March 6, 2002

Mr. Chairman, thank you for scheduling today’s hearing. Soon we will consider for the third time legislation to provide user fees for prescription drug approvals. I have supported user fees from the beginning, and continue to do so. I will repeat here what I said on the floor of the House in November 1997 when we passed the current user fee: "These user fees, and FDA’s own commitment to excellence, help make this agency the finest of its kind in the world."

But this program can be improved. I join my colleagues, Representatives Stupak and Brown, in their desire to improve the current program’s post market safety features. More drugs than ever are first launched in the United States. Modern marketing and advertising practices result in more consumers using more drugs in a shorter period of time after FDA approval than ever before. Our population is more diverse than ever. Diseases and drug therapies to treat them present new challenges. These factors argue in favor of an enhanced post market surveillance system that tracks drugs after they have been approved so that we know drugs are safe and effective in the real world and not just at the moment they leave FDA’s door after clinical trials. I know that we will hear encouraging testimony about improvement in this area. The legislative text, plus any related side agreements, will need to implement safety improvements.

Also, concerns have been raised about PDUFA’s role in the drug review process, so I look forward to today’s testimony on these as well. Mr. Chairman, I ask unanimous consent to have included in the record the Patient and Consumer Coalition’s PDUFA paper, which outlines many of these concerns. This coalition includes many consumer advocates, patient groups, including the International Union, and UAW. I further request that Dr. Crawford review this paper and provide us with a response or comment to the points and concerns raised in that document.

Finally, I want to echo the request of our Ranking Member, Mr. Brown, that this Subcommittee consider drug price and access issues this year. While I support the effort to produce a bipartisan PDUFA bill, we all know that there is a great deal of interest in these other issues, and we must begin to address them.