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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
Rockville MD 20857

August 6, 1984

The Honorable Robert W. Kastenmeier

Chairman, Subcommittee on Courts, Civil

Liberties, & the Administration of Justice
Committee on the Judiciary

House of Representatives
Washington, D. C. 20515

Dear Mr. Kastenmeier:

This is in response to an August 3, 1984, telephone request by
Mr. Dave Beier of your Subcommittee staff for information regarding
applications for products derived from biotechnology.

At the present time FDA has approved a number of applications for such
products. They are:

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In addition, there are two human biological products currently under investigational study.

With respect to veterinary drugs there are currently twelve veterinary products under investigation and one new animal drug application before the Agency for review.

The names of the manufacturers and products that are under. investigation, if not already publicly known, are considered to be trade secret and/or confidential commercial information and cannot be disclosed under the requirements of the Federal Food, Drug, and Cosmetic Act.

Sincerely yours,

Robert Walterelly

Robert C. Wetherell, Jr.
Associate Commissioner

for Legislation and Information

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To summarize briefly, our testimony raised two major concerns with respect to Title II as drafted. First, we noted that having to determine the regulatory review period for each product for which patent term extension was sought would be burdensome to FDA, and urged that instead the applicant be required to determine the regulatory review period for purposes of the patent tem extension, subject to discretionary review by this Department. Second, we also recommended that the provisions for determination of due diligence be deleted, such determination would require additional Departmental resources for no net public benefit, since we believe the overwhelming majority of applicants have in fact exercised due diligence.

We would be pleased to work with your staff to address the concerns we have with H. R. 3605.

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Mr. Chairman:

I am pleased to have this opportunity to discuss our views on

S. 2748, the "Drug Price Competition and Patent Term Restoration Act," and on draft legislation on the export of un approved drugs.

S. 2748 would revise the procedures for new drug applications by authorizing an abbreviated procedure for generic versions of "pioneer" drugs approved after 1962. It would also authorize the restoration of patent time lost due to the premarket requirements of the Federal Food, Drug, and Cosmetic (FDC) Act for drugs, medical devices, food additives and color additives.

As you know, Mr. Chairman, these concepts of an abbreviated approval process for drugs approved after 1962 and patent term restoration are initiatives given high priority by this Administration. We firmly believe that establishing an abbreviated new drug application (ANDA) system is a public health objective whose time has come. As more and more drugs from the post-1962 era come off patent, an ANDA system for these drugs would increase competition, lower drug costs and save American consumers literally hundreds of millions of dollars in the years ahead. And, by preserving incentives for drug development, the companion provision for patent term extension is also in the public interest. Accordingly, we support the concepts in S. 2748 and believe that, with certain technical revisions, the bill would represent a major advance in our nation's health care system.

Let me provide some additional background before I turn to the bill

itself.

ANDAS

An ANDA is an abbreviated new drug application for marketing approval for a duplicate version of a drug product that has been approved as safe and effective. An ANDA does not contain the clinical data on human safety and efficacy that were required in the new drug application (NDA) to market the previously approved or "pioneer" drug. It is predicated on the view that the safety and effectiveness of the therapeutic entity have been established.

To require repetition of the costly studies originally needed to establish safety and effectiveness has the effect of barring the introduction of most generic equivalents. Without an ANDA procedure, the requirement for NDAs has the effect of a secondary patent which protects the pioneer indefinitely from generic competition. Moreover, a requirement for duplicative clinical studies is scientifically unnecessary.

The Food and Drug Administration (FDA) has long recognized the value of an ANDA system. ANDAs have been used by FDA under the Drug Efficacy Study Implementation (DESI) program for the approval of generic versions of drugs first approved only for safety between 1938 and 1962, the year in which Congress amended the FDC Act to require that drugs be shown to be effective as well as safe. A similar procedure has not been established for post-1962 drugs. In recent years, however, the patents have expired for many post-1962 drugs. As a result, generic drug manufacturers have become increasingly interested in changing FDA's drug approval system to eliminate the current requirement for the

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