State law relating to the dispensing of a prescription drug.
``(8) Renewal evaluation.--
``(A) In general.--Before renewing a license of an Internet pharmacy under this subsection, the Secretary shall conduct an evaluation to determine whether the Internet pharmacy is in compliance with this section.
``(B) Evaluation of internet pharmacies.--At the discretion of the Secretary and as applicable, an evaluation under subparagraph (A) may include testing of the Internet pharmacy website or other systems through which the Internet pharmacy communicates with consumers, and a physical inspection of the records and premises of the pharmacy.
``(9) Contract for operation of program.--
``(A) In general.--The Secretary may award a contract under this subsection for the operation of the licensing program.
``(B) Term.--The duration of a contract under subparagraph
(A) shall not exceed 5 years and may be renewable.
``(C) Performance review.--The Secretary shall annually review performance under a contract under subparagraph (A).
``(d) Providers of Interactive Computer Services or Advertising Services.--No provider of interactive computer services (as defined in section 230(f) of the Communications Act of 1934 (47 U.S.C. 230(f)) or an advertising service provider shall be liable under this section on account of another person's selling or dispensing of a prescription drug, so long as the provider of the interactive computer service or the advertising service provider does not own or exercise corporate control over such person.
``(e) Policies and Procedures Required To Prevent Payments for Unlawful Internet Pharmacy Requests.--
``(1) Regulations.--Not later than 180 days after designating a system under subsection (a)(2), the Board shall promulgate regulations that require--
``(A) an operator of a credit card system that is a designated payment system, an operator of an international, national, or local network used to effect a credit transaction, electronic fund transfer, or money transmitting service that is a designated payment system, and an operator of any other designated payment system specified by the Board that is centrally managed and is primarily engaged in the transmission and settlement of credit transactions, electronic transfers, or money transmitting services where at least 1 party to the transaction or transfer is an individual; and
``(B) in the case of a designated payment system, other than a designated payment system described in subparagraph
(A), a person described in subsection (a)(2)(B);to establish policies and procedures that are reasonably designed to prevent the introduction of restricted transactions into a designated payment system or the completion of restricted transactions using a designated payment system.
``(2) Requirements for policies and procedures.--In promulgating regulations under paragraph (1), the Board shall--
``(A) identify types of policies and procedures, including nonexclusive examples, that shall be considered to be reasonably designed to identify and reasonably designed to prevent the introduction of a restricted transaction in a designated payment or the completion of restricted transactions using a designated payment system; and
``(B) to the extent practicable, permit any designated payment system, or person described in subsection (a)(2)(B), as applicable, to choose among alternative means of preventing the introduction or completion of restricted transactions.
``(3) No liability for blocking or refusing to honor restricted transaction.--
``(A) In general.--A designated payment system, or a person described in subsection (a)(2)(B), that is subject to a regulation or an order issued under this subsection, and any participant in such payment system, that--
``(i) prevents or otherwise refuses to honor restricted transactions, in an effort to implement the policies and procedures required under this subsection or to otherwise comply with this section, shall not be liable to any party for such action; and
``(ii) prevents or otherwise refuses to honor a nonrestricted transaction in an effort to implement the policies and procedures under this subsection or to otherwise comply with this section, shall not be liable to any party for such action.
``(B) Compliance with this subsection.--A person described in subsection (a)(2)(B) meets the requirements of this subsection, if any, if the person relies on and complies with the policies and procedures of a designated payment system of which the person is a member or in which the person is a participant, and such policies and procedures of the designated payment system comply with the requirements of the regulations under paragraph (1)(B).
``(4) Enforcement.--
``(A) In general.--This subsection shall be enforced by the Federal functional regulators and the Federal Trade Commission under applicable law in the manner provided in section 505(a) of the Gramm-Leach-Bliley Act (21 U.S.C. 6805(a)).
``(B) Factors to be considered.--In considering any enforcement action under this subsection against a payment system or person described in subsection (a)(2)(B), the Federal functional regulators and the Federal Trade Commission shall consider the following factors:
``(i) The extent to which the payment system or person knowingly permits restricted transactions.
``(ii) The history of the payment system or person in connection with permitting restricted transactions.
``(iii) The extent to which the payment system or person has established and is maintaining policies and procedures in compliance with regulations prescribed under this subsection.
``(iv) The feasibility that any specific remedy prescribed can be implemented by the payment system or person without substantial deviation from normal business practice.
``(v) The costs and burdens the specific remedy will have on the payment system or person.
``(f) Reports Regarding Internet-Related Violations of Federal and State Laws on Dispensing of Drugs.--The Secretary shall, pursuant to the submission of an application meeting criteria prescribed by the Secretary, make an award of a grant or contract to an entity with experience in developing and maintaining systems for the purpose of--
``(1) identifying Internet pharmacy websites that are not licensed or that appear to be operating in violation of Federal or State laws concerning the dispensing of drugs;
``(2) reporting such Internet pharmacy websites to State medical licensing boards and State pharmacy licensing boards, and to the Attorney General and the Secretary, for further investigation; and
``(3) submitting, for each fiscal year for which the award under this subsection is made, a report to the Secretary describing investigations undertaken with respect to violations described in paragraph (1).
``(g) Transactions Permitted.--A designated payment system or person subject to a regulation or an order issued under subsection (e) may engage in transactions with licensed and unlicensed Internet pharmacies in connection with investigating violations or potential violations of any rule or requirement adopted by the payment system or person in connection with complying with subsection (e). A person subject to a regulation or an order issued under subsection
(e) and the agents and employees of that person shall not be found to be in violation of, or liable under, any Federal, State, or other law for engaging in any such transaction.
``(h) Relation to State Laws.--No requirement, prohibition, or liability may be imposed on a designated payment system or person subject to a regulation or an order issued under subsection (e) under the laws of any State with respect to any payment transaction by an individual because the payment transaction involves a payment to an Internet pharmacy.
``(i) Timing of Requirements.--A designated payment system or a person subject to a regulation under subsection (e) shall adopt policies and procedures reasonably designed to comply with any regulations required under subsection (e) not later than 180 days after the date on which such final regulations are issued.''.
(b) Prohibited Acts.--Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:
``(hh)(1) The sale, under section 511, of a drug that is not a prescription drug, the sale of such a prescription drug without a valid prescription from a treating provider, or the ownership or operation of an Internet pharmacy, in violation of section 511.
``(2) The representation by advertisement, sales presentation, direct communication (including telephone, facsimile, or electronic mail), or otherwise by an Internet pharmacy, that a prescription drug may be obtained from the Internet pharmacy without a prescription, in violation of section 511.
``(3) The advertisement related to a prescription drug through any media including sales presentation, direct communication (including telephone, facsimile, or electronic mail), by an unlicensed Internet pharmacy.
``(4) The provision of an untrue statement of material fact in the licensing application of an Internet pharmacy.
``(5) For purposes of this subsection, any term used in this subsection that is also used in section 511 shall have the meaning given that term in section 511.''.
(c) Links to Unlicensed Internet Pharmacies.--Section 302 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332) is amended by adding at the end the following:
``(c)(1) In the case of a violation of section 511 relating to an unlicensed Internet pharmacy (as defined in such section 511), the district courts of the United States and the United States courts of the territories shall have jurisdiction to order a provider of an interactive computer service to remove, or disable access to, links to a website violating that section that resides on a computer server that the provider controls or operates.
``(2) Relief under paragraph (1)--
``(A) shall be available only after provision to the provider of notice and an opportunity to appear;
``(B) shall not impose any obligation on the provider to monitor its service or to affirmatively seek facts indicating activity violating section 511;
``(C) shall specify the provider to which the relief applies; and
``(D) shall specifically identify the location of the website to be removed or to which access is to be disabled.''.
(d) Regulations.--
(1) In general.--Not later than 1 year after the date of enactment of this title, the Secretary of Health and Human Services shall promulgate interim final regulations to carry out the amendments made by this section.
(2) Effective date.--The requirement of licensure under section 511 of the Federal Food, Drug, and Cosmetic Act (as added by this section) shall take effect on the date determined by the Secretary of Health and Human Services but in no event later than 90 days after the effective date of the interim final regulations under paragraph (1).
(e) Penalties.--Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the following:
``(g) Notwithstanding subsection (a), any person who knowingly violates paragraph (1), (2), (3), or (4) of section 301(hh) shall be imprisoned for not more than 10 years or fined in accordance with title 18, United States Code, or both.''.
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SA 1058. Mr. DeMINT (for himself, Mr. Coburn, and Mr. Martinez) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. __. SENSE OF THE SENATE REGARDING CERTAIN PATENT
INFRINGEMENTS.
(a) Findings.--The Senate makes the following findings:
(1) The value of American innovation in developing life-saving prescription drugs saves millions of lives around the world each year.
(2) The protection of intellectual property is vital to the continued development of new and life-saving drugs and future growth of the United States economy.
(3) In order to maintain the global competitiveness of the United States, the United States Trade Representative's Office of Intellectual Property and Innovation develops and implements trade policy in support of vital American innovations, including innovation in the pharmaceutical and medical technology industries.
(4) The United States Trade Representative also provides trade policy leadership and expertise across the full range of interagency initiatives to enhance protection and enforcement of intellectual property rights.
(5) When other countries do not respect the intellectual property of American drug companies, all patients suffer because of diminished incentives to develop new life-saving medications and the American economy is unfairly harmed.
(6) Strong intellectual property protection, including patent, copyright, trademark, and data protection plays an integral role in fostering economic growth and development and ensuring patient access to the most effective medicines around the world.
(7) Certain countries have engaged in unfair price manipulation and abuse of compulsory licensing. This results in Americans bearing the majority of research and development costs for the world, undermines the value of existing United States pharmaceutical patents and could impede access to important therapies.
(8) There is a growing global threat of counterfeit medicines and increased need for the United States Trade Representative and other United States agencies to use available trade policy measures to strengthen laws and enforcement abroad to prevent harm to United States patients and patients around the world.
(b) Sense of the Senate.--It is the sense of the Senate that--
(1) the United States Trade Representative should use all the tools at the disposal of the Trade Representative to deal with violations of intellectual property rights, including--
(A) bilateral engagement with United States trading partners;
(B) transparency of the annual ``Special 301'' review and reviews of compliance with the intellectual property requirements of countries with respect to which the United States grants trade preferences;
(C) negotiation of intellectual property provisions as part of bilateral and regional trade agreements; and
(D) multilateral engagement through the World Trade Organization (WTO); and
(2) the United States Trade Representative should develop and implement a strategic plan to address the problem of countries that infringe upon American pharmaceutical intellectual property rights and the problem of countries that engage in price manipulation.
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SA 1059. Mr. SESSIONS (for himself, Mrs. Lincoln, Mr. Cochran, Mr. Pryor, Mr. Lott, and Mr. Shelby) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. __. ENHANCED AQUACULTURE AND SEAFOOD INSPECTION.
(a) Findings.--Congress finds the following:
(1) In 2007, there has been an overwhelming increase in the volume of aquaculture and seafood that has been found to contain substances that are not approved for use in food in the United States.
(2) As of May 2007, inspection programs are not able to satisfactorily accomplish the goals of ensuring the food safety of the United States.
(3) To protect the health and safety of consumers in the United States, the ability of the Secretary of Health and Human Services to perform inspection functions must be enhanced.
(b) Heightened Inspections.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall, by regulation, enhance, as necessary, the inspection regime of the Food and Drug Administration for aquaculture and seafood, consistent with obligations of the United States under international agreements and United States law.
(2) Content.--The Secretary shall ensure that the regulations promulgated under paragraph (1) to enhance the inspection regime--
(A) ensure that aquaculture and seafood products are not contaminated with substances that are not approved for use in food in the United States;
(B) include the authority to refuse imports of such products from a foreign facility if a requested inspection of the foreign facility is refused or unnecessarily delayed;
(C) take into account whether the United States has a cooperative agreement regarding aquaculture and seafood inspection; and
(D) provide for an assessment of the risk associated with particular contaminants.
(c) Report to Congress.--Not later than 90 days after the date of enactment of this Act, the Secretary shall submit to Congress a report that describes--
(1) the specifics of the aquaculture and seafood inspection program; and
(2) the feasibility of developing a traceability system for all catfish and seafood products, both domestic and imported, for the purpose of identifying the processing plant of origin of such products.
(d) Partnerships With States.--Upon the request by any State, the Secretary may enter into partnership agreements, as soon as practicable after the request is made, to implement inspection programs regarding the importation of aquaculture and seafood.
(e) Authorization of Appropriations.--There are authorized to be appropriated such sums as may be necessary to carry out this section.
______
SA 1060. Mr. HATCH (for himself and Mr. Kennedy) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. __. FOOD AND DRUG ADMINISTRATION FUNDING SUBMISSION.
Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.), as amended by this Act, is amended by adding at the end the following:
``SEC. 714. FOOD AND DRUG ADMINISTRATION FUNDING SUBMISSION.
``For each of fiscal years 2009 through 2013, the Commissioner of Food and Drugs shall prepare and submit, directly to the President for review and transmittal to Congress, an annual Food and Drug Administration funding submission estimate (including the number and type of personnel needs for the Food and Drug Administration), after reasonable opportunity for comment (but without change) by the Secretary.''.
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