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This is in response to an August 3, 1984, telephone request by
Mr. Dave Beter of your Subcommittee staff for Information regarding
applications for products der ived from biotechnology.
At the present time FDA has approved a number of applications for such
products. They are:
Manufacturer

Product
Centocor, Inc

Antibody to HBsAg
Gamma Biologicals, Inc. Blood Grouping Serum Anti-M
Ortho Diagnostics, Inc. Anti-Human Serum - Anti-c3d
Ortho Diagnostics, Inc. Anti-Human Serum - Ant 1-c3b, -C3d
Ortho Diagnostics, Inc. Anti-Human Serum
Chead fomed, Ltd.

Blood Grouping Serun -
Antt - A, Anti - B, Antt - Led,
Anti - Leb

E11 Lilly

Humulin (insulin)
E11 Lilly

Humulin R (insulin)
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 confident tal commercial Information and cannot be
disclosed under the requirements of the Federal Food, Drug, and
Cosmetic Act.

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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 term 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.

Sincerely,

bynther Port

Z

hthia C. Root
Deputy Assistant Secretary
for Legislation (Hoalth)

Enclosure

СС

Rep. Kastermeier
Rep. Pish
Rep. Moorhead

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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 in 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. Chaiman, these concepts of an abbreviated approval

process for drugs approved after 1962 and patent term restoration are

initiatives given high or iority by this Administration. We fimply

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

Amer ic an 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 prolide 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

ther apeutic entity have been estab 11 shed.

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 gener ic verstons 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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