[Congressional Record (Bound Edition), Volume 153 (2007), Part 14]
[House]
[Page 19843]
[From the U.S. Government Publishing Office, www.gpo.gov]




                     PRESCRIPTION DRUG USER FEE ACT

  The SPEAKER pro tempore. Under a previous order of the House, the 
gentlewoman from Connecticut (Ms. DeLauro) is recognized for 5 minutes.
  Ms. DeLAURO. Mr. Speaker, I rise to address the Prescription Drug 
User Fee Act, better known as PDUFA, and to express my concern about 
the path this Congress took to reauthorize it for the next 5 years.
  As we all know, this is an important law affecting millions of 
Americans and their health every day. We have an obligation to examine 
it closely and debate it in great depth. Yet, by considering the bill 
under suspension, this Congress has neither explored nor understood its 
full ramifications.
  As we move ahead with PDUFA, this reauthorization clearly offers 
powerful reforms and poses still greater challenges. There is a lot to 
be proud of in the bill, adding new transparency, providing new 
resources to ensure the safety of the drugs and devices that we count 
on every day to fight disease and to stay healthy.
  To be sure, it is certainly stronger than the bill that passed on the 
Senate side, and that is a good thing. This bill expands the FDA's 
ability to monitor the safety of drugs and medical devices after they 
have been approved and marketed, and increasing by $225 million over 5 
years the user fees the agency can use for post-market safety 
monitoring. The FDA would be required to revisit the drug several years 
later for further analysis. And for riskier drugs, there would be 
regulation limiting prescribing authority to trained physicians.
  In addition, by providing funds for the active analysis of large 
medical databases, this bill will also help us quickly detect drugs 
with major short and long-term safety problems. However, there are 
significant improvements we could have made to the bill if it were 
taken up under regular order and amendments were debated.
  This bill, for example, does not provide any mandatory recall 
authority for the FDA to immediately pull products off the shelves 
after they have been found to be dangerous. I do not need to remind my 
colleagues that many of the high-profile drugs recently taken off the 
market had to be removed voluntarily, and that was only after 
significant damage had already been done.
  So Mr. Speaker, I ask my colleagues to look at this bill a little 
closer. You will get an idea of just how much influence the drug 
industry has on this Congress.
  Indeed, there were a number of very strong provisions in the original 
subcommittee draft bill that were unjustifiably weakened during the 
markup process. For instance, this bill creates a new risk evaluation 
and mitigation strategy for new drugs that would create specific 
requirements and criteria for each drug. Under the original draft, drug 
or device companies would have been subjected to a $20 million maximum 
fine for a single violation, and a $100 million maximum fine for 
several violations. These figures were reduced, however, to $250,000 
and $1 million as the bill moved forward. As you know, this is mere 
pocket change for drug companies, and provides virtually no deterrent 
to companies that choose to ignore the new process.
  In addition, the original draft would have granted the FDA discretion 
to ban direct consumer advertising for a new drug for up to 3 years, 
yet this provision was weakened as well, making it completely 
voluntary, while giving the FDA zero authority to require changes.
  Worse still, if a drug company chooses to volunteer for the review 
system and pays a fee, it can run its advertisements regardless, 
rendering the system utterly useless.
  And finally, when it comes to addressing significant conflicts of 
interest at the FDA, the language here is actually weaker than what the 
FDA itself proposed earlier this year. The agency, in fact, would have 
prevented any Members with conflicts of interest from voting on an 
advisory panel, and would have prevented any Member with more than 
$5,000 worth of investments from even serving on the panel. This bill, 
however, allows the FDA to grant waivers overriding its already lenient 
current conflict-of-interest rules.
  Today the pharmaceutical industry argues that interaction between 
drug companies and doctors who serve on these advisory committees are 
beneficial. Well, we know it is beneficial to the drug companies. It is 
time to end the influence drug companies have in our doctors' offices 
and at the FDA.
  By providing additional resources and boosting the FDA's post-market 
surveillance activity, this bill takes us in the right direction. But 
we got here the wrong way, under suspension of the rules. As a result, 
with no debate and no amendments, the final legislation serves the 
American people poorly.
  It is no surprise that drug companies are always working to improve 
their bottom line. They are big businesses with stockholders to please. 
But we have an even bigger responsibility to meet. We have a tremendous 
obligation to protect the public health and to ensure a safe America 
for everyone.

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