Statements and Speeches

Hearing on Reauthorization of the Prescription Drug User Fee Act
March 6, 2002

Opening Statement of Henry A. Waxman

The Prescription Drug User Fee Act has achieved its primary goal - - to speed the review of new drugs in the US. New drugs are now available in the US as fast or faster than anywhere else in the world. This is an important achievement. We should make every effort to ensure that people have access to safe and effective new medicines as quickly as possible.

This achievement has come at a cost, however.

That cost is an underfunded drug review staff working on too many drugs in too little time. Even FDA has called the working environment there a "sweatshop." Hours are long, salaries and training opportunities are poor, and turn-over is high. Under those conditions, it is difficult to have complete confidence in the approval decisions they reach.

Speeding drug approvals has had another cost as well. It has siphoned off essential funds for post-market safety programs, for review of direct-to-consumer ads, and for generic drug approvals. All of these FDA programs are critical to ensuring that drugs are safe and affordable, and all are severely underfunded.

Most importantly, the cost of faster approvals has been a loss of public confidence in the safety of new drugs.

As this has been happening, we have witnessed a large increase in direct-to-consumer advertising of prescription drugs - - ads that were not permitted at the time PDUFA was first enacted. It has been demonstrated that these ads are extremely successful at fueling both demand by consumers and prescribing by physicians.

At the same time, many believe that these ads are often misleading and unbalanced. Whatever your view of whether these ads should be allowed (and frankly I don't believe they should), most of us would agree that we should have a system that ensures that direct-to-consumer drug ads are accurate and fair. We do not have such a system. Right now, FDA has only 13 staff to review over 37,000 pieces of prescription drug advertising each year.

Speeding the review of new drugs is important. But ensuring the public that drugs are safe and effective demands more. We cannot sacrifice safety for speed. And we must be vigilant in our oversight of prescription drug ads to be sure that misleading ads do not prompt unsafe or inappropriate use of drugs.

User fees paid by the pharmaceutical company have provided the means to turn a slow approval process into one of the fastest in the world. And they could provide the means to build a program that provides assurance to the public that new drugs are safe and effective, and that their advertising is truthful.

Until now, the pharmaceutical industry has resisted paying user fees for any purpose other than speeding approvals.

They have fought proposals to use their fees to ensure that the safety and effectiveness of their drugs is monitored and validated after approval.

They have been unwilling to allow their fees to be used to ensure that their advertising is fair and truthful.

I believe that the industry has been short-sighted. It is in the interest of manufacturers to support programs that give Americans confidence that prescription drugs can be safely used as advertised.

This week we learned that the industry has agreed to pay increased fees to adequately fund the premarket review of drugs and a small amount to support a post-market safety program. I applaud this beginning. But much more is needed.

Right now, the pharmaceutical industry spends one tenth of one percent of its revenues on user fees. Meanwhile, faster approvals have saved the industry billions of dollars per year. I don't think it's too much to ask that the industry pay what is necessary to ensure the safety and effectiveness of their drugs before and after approval. I don't think it's too much to ask that the industry help FDA ensure that direct-to-consumer ads are accurate and balanced. Continued public confidence in prescription drugs is in the balance.

While I have concerns about some of the details of this reauthorization, I believe that good progress is being made and I look forward to working with my colleagues on both sides of the aisle on this important legislation.

In closing, let me note that today's hearing covers only one of the prescription drug issues confronting us. The most critical of these is the high price of prescription drugs - - causing hardship to the poor and to our seniors and driving up the cost of health care for all of us. Adding to the crisis in affordability, we know that there have been serious abuses of the Waxman-Hatch Amendments by brand-name manufacturers trying to keep generic drugs off the market. We owe it to the public that this Committee address these issues. I look forward to working with my colleagues on the Committee to solve these pressing problems.