New Commission to Study 'Drug Lag' ReformAuthor(s): Carol LevineSource: IRB: Ethics and Human Research, Vol. 3, No. 7 (Aug. - Sep., 1981), p. 11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3563863 .

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August/September 1981

to subjects--that has come to occupy the attention of the policy process.

In short, it is a serious misconception to think ethical review applies only to research subjects and not to persons burdened by legislative, judicial, or ad- ministrative action. They too deserve and in fact, receive ethical review-a review built into the very structure of the governing process. But research subjects who fall outside the protection of these mechanisms also deserve pro- tection. Their need is not the most im- portant problem in the world, but once we are aware of it, it is not paradoxical to develop a human subject policy be- fore resolving all the world's ills.

John A. Robertson Professor of Law University of Wisconsin-Madison

UPDATE

New Commission to Study 'Drug Lag' Reform

A newly appointed Commission on the Federal Drug Approval Process has begun studying the current seven- to ten-year drug lag between the discov- ery of new pharmaceuticals and their approval by the FDA. The commission, which was established through the efforts of Reps. James H. Scheuer (D.- N.Y.) and Albert Gore (D.-Tenn.), will focus on two primary tasks:

1. To make recommendations on how the FDA's procedures for the ap- proval of new drugs can be expedited without compromising public safety;

2. To make recommendations on the development of cost-effective post-mar- keting surveillance processes that can guarantee the quick withdrawal from the marketplace of drugs that cause significant adverse effects.

The commission is chaired by Dr. F. Gilbert McMahon of the Tulane Uni- versity School of Medicine; Dr. Robert J. Levine of Yale University School of Medicine is vice-chairman. The 25 members include experts on drugs and the pharmaceutical industry from uni- versities, the government, and the pri- vate sector.

At the opening session, held on July 21 in Washington, Rep. Scheuer stated that he hoped the commission would complete its work by January 1, 1982, but that it was more likely that its final report would be sent to the Reagan Ad- ministration in February.

Carol Levine

a LNOTATIONS Ajayi, O. O. "Taboos and Clinical Re- search in West Africa." JOURNAL OF MEDICAL ETHICS 6 (June 1980), 61-63 [0.0. Ajayi, Department of Surgery, University College Hospital, Ibadan, Nigeria].

Ajayi says cultural demands and so- cial taboos must be taken into account if ethical standards in research are to be maintained. To protect the rights of individuals the author proposes a sys- tem of review that includes a National Committee (to determine the relevance of the proposed study to the nation as a whole), a Peer Review Committee (to ensure ethical principles in relation to local social milieu), and subcommit- tees of researchers and technicians (to ensure sound, scientific, safe experi- mentation). IRB COMPLIANCE ACTIVITY WORK- SHOP. Transcript of meeting held at Department of Health & Human Serv- ices, November 7, 1980 [Dr. J. Petric- ciani, Director, Bioresearch Monitor- ing Program, FDA, 8800 Rockville Pike, Bethesda, MD 20205 1.

The workshop discussed the positive and negative aspects of the FDA pro-

gram of IRB compliance assessment and attempted to develop a dialogue between the FDA and the IRB commu- nity. Panelists suggested possible alter- native IRB inspection systems and focused on areas where the FDA might improve the current program. The panel, moderated by Mark Novitch, in- cluded Frederick A. Clark, Jr., John F. Horty, Robert J. Levine, Kenneth W. Sloan, Paul F. Wehrle, and Herman S. Wigodsky.

Mosteller, Frederick. "Innovation and Evaluation." SCIENCE 211 (February 27, 1981), 881-86 [F. Mosteller, Depart- ment of Biostatistics, School of Public Health, Harvard University, Boston, MA 02115 ].

In his address to the annual AAAS meeting in Toronto in January 1981, Mosteller discussed social, medical, and technological innovations and the need for such innovations to be evalu- ated. He illustrated the need for (1) a reduction in the time evaluations take; (2) data linkage for the gathering of in- formation; and (3) research on the re- search process itself in both basic science and technology.

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