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ORPHAN DESIGNATIONS

PURSUANT TO SECTION 526

OF THE

ORPHAN DRUG ACT (P... 97-414)

Through June 30, 1984
Docket No. 84N-0102

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
Rockville MD 20867

July 30, 1984

The Honorable Robert W. Kastenmeter
Chairman, Subcommittee on Courts, Civil

Liberties, & the Administration of Justice
Committee on the Judiciary
House of Representatives
Washington, D. C. 20515
Dear Mr. Kastermeier:
This is in response to a July 25, 1984, request by Mr. Dave Beter of
your Subcommittee staff for information regarding the relationship
between patent laws and enforcement of the Federal Food, Drug, and
Cosmetic (FD&C) Act.
As you may know, in January 1979 the Food and Drug Administration
(FDA) published a proposal to amend Its public information regulations
to include a 11st of approved prescription drug products for
therapeutic equivalence. The ten "Approved prescription drug
products' refers to prescription drug products approved by FDA through
new drug applications (NDA'S) or abbreviated new drug applications
(ANDA's) under the provisions of section 505 of the FD&C Act (21 U.S.C.
355) or, in the case of antibiotics, through analogous applications,
known as Forn 5's or Form 6's under section 507 of the FD&C Act (21*
U.S.C. 357).
In response to that proposal, FDA received more than 100 comments
addressing points covered in the proposal. Among the comments was one
that stated that FDA should not evaluate as therapeutically equivalent
drug products that infringe patents because including such drugs on the
list violates constitutional prinicples as well as patent laws and
discourages discovery and disclosure of new Inventions. Another
comment said that a pharmacist relying on the list may be sued for
selling an unlicensed generic product. Therefore, the list should
mention that FDA does not consider the patent status of drugs.
After reviewing all comments, including the two mentioned above, FDA
published a Final Rule on this subject in the October 31, 1980, Federal
Register, Volume 45, No. 213, page 72582. In the preamble to that
Final Rule, FDA addressed all the conments, including the two
previously mentioned. The preamble stated that "The patent laws do not
have any bearing on the enforcement of the Federal Food, Drug, and
Cosmetic Act, and the agency does not consider these laws when

reviewing new drug applications and making drug product approval decisions. If a firm submits a new drug application for a patented drug, FDA reviews the application without considering any patent issue. If the application is approvable, it is approved. However, to inform the public of this policy the agency, as requested by the comment, will include a statement in the preface to the list to the effect that the patent status of a drug is not considered by the agency in its review of applications to market drugs." That quote appears on page 72598 of the October 31 Federal Register, a copy of mich is enclosed. This policy, as set out above, has not been revoked or modified since publication in the Federal Register.

Sincerely yours,

Robert C. Wetheren, Jr.
Associate Commissioner
for Legislation and Information

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