Prescription Drug User Fee Act

Floor Speech

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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