Statement of Gerald F. Meyer

Senior Consultant

AAC Consulting Group, Inc.

And

Former Deputy Director of the Center for Drug Evaluation and Research

US Food and Drug Administration

Before the

Subcommittee on Courts and Intellectual Property

Committee on the Judiciary

US House of Representatives

Washington DC

July 1, 1999

Good Afternoon Mr. Chairman.

Thank you for this opportunity to speak in support of H.R 1598, the "Patent Fairness Act of 1999."

As you may know I testified in support of this kind of legislation before this Subcommittee earlier this year, and participated in a Panel Discussion on this subject sponsored by the Intellectual Property Institute held in the Capitol on June 10, 1999.

Mr. Chairman, I have not changed my views since my previous testimony. As I stated previously, prior to enactment of the Prescription Drug User Fee Act of 1992 (PDOUFA), FDA faced enormous difficulties in reviewing new drugs within the statutory time frame because of a chronic lack of adequate funding and resources. I believe the efforts of a talented and dedicated review to carry out their responsibilities, but the Agency simply could not keep up with the number of New Drug Applications being submitted by the pharmaceutical industry.

Review and approval times increased, and it was not until enactment of the User Fee legislation that the Drug Review activities of the Agency began to receive the funds and manpower needed to reduce this extended review time. The fact is that the lack of sufficient staff before enactment of this legislation meant that when someone was ill, or otherwise unavailable to work on an application, there was no one else available to step in. And, when the number of applications in a particular drug class increased substantially, as they did for certain types of drugs at different times, that Division would simply have to defer review until they could work through this backlog. In some cases that delay could add years to review time.

It is true that the FDA assigned priorities to applications for products that represented drugs for life-threatening diseases without current adequate therapies. I agree with that priority, but I also acknowledge that it only adds to the delays for other applications that may prove to also be important over time. I say that, because as you may know Mr. Chairman, all patients do not respond equally to all products. The additional resources provided to the Drug process through user fee legislation and appropriations have been invaluable, but they have not eliminated all of the inequities that existed before this legislation, and that may somehow exist in the future. That is what I hope this new legislation will correct.

Mr. Chairman, I appreciate this opportunity to appear before your Subcommittee, and I will be pleased to respond to any questions the Members of your committee may ask.