November 10, 1999

The following letter was sent to:

• Senator James M. Jeffords, Chairman
    Senate Committee on Health, Education, Labor and Pensions
• Senator Orrin Hatch, Chairman
    Senate Committee on the Judiciary
• The Honorable Tom Bliley, Chairman
    House Committee on Commerce
• The Honorable Henry J. Hyde, Chairman
    House Committee on the Judiciary
• The Honorable Michael Bilirakis, Chairman
    House Commerce Subcommittee on Health and Environment
• The Honorable Howard Coble, Chairman
    House Judiciary Subcommittee on Courts and Intellectual Property

Dear Mr. Chairman:

We are writing concerning the General Accounting Office’s (GAO) review of the Food and Drug Administration's (FDA) approval of prescription drugs treated as 'pipeline drugs’ under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Waxman-Hatch Act.

We ask that you join our request to the GAO, in order to facilitate the FDA’s release of the pipeline drugs' New Drug Application (NDA) files in the agency’s possession to the GAO. GAO informs us that access to the NDA files is required to ensure a complete and objective evaluation. However, the FDA has informed GAO that section 301(j) of the Food, Drug and Cosmetic Act bars the agency from disclosing these files without the request of a chairman of a congressional committee or subcommittee of jurisdiction, or the consent of the pipeline drug sponsors. Without access to these files, GAO informs us, they will be unable to complete their report to Congress.

As you know, Congress is in the midst of debating legislation which could grant patent extensions to Schering-Plough and other pipeline drug sponsors, with enormous implications for consumer access to affordable medicines. While proponents of this legislation argue that the FDA was responsible for unwarranted delays in the approval of Claritin, there are strong arguments that the Claritin review was slowed by the sponsor's own conduct. Since only a comprehensive, objective GAO evaluation can answer these allegations and dispel any doubts concerning the validity of these competing claims, we hope that you will join our request out of a mutual interest in ensuring GAO has access to all of the information it requires to fulfill its congressional mandate.

We appreciate your consideration of this request and look forward to your response.

Sincerely,

Representative John D. Dingell
Representative Henry A. Waxman
Senator Patrick J. Leahy
Senator Richard J. Durbin
Senator Paul Wellstone
Senator Edward M. Kennedy
Representative Sherrod Brown
Representative Fortney Pete Stark

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