Dear Dr. Kopelow:
Thank you for your informative response to our letter of Dec. 14, 2006. The insightyou provided on the accreditation process for continuing medical education (CME) helped us inour exploration of the pharmaceutical industry's use of educational grant funding. Given theincreasing Medicare and Medicaid expenditures on prescription drugs, the United States SenateCommittee on Finance (Committee) has an interest in reviewing how pharmaceuticalmanufacturers use grant funding in ways that may increase program costs or endangerbeneficiaries. On April 25, 2007, we released a Committee Staff Report summarizing the resultsof our inquiry, and provided you a copy. The full text of this report is available on theCommittee's website at http://www.senate.gov/.
Our inquiry revealed that the pharmaceutical industry spends more than a billion dollars ayear to fund CME programs that are accredited by the Accreditation Council for ContinuingMedical Education (ACCME). Funding of ACCME-accredited programs represents asubstantial portion of drug company spending on educational grants. Our inquiry also revealedthat drug companies typically fund CME as part of a broader business strategy to support thecompany's brands. Many of the drug companies informed us that they rely on a provider'sACCME-accreditation to demonstrate that their grant money is spent on education and not onmarketing. In keeping with ACCME's policies, ACCME-accredited CME should differ from thedrug company's own marketing and promotional activities in that the drug company should notexercise control over the content of CME. Our letter to ACCME sought information about howACCME ensures that the CME providers it accredits actually operate with the required level ofindependence, and without allowing program content to be controlled or influenced by the drugcompany sponsors.
Your response helped us understand the process by which ACCME oversees theactivities of CME providers. You reported that ACCME reviews accredited CME providers atintervals of two, four, or six years, depending on the CME provider's past history of compliance.In conducting these re-accreditation reviews, ACCME primarily relies on three sources ofinformation: (1) self study reports - written by the CME provider and submitted to ACCME; (2)accreditation interviews - conducted by two individuals from ACCME involving an interview ofrepresentative(s) of the CME provider; and (3) sampling of CME activities - ACCME selects asample of the CME provider's CME activities (usually 15 activities per provider) and asks theCME provider to submit a documentary file on each activity. ACCME then reviews thedocuments submitted to look for policies and procedures indicating that the CME providercomplied with ACCME policies.
Based on your response, it appears that ACCME review of CME providers reliesexclusively on information supplied by those providers. ACCME review also appears to focuson the documentation surrounding the process for funding and creating CME activities, asopposed to the substance of the activities themselves. For example, it does not appear thatACCME review involves analyzing the content of the educational activities created for accuracy,to determine whether the activities include a fair and balanced discussion of competingtherapeutic options, or whether the activities favor products manufactured by the commercialsponsor.
We understand that CME activities typically involve in-person lectures, broadcastedlectures, web-based content, self-assessment questions, and various other types of writtenmaterials. In addition to the scripted material, CME programs may involve answering questionsfrom the audience. ACCME representatives conducting re-accreditation reviews do not sit in onCME lectures, or review recordings of these lectures, to assess the speakers' core presentationsor their responses to audience questions. Similarly, ACCME representatives conductingre-accreditation reviews do not routinely assess the written materials used in CME activities forscientific accuracy or balance.
Based on your response, it appears that ACCME conducts a retrospective review thatrelies on information supplied by the CME providers, and does not involve independentinvestigation by ACCME staff or collection of information from physicians or other audiencemembers who participated in CME activities. Given the nature of ACCME review, it does notappear that ACCME would detect CME providers' voluntarily catering to their drug companysponsors by developing CME content that favorably presents the sponsors' drug products, norwould this practice necessarily violate ACCME policy. Although we suspect that the drugcompanies preferentially fund CME activities that they expect will promote sales of thecompany's products, we do not know how pervasive this is. ACCME does not collect data onwhether ACCME-accredited CME providers produce activities that disproportionately discussfavorable messages, either on-label or off-label, for products marketed by the drug companiesthat fund the activities.
ACCME uses the re-accreditation review process to determine whether the CMEprovider should retain accreditation. Your response indicates that ACCME conducts this reviewto determine whether or not a CME provider generally complies with ACCME standards, asopposed to whether an individual CME activity was conducted in compliance with ACCMEstandards. Your letter described the re-accreditation process as follows: "ACCME compliancefindings are determined at a provider level, not the activity (or presentation) level. Generallyspeaking, when the ACCME finds that 80% of activities are found 'in compliance' fromdocumentation review, then the ACCME will find the provider 'in compliance' with theaccreditation element." The Committee found this troubling, to the extent it means that a CMEprovider would be deemed to be in compliance with ACCME standards even if ACCMEdetermines that some of the provider's educational activities failed to comply with all ACCMEstandards.
Your response included results of re-accreditation reviews recently completed byACCME. You reported that ACCME has reviewed 76 accredited CME providers forcompliance with the ACCME standards for commercial support that were promulgated in 2004.
ACCME found that 18 of these CME providers were not in compliance with at least one elementof the ACCME standards. Examples from ACCME's written findings of non-complianceinclude:
-- “The provider does not ensure that decisions regarding the planning and implementationof CME activities are made independent of commercial interests. A commercial interestinfluenced where and how many presentations were scheduled for three years of a CMEactivity."
-- “The provider does not ensure that decisions regarding the planning and implementationof CME activities are made independent of commercial interests. Evidence from oneactivity reviewed indicates that a commercial interest was involved in the selection offaculty and other activities that interfered with independence."
-- “The provider does not ensure that a mechanism(s) has been implemented to identify andresolve all conflicts of interest prior to education activities being delivered to thelearner."
-- “The provider does not demonstrate appropriate management of commercial promotionassociated with educational activities. One commercially supported activity containsrecurring use of one company's product trade name at the exclusion of other products."
Your response also described the series of events that may occur if ACCME determinesthat a CME provider is not in compliance with ACCME standards. To summarize, the CMEprovider enters a multi-year corrective action process that might eventually result in losingaccreditation. You informed us that when ACCME finds that an accredited CME provider is notin compliance, the CME provider is afforded an opportunity to provide ACCME with a writtensubmission that describes the provider's compliance. The CME provider is generally allowedone year to submit this progress report to ACCME. If ACCME decides that the progress reportadequately demonstrates compliance, no further action is taken. If ACCME decides that theprogress report does not adequately demonstrate compliance, then the provider may be allowedsix additional months to submit another progress report. If that second progress report also doesnot demonstrate compliance, ACCME may put the provider on probation. If the CME providerdoes not resolve the problem after two years on probation, ACCME may rescind accreditation.
ACCME's finding of non-compliance is merely the first step down a long road to potentiallylosing accreditation, which may occur up to 3.5 years after the initial finding of non-complianceand, depending on the review cycle, as many as nine years after the problematic educationalactivities occurred.
The Committee's inquiry suggested that whether an educational program is independentis a critical feature distinguishing CME from advertising and promotion. Because drugmanufacturers cannot legally promote their products for uses that have not been approved by theFDA, it is particularly important for education programs that discuss off-label uses to beindependent. Whether a drug company is breaking the law by promoting off-label use of itsdrugs hinges on whether a CME provider independently touts an off-label use or whether thepromotion can be attributed back to the drug company.
Given the importance of the concept of independence, the Committee's request forinformation from ACCME also sought delineation of the scope of independence the CMEprovider must have in selecting the topic for a commercially-sponsored CME program.ACCME's response indicated that a commercial sponsor can designate the topic (e.g., diagnosisor treatment of a particular disease) for the CME activity, without being determined to controlcontent or otherwise violating ACCME policies. This would appear to afford drug companiessubstantial opportunity to direct their grant funding to support programs that are likely topromote sales of their products.
We do not have information about the extent to which this is the case in practice.ACCME does not keep track of how many CME programs favorably discuss a drug sold by thecommercial sponsor, either for an FDA-approved indication or for an off-label use. ACCMEdoes not gather information regarding whether the CME providers' educational activitiesfavorably discuss uses of the commercial sponsor's products in a fashion that is disproportionateto what might be expected from an independent activity that does not cater to the sponsor'scommercial interests.
Our review suggests that CME providers could say that they "control content" and have"full independence" in developing CME activities, even though they allow the commercialsponsor to influence content. The drug companies' response to our queries indicate that somecompanies' policies for funding CME allow the drug companies to offer CME providerssuggestions for CME topics and speakers. Some policies also allow the drug companies toprovide data, including data regarding off-label uses, for inclusion in CME programs, so long asthe CME provider requests this assistance. Thus, the CME provider can technically maintain"control" of content - to the extent that the commercial sponsor's suggestions are not imposed inan explicitly mandatory fashion - while continuing to accommodate suggestions from thecompanies that control their funding.
Based on our analysis of the information you provided, we find it interesting that, eventhough ACCME's reaccreditation process relies almost exclusively on information supplied bythe CME providers under review, ACCME still detects a significant number of incidences ofnoncompliance. It also appears that compliance with ACCME standards still allows CMEproviders to accommodate the business interests of their commercial sponsors and affords drugcompanies the ability to target their grant funding at programs likely to support sales of theirproducts. The full extent to which drug companies influence the content of putativelyindependent CME programs cannot be estimated from the information we currently have.
Thank you for your assistance with this matter. We greatly appreciate your cooperationwith the Committee's inquiry.
Sincerely,
Max Baucus of Montana United States Senator Chairman of the Committee on Finance
Chuck Grassley of Iowa United States Senator Ranking Member of the Committee on Finance
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April 25, 2007
NEW FINANCE COMMITTEE REPORT FOCUSES ON DRUG COMPANY GRANTS FOR MEDICAL EDUCATION
Inquiry reveals educational grants as common business practice, but potential for abuse remainsWashington, DC - Senate Finance Committee Chairman Max Baucus (D-Mont.) andRanking Republican Chuck Grassley (R-Iowa) today released results of a Committee inquiryinto drug company grants to fund continuing education for medical providers. Baucus andGrassley launched their probe following allegations that drug companies were using educationalgrants for improper purposes, such as rewarding physicians for prescribing their drugs,influencing clinical practice guidelines and Medicaid formularies, or promoting drugs for usesthat have not been approved by the FDA - an illegal practice called “off-label promotion."Guidance on keeping education programs independent of drug company influence has beenissued by numerous organizations, including the Accreditation Council for Continuing MedicalEducation (ACCME). The report includes information from ACCME suggesting that somepurportedly independent educational programs may still be influenced too much by theirpharmaceutical sponsors. It appears that ACCME’s oversight of accredited CME providers isinsufficient to guarantee the required independence.
“American taxpayers spend billions of dollars every year on drug treatments forMedicare and Medicaid patients, and those scarce dollars need to be spent wisely. Medicaleducation funded by drug companies has to be real education, not a soft sell designed to swaytreatment decisions," said Baucus. “This report shows some separation between medicaleducation and marketing efforts, but this process still isn’t clean enough. As long as drugcompanies’ medical education efforts can influence Medicare and Medicaid spending, theFinance Committee has to insist that there be more improvement."
“We need to make sure educational grants serve appropriate purposes. I take seriouslymy obligation to the taxpayers to make sure dollars for Medicare and Medicaid are spentproperly. I also take seriously my obligation to help make sure the 80 million beneficiaries ofthese programs receive appropriate care. What drugs doctors prescribe for patients, and whatdrugs federal health care dollars buy, should be made based on accurate scientific informationand what is best for that particular patient, not on improper influence from any drug maker,"Grassley said.
The full Finance Committee report is online athttp://www.finance.senate.gov/press/. The Committeecontacted 23 drug manufacturers in the course of their investigation, and all 23 cooperated fully.Drug companies reported that they continue to fund educational grants as part of a broadbusiness strategy to sell their products, but that they have set policies to distance educationalgrant funding from marketing. Committee staff concluded that the pharmaceutical industry hasfocused more on compliance with guidance for educational grants, but risks still exist forkickbacks, veiled advertising of drugs, efforts to bias clinical protocols, and off-label promotion.Baucus and Grassley said today that the Committee will follow up on its findings withparticipating drug companies and with organizations that have issued guidelines for medicaleducation grants, including the FDA, the Inspector General at the Department of Health andHuman Services, the participating drug companies, and ACCME. -------------------------------
Friday, June 10, 2005
Drug companies asked for more information about grant money awarded to promote particular medicines
WASHINGTON - Sens. Chuck Grassley and Max Baucus have asked a number of largedrug makers to explain a marketing practice where the companies give money to stategovernments and other organizations in the form of grants. The drug companies call the awards“educational grants," but the senators are concerned that the dollars are more focused on productpromotion than education.
The senators said they want to know more about the practice to ensure that it’s not just a“backdoor way to funnel money to doctors and other individuals who can influence prescribingand purchasing of particular prescription medicines, including off-label prescriptions." Theysaid their inquiry of the drug manufacturers is based on reports that some companies haveawarded these grants to health care providers as inducements to those providers to prescribemedications the companies produce. In other cases, such grants to state agencies may haveprompted those agencies to develop programs leading to over-medication of patients at theexpense of patient health or to unnecessary expense for taxpayers.
“We need to know how this behind-the-scenes funneling of money is influencingdecision makers," Grassley said. “The decisions result in the government spending billions ofdollars on drugs. The tactics look aggressive, and the response on behalf of the public needs tobe just as vigorous."
“I support drug companies giving back to the community through grants for educationalprograms used to educate state governments and health organizations about products that couldlead to improved health," Baucus said. “However, I am concerned that some grants may be forpurposes other than education. These grants need to be driven by good intentions instead ofmotivation for larger profits."
Grassley is chairman and Baucus is ranking member of the Senate Committee onFinance, which has legislative and oversight responsibility for the Medicare and Medicaidprograms. The first-ever prescription drug program within Medicare will begin in January, andfederal expenditures on prescription drugs through both Medicare and Medicaid are estimated toreach $100 billion in 2006.
The text of their letter follows here. It was sent to the following drug manufacturers:Pfizer, Inc., GlaxoSmithKline, Johnson & Johnson, Merck & Co., Inc., AstraZenecaPharmaceuticals LP, Bristol-Myers Squibb Company, Novartis Pharmaceuticals Corporation,Amgen, Inc., Wyeth Pharmaceuticals, Eli Lilly & Company, Sanofi Aventis, Eisai, Inc.,Boehringer Ingelheim Pharmaceuticals, Inc., Schering-Plough Corporation, Hoffman-LaRoche,Inc., Forest Pharmaceuticals, Inc., Abbott Laboratories, Genentech, Inc., Biogen Idec Inc.,Genzyme Corporation, Chiron Corporation, Serono, Inc., and TAP Pharmaceutical Products, Inc.
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June 9, 2005
Dear _______________:
The U.S. Senate Committee on Finance (Committee) has jurisdiction over the Medicareand Medicaid programs, and accordingly, a responsibility to oversee the proper administration ofthose programs which provide health care coverage to more than 80 million Americans. Duringthis legislative session, the Committee will continue its review of issues relating to theseprograms' coverage of prescription drug benefits, including marketing practices that could havean impact on physicians' prescribing patterns. As Chairman and Ranking Member of theCommittee, we ask that ______ cooperate with the Committee and provide it with informationregarding these matters as requested.
In recent years, the cost to Medicaid of reimbursement for prescription drugs has grown fasterthan any other area of the program. The Federal government will spend even more onprescription drugs with the addition of a prescription drug benefit to the Medicare program.Marketing practices that increase the rates at which drugs are prescribed, particularly foroff-label uses, are of concern because they have the potential to increase program costs and mayencourage the use of typically newer, more expensive drugs that have not been proven superiorto existing treatments.
The Committee has identified the use of grants, particularly educational grants, as a practice withpotential for abuse and has gathered the following background information on this topic. Theuse of educational grants was an element in a recent settlement involving off-label promotion ofa prescription drug. Also, educational grants were identified by the Department of Health andHuman Services Office of Inspector General (HHS OIG) as a key risk area in its OIGCompliance Program Guidance for Pharmaceutical Manufacturers (OIG Guidance), issued in2003. In addition, existing Federal and industry guidance is not specific about what activitieseducational grants may be used to support or what kinds of organizations may provide thoseactivities, and it appears that some manufacturers may be using educational grants to fundactivities primarily to promote their products.
Programs and materials performed and disseminated by drug companies are subject to thelabeling and advertising provisions of the Federal Food, Drug, and Cosmetic Act, and as such aresubject to regulation by the Food and Drug Administration (FDA). The FDA does not regulatetruly independent and non-promotional activities supported by industry. However, the linebetween activities performed by or on behalf of companies and activities that are independent oftheir influence has become increasingly blurred as the role of industry in supporting continuingeducation for healthcare professionals has grown. Consequently, in 1997, FDA issued Guidancefor Industry, Industry-Supported Scientific and Educational Activities. The FDA guidance lists12 factors the Agency will consider when evaluating activities and determining independence.These factors relate primarily to the independence of the provider of scientific and educationalactivities but do not explain how the Agency will determine whether an activity is educational orwho qualifies as a provider.
The OIG Guidance, likewise, does not define educational activity or provider but it does statethat support for educational activities sponsored and organized by professional organizationsraise little risk as long as the grant is not restricted with respect to content or faculty. The OIGGuidance also advises manufacturers to separate their grant-making functions from their salesand marketing functions and establish objective criteria for awarding grants that ensure that thefunded activities are bona fide.
The Pharmaceutical Research and Manufacturers of America's Code on Interactions withHealthcare Professionals (PhRMA Code) also addresses third-party educational conferences andprofessional meetings. The PhRMA Code states that support for a conference or meeting,defined as an activity "where a) the gathering is primarily dedicated to promoting objectivescientific and educational activities and discourse (one or more educational presentations shouldbe the highlight of the gathering), and b) the main incentive for bringing attendees together is tofurther their knowledge on the topic(s) being presented," is permissible. However, the PhRMACode states that such support should not be given directly to healthcare professionals but shouldbe given to a conference's sponsor, who should maintain control over the selection of content,faculty, educational methods, materials and venue.
The Committee seeks further information on this topic so that it can assess how educationalgrants are used, in what contexts and for what purposes, and who receives them. This will assistus in determining whether and to what extent educational grants are used to support activitiesthat are not sponsored or organized by professional organizations or do not involve formaleducational presentations, and whether further guidance or legislation is needed. Therefore, asChairman and Ranking Member of the Committee, we request that your company provide thefollowing information and data to the committee:
1. Identify the person(s) and/or agent(s) (including, name, title and contact information)within or affiliated with your company who is/are currently responsible for evaluating requestsfor educational grants.
2. Identify the person(s) and/or agent(s) (including, name, title and contact information)within or affiliated with your company who is/are currently responsible for approving orawarding educational grants.
3. State whether your company has a formal, written policy regarding the use of educationalgrants, or if your company relies on an unwritten policy. To the extent a written policy exists,attach copies, including all versions and revisions of the policy since its inception. To the extentan unwritten policy exists, describe it in detail, including but not limited to describing anycriteria used in evaluating, approving, awarding, authorizing, implementing and/or monitoringeducational grants.
4. Describe the factors and circumstances your company takes into account whendetermining whether or not to award an educational grant.
5. State whether your company has offered or provided educational grants to organizationsthat are not accredited by the Accreditation Council for Continuing Medical Education(ACCME) since Jan. 1, 2000. If so, please describe what other types of organizations receiveeducational grants from your company and indicate whether they are accredited by anorganization other than ACCME.
6. State whether your company has offered or awarded an educational or other grant to anystate Medicaid agencies or other state agencies, or to one or more employee/agent of a stateMedicaid agency or other state agency since Jan. 1, 2000. If so, please describe yourcompany's policy for making such grants and the factors and circumstances your company takesinto account when determining whether to award an educational or other grant to a state agencyor an employee/agent of a state agency. In addition, please describe your company's rationalefor this practice.
7. Identify the total number and dollar amount of educational or other grants your companymade to state agencies or state agency employees/agents during its fiscal years 2003 and 2004.Of those amounts, identify the total number and dollar amount of educational or other grantsawarded and list them by state, by agency, and by agency employee/agent.
8. State whether your company has offered or awarded an educational or other grant(s) as asubstitute or alternative for price concessions since Jan. 1, 2000. If so, please describe yourcompany's policy for making such grants and the factors and circumstances your company takesinto account when determining whether to award an educational or other grant as a substitute fora price concession. In addition, please describe your company's rationale for this practice.
9. Identify the total number and dollar amount of educational grants your company made inits fiscal years 2003 and 2004. Of those amounts, identify the total number and dollar amount ofeducational grants that were made to organizations accredited by ACCME.
10. In accordance with your company's response to #9 above, indicate the source of the fundsfor educational grants in your company's fiscal years 2003 and 2004. For example, if yourcompany budgets for educational grants by product line, please indicate the dollar amount ofeducational grants funded by each product line.
11. State whether your company has an annual budget for educational grants. To the extentthat your company budgets for educational grants, please identify the dollar amount budgeted foreducational grants in fiscal year 2005 by funding source.
12. State whether your company has provided educational grants for programs or activitiesthat may promote or discourage off-label use of drugs since Jan. 1, 2000. If so, pleasedescribe your company's policy for making such grants and the factors and circumstances yourcompany takes into account when determining whether to award an educational grant for anactivity that may promote or discourage off-label use of drugs.
Please provide the information and documents requested in questions 1-12 by June 30, 2005. Incomplying with this request, respond by repeating the enumerated request, followed by theaccompanying response; attach and identify all relevant documents or data by title and thenumber(s) of the enumerated request(s) to which they are responsive. Finally, in complying withthis request, please refer to the attached definitions concerning the questions set forth in thisletter.
Sincerely,
Chuck Grassley of Iowa United States Senator Chairman, Senate Committee on Finance
Max Baucus of Montana United States Senator Ranking Member, Senate Committee on Finance
