[Congressional Record (Bound Edition), Volume 151 (2005), Part 7]
[Senate]
[Page 10112]
[From the U.S. Government Publishing Office, www.gpo.gov]




                              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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