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“HEALTH CARE” mentioning the U.S. Dept. of Justice was published in the Senate section on pages S5433 on May 18, 2005.
The publication is reproduced in full below:
HEALTH CARE
Mr. SANTORUM. Mr. President, at a time when the importance of the U.S. Food and Drug Administration is highlighted by concerns over the safety of pharmaceuticals, it would be foolish to move forward with importation policies that would circumvent the safety regulations of the FDA. I want to take this opportunity to highlight a recent international Internet pharma-trafficking network that was shut down in Philadelphia, which I strongly believe provides a very accurate, and disturbing, window on what exactly a prescription drug importation scheme would mean for Americans.
On April 20, 2005, the Department of Justice announced the unsealing of an indictment returned by a Federal grand jury on April 6, 2005. The indictment chronicled how the ``Bansal Organization'' used the Internet to fill orders for pharmaceuticals. In turn, this crime ring facilitated millions of un-prescribed pills coming into the United States--of which the bio-efficacy and the safety have yet to be determined--to consumers who only needed a credit card. These drugs included potentially dangerous narcotics, such as codine and Valium, drugs that can cause serious harm if not taken under a physician's supervision, and which have been highlighted repeatedly as drugs that pose special concerns as we debate possible importation.
Stretching from America to countries such as India, Antigua, and Singapore, officials estimate that this international conspiracy provided $20 million worth of un-prescribed drugs to hundreds of thousands of people worldwide--most if not all of whom had no idea where their drugs originated. This drug scam exemplifies how the Internet can be a door to an unregulated world of just about any kind of pharmaceutical--including counterfeits and potentially dangerous narcotics. This is particularly concerning given the growing ease at which prescription drugs can be purchased over the Internet.
At the heart of the debate on foreign importation of prescription drugs is the concern over the cost of prescription drugs. Often proponents claim that importation would allow Americans access to other countries' drugs at a cheaper price, despite thorough analysis by the U.S. Health and Human Services Task Force on Prescription Drug Importation. The HHS Task Force reported that any associated cost savings with importation would be negated by the costs associated with constructing and attempting to safely maintain such a system, and ultimately concluded what both past and current Administrations have found: the safety of imported drugs purchased by individuals, via the Internet or other means, cannot be guaranteed. Moreover, generic prescription drugs in America are on average 50 percent less than their foreign counterparts. This holds true in the case of the ``Bansal Organization,'' in which the vast majority of the trafficked drugs were sold at prices higher than what a consumer would have paid at a legitimate pharmacy. The safety of the American drug supply should not be sacrificed for supposed savings. Those that continue to purport that importation would provide cheaper drugs are misleading the American people, and as a result putting their health and lives at risk.
Importation will not equate to cheaper drugs for Americans, but it will lead to an explosion of opportunities for counterfeiters to take advantage of the American people by compromising the safety of our drug supply. Many individuals, both patients and healthcare professionals, who testified during the HHS Task Force's proceedings expressed significant concerns that importation would compromise the integrity of the American drug supply by creating a vehicle through which terrorists could easily introduce harmful agents in the United States. Recall that in 1982, seven Americans died after ingesting Tylenol laced with cyanide. More recently, in July 2003 members of a Florida-based drug-
counterfeiting ring who sold and diluted counterfeited drugs were indicted, and 18 million tablets of counterfeit Lipitor were recalled after evidence revealed that this popular anti-cholesterol drug had been manufactured overseas and repackaged in the United States to hide the deception. Importation would provide for any of these acts to be committed on a larger, exponentially more devastating, national scale. To put this in perspective, in 2003, 69 million prescriptions were written for Lipitor in the United States alone.
The ``Bansal Organization'' bust is but the latest in a series of illicit pharmaceutical trafficking scams, which are extremely lucrative, and which our law enforcement officials are already struggling to combat on a daily basis. Why would we elect to open the door to importation when we know that doing so will create infinite opportunities to compromise the safety of our drug supply?
As we continue to debate the best ways to ensure that Americans have access to the highest quality, affordable prescription drugs, I would caution my colleagues that importation is not the answer. It would be unconscionable to facilitate in any way the dangerous shortcuts utilized in the Philadelphia drug scam--shortcuts that circumvent the essential ongoing patient relationship with physicians and other licensed professionals trained to monitor potential medication interactions and side effects that can lead to serious injury and/or death.
Congress should uphold the strong regulatory standards on drug safety that exist today, and not open our borders to prescription drugs from a world of unknown sources.
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