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determine whether a much broader indication should later be

approved.

In all other instances of which I

am aware, Phase

IV studies have been required to justify an already-approved

indication, not a potential future indication.

Second, it is the only drug subject to a required

Phase IV study that was imposed under one set of regulatory

expectations, two years before the 1984 Act was even intro

duced in Congress, and that will be completed under an

entirely different set of regulatory rules, three years after

the 1984 Act was in fact enacted.

I have discussed this with

representatives of EDA, who can think of no other Phase IV

requirement that has similarly spanned enactment of the 1984

statute.

Third, the Helsinki Heart Study has been the largest

Phase IV study ever required by FDA.

It has involved some

4,000 patients and about 27 million dollars, and has taken

some eight years to plan and execute.

Fourth, a large part of the reason for the Helsinki

Heart Study is to investigate the validity of the hypothesis that raising HDL (the good cholesterol) does in fact reduce morbidity or mortality. If this hypothesis is supported, it

is likely that FDA will in the future approve claims for

reduction of heart disease risk based solely upon physiological

evidence that the drug raises HDL, without requiring addi

tional evidence that in fact this reduces morbidity and

mortality.

Thus, the Helsinki Heart Study represents ground

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breaking fundamental medical research on which the future of

an entire new class of drugs and the health of hundreds of

millions of people throughout the world rests.

Each one of these four factors should be sufficient,

in itself, to demonstrate the unique status of Lopid. Taken together, they provide overwhelming justification for a five

year statutory extension of the Lopid patent.

VI.

Conclusion.

The circumstances surrounding the Lopid approval,

and the subsequent Helsinki Heart Study, were not considered

when Congress enacted the 1984 Act.

It was premature to take

these unique circumstances into account at that time because

the Helsinki Heart Study had not yet been completed and the

ultimate outcome could not be foreseen.

Now that all indica

tions are that the study has been successfully completed,

legislation to extend the Lopid patent for five years should

be enacted.

PETER BARTON HUTT

Mr. Hutt is a partner in the Washington, D.C. law firm of Covington & Burling, specializing in food and drug law and in government regulation of health and safety.

Mr. Hutt began his practice of law with Covington & Burling in
October 1960, becoming a partner in 1968. From 1971 to 1975
he was Chief Counsel for the Food and Drug Administration. In
September 1975 he returned to private law practice with
Covington & Burling.

He is a graduate of Phillips Exeter Academy; received his B.A., magna cum laude, from Yale University; his LL.B. from Harvard University; and his LL.M. from New York University under a fellowship from the Food and Drug Law Institute. He is a member of the New York, District of Columbia, and Supreme Court Bars.

Mr. Hutt's current activities include membership in the
Institute of Medicine, National Academy of Sciences; the
Advisory Board, Center for Study of Drug Development, Depart-
ment of Pharmacology and Toxicology, Tufts University; the
Advisory Board, Scripps Clinic and Research Foundation, La
Jolla, California; the Board of Directors, Legal Action
Center, New York City; the Executive Committee, Washington
Lawyers Committee for Civil Rights Under Law; the Advisory
Board of the Institute for Health Policy Analysis, Georgetown
University; the Advisory Board of the University of Virginia
Center for Advanced Studies; the Board of Directors of the
Foundation for Biomedical Research; the Board of Councilors of
the Society for Risk Analysis; the Institute of Medicine
Committee on the Role of the Physician in Occupational and
Environmental Medicine ; and the National Academy of Sciences
Committee on Risk Perception and Communication. Mr a Hutt has
coauthored (with Richard Merrill) a legal casebook on Food and
Drug Law: Cases and Materials (Foundation Press, 1980). He
serves on the editorial boards of Eood Drug Cosmetic Law
Journal, Regulatory Toxicology and Pharmacology, Biotechnology
Law Report, HealthSpan, and the Journal of Clinical Research
and Drug Development.

During his service as Chief Counsel for EDA, Mr. Hutt was instrumental in establishing the OTC drug review and the biological drugs review and in shaping the drug efficacy study implementation (DESI) program for prel962 new drugs. He took a leading role in the development of a comprehensive revision of food labeling requirements and the modernization of food standards. He prepared the first federal regulations adopting quantitative risk assessment in regulating carcinogens, establishing safe levels for secondary carcinogens, and controlling environmental carcinogens. He also participated

(over)

in drafting the Drug Listing Act of 1972, the Consumer Product Safety Act of 1972, and the Medical Device Amendments of 1976. He imposed the first requirement for preambles explaining government regulations, and just before leaving government service he prepared comprehensive regulations governing all aspects of EDA administrative practices and procedures. During the 1960s Mr. Hutt litigated several cases designed to require the handling of alcohol and drug abuse as a public health problem rather than under the criminal law and drafted the legislation which created the National Institute of Drug Abuse. He serves today as General Counsel of the Alcoholic Beverage Medical Research Foundation.

From 1976 to 1980 he was a member of the NAS Committee on Research Training in the Biomedical and Behavioral Sciences. During 1976-1978 he served on the NIH Advisory Committee to Review the Guidelines for Recombinant DNA Research, during 1978-1981 he was a member of the Advisory Committee to the Director of NIH, and during 1981-1982 he was a member of the NIH Task Force on Cooperative Research Relationships with Industry. He has served on the advisory panels of five Office of Technology Assessment studies and as a consultant to three other OTA studies. During 1980-1986 he served on the Visiting Committee, School of Public Health, Harvard University. He was a member of the Pharmaceutical Panel of the Committee on Technology and International Economic Trade Issues, National Academy of Engineering. He has served as Chairman of the Life Sciences Committee of the American Bar Association ́s Section of Science and Technology.

Mr. Hutt is listed in who's Who in America, Who's Who in
American Law, Who's Who in Health Care, and Who's Who in
Washington, D.C.

7/87

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Royal Society of Medicine Services Limited

International Congress and Symposium Series

Editor-in-Chief: H. J. C. L'Etang

Number 87

Further progress with gemfibrozil

Collected papers sponsored by the Meilahti Foundation, Helsinki, Finland

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