[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 11358-11359]
[From the U.S. Government Publishing Office, www.gpo.gov]




                   IMPORTATION OF PRESCRIPTION DRUGS

  Ms. SNOWE. Mr. President, I thank the Senator from Massachusetts for 
his courtesy and for his cosponsorship of this initiative. I, 
obviously, want to also thank the sponsor of this legislation, with 
whom I am privileged to join, the Senator from North Dakota, who has 
demonstrated leadership for the last decade on this initiative which is 
so crucial to the American consumer.
  I rise to speak today on behalf of the Dorgan-Snowe amendment 
regarding drug importation. I know the Senator from Mississippi, Mr. 
Cochran, has offered a second-degree amendment to require the Secretary 
of Health and Human Services certify both the savings and safety of 
drug importation. Obviously, there is concern for the safety of the 
American people. It is one that I appreciate strongly. It must be our 
highest priority. But we have been at this juncture before with respect 
to drug importation.
  As I mentioned earlier, twice before we have seen the Congress adopt 
a requirement for the Secretary to certify safety and savings before 
implementing a program of prescription drug importation, and not a 
single prescription drug was imported under either the MEDS Act of 2000 
or the Medicare Modernization Act of 2003. Americans deserve access to 
affordable medications, and that access must be safe, but it is not 
made so by simply certifying with respect to drug importation. As I 
said, twice before we have been through this--in 2000, and of course in 
the Medicare Modernization Act of 2003 under the prescription drug 
benefit for the Part D Program.

[[Page 11359]]

  Many who are in the Senate today supported a certification 
requirement in good faith, recognizing that the Secretary of Health and 
Human Services would certify the safety upon reviewing and evaluating 
circumstances, but that has not occurred. Most would not think such a 
certification would block Americans from legally importing medications. 
That is because for years we have seen our constituents--and certainly 
those from my State of Maine--using Canadian pharmacies, and both the 
safety and savings were indisputable. Yet certification did not arrive.
  As a result, the former Secretary of Health and Human Services, 
Secretary Shalala, declined to make the certification with respect to 
the MEDS Act, and we know she did so because of three specific flaws in 
the law, each of which this legislation addresses.
  After the passage of the Medicare Modernization Act, which included 
the prescription drug program, we saw that former Secretary Thompson 
could not certify importation. The fact is, it is patently unfair to 
ask the Secretary to make such a certification, especially as to 
safety. That is because you must give the Secretary the resources and 
the authority to implement measures to make prescription drugs and 
their distribution as safe as possible.
  So it comes as no surprise that given no standards, no authority, and 
no resources, we have failed to see a Secretary provide certification 
over the last 7 years. Secretary Thompson understood this well. He said 
it simply:

       The law is this: In order to import drugs from any country, 
     and especially Canada, I have to certify that all those drugs 
     are safe. That is an impossible thing. If Congress wants to 
     import drugs, they should take that provision out.

  The certification of savings is no less of a red herring. In fact, it 
has become a persistent roadblock every time we have passed 
certification to allow drug importation by the Secretary of Health and 
Human Services. Without a doubt, Americans would not purchase imported 
medications if substantial savings were not being realized. Indeed, the 
Congressional Budget Office has told us the countries from which we 
would import under this bill pay 35 to 55 percent less for brand 
prescription drugs and that we can realize a drug savings alone of $50 
billion over 10 years. It should be patently obvious the savings part 
of certifying importation is a nonissue.
  In fact, the Congressional Budget Office has confirmed those savings 
again, estimating that in addition to consumer savings, the Federal 
Government would save $10.6 billion--including the Medicare and 
Medicaid Programs that would achieve indisputable savings. Every cent 
of that savings, the CBO estimates, will be lost if the Cochran 
amendment is adopted because, as we all know, there would be no legal 
importation.
  The savings are clear. Yet the advocates of certification continue to 
insist certification is critical--particularly regarding safety. Yet 
what is needed is not a certification requirement, which simply is a 
stamp on the status quo, but real action to assure the safety of 
prescription drugs.
  By way of analogy, I would like to know where we would be if we 
applied this simple certification approach to other areas. Consider air 
travel. Americans embark on thousands of flights every day, but the 
travel of millions is not dependent on certifying the status quo. We 
rely on regulation and oversight of the aircraft that fly and their 
maintenance--of the individuals who crew, service, and direct those 
aircraft--of every critical aspect of aviation. If we were waiting for 
the FAA and its international partners to simply say flying is safe 
rather than acting to make it safe, we simply wouldn't have commercial 
air travel.
  I note that last week, as the Senate discussed problems with both the 
drug and food safety, I did not hear my colleagues suggest FDA certify 
that imported food is safe. We, instead, spoke about measures to make 
it so. That points to what this amendment is about--not ensuring safety 
but blocking fair access to imports for Americans.
  The fact is, Americans simply cannot see why it is that they cannot 
be provided a safe and effective system, which is exactly what the 
Dorgan-Snowe amendment does and what this legislation has been drafted 
to accomplish year in and year out. We have taken every conceivable 
concern regarding safety and incorporated it in this legislation.
  As you can see on this chart, we incorporate 31 provisions. Compare 
that to the Medicare Modernization Act, which included the Part D 
prescription drug program for seniors, that included only six safety-
related provisions. We included 31 different provisions. That is 
crucial to understanding that this sets up a system that will allow FDA 
inspectors to approve registered prescription drugs imported from other 
countries--in fact, countries that meet or exceed our standards. 
Compare that, for example, to the fact that the FDA approves 
manufacturing facilities in other countries that actually have lower 
standards than our country does. We allow medications to be 
manufactured in other countries with lower standards than what we have. 
Yet we are now saying we will not allow importations of medications 
from countries that meet or exceed our standards.
  At a time in which American consumers are paying 35 to 55 percent 
more for drugs than foreign consumers--in fact, paying the highest 
prices in the world--this amounts to $99 billion more than the foreign 
consumers. That is what Americans pay today. Some would say: Oh, that 
affects research and development. Well, no, not exactly. In fact, the 
pharmaceutical industry spends about 10 percent of that $99 billion. So 
about $10 billion in research and development more than they do in 
Europe. So we are not seeing the increase in prices that Americans pay 
being channeled into more research and development. It simply is not 
the case.
  What this does say is that American consumers are paying more than 
anyone else in the world. Not only are they paying more for their 
drugs, but American taxpayers are underwriting the research and 
development, as we have seen obviously with the National Institutes of 
Health. The taxpayer understands how important it is that the Federal 
Government remain on the vanguard of research and development of life-
threatening medications, and not only are they paying for the research 
and development that benefits foreign consumers, who are paying 35 to 
55 percent less, but they are also paying the highest prices in the 
world.
  That is why this legislation allowing for drug importation is so 
essential. We have addressed every safety concern. We create a regime 
for tracking the shipments, creating a pedigree, creating a history 
with FDA approval--inspected and registered. So I would urge the 
Members of the Senate to defeat this certification amendment and to 
support the Dorgan-Snowe amendment. I think we have achieved a 
milestone moment in the Senate, where we have finally recognized and 
acknowledged that the day has come to allow Americans to take advantage 
of more competitive prices than have been available to them before.
  I yield the floor.

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