The FDA's New SheriffAuthor(s): Tabitha M. PowledgeSource: IRB: Ethics and Human Research, Vol. 14, No. 1 (Jan. - Feb., 1992), pp. 10-11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3563774 .

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for human subject research out- lined by the National Commission and successfully deals with the special circumstances surrounding HIV research in a federal military institution.

Acknowledgments The opinions or assertions contained herein are the private ones of the authors and are not to be construed as official or reflecting the views of the Department of Defense, Department of the Army, or the Uniformed Services University of the Health Sciences.

References

1. Curran, WJ: AIDS research and "the win- dow of opportunity."NEM 1985; 312: 903-904; Gostin, U), Curran, W, and Clark, ME: The case against compulsory caselinding in controlling AIDS: Testing, screening and reporting. Amerian Jour- nal ofLaw andMedicine 1987; 12:7-53.

2. The National Commission for the Protec- tion of Human Sukjects of Biomedical and Behavioral Researci The Bebront Report EcalPincples and Guidelines for the Proteion ofHuman Subjects ofRe- search.DHEW Publication No. (OS) 78- 0012. Washington, DC: U.S. Government Printing Office, 1978.

3. Levine, RJ, and Lebacqz, K Some ethical considerations in clinical trials. Clinical th1maaogy and Thewpeuacs 1970; 25:72841.

4. Arras, JD: Noncompliance in AIDS re- search. Hastgs CenterReport 1990; 20(5): 24-32.

5. Committee for the Protection of Human Participants in Researcx A P. A. Ethical issues in psychological research on AIDS. IRB 1986; 8(4): 8-10.

6. Fletcher,JC, Donmel FW, Jr., andxCowll DD: A trial poicy for the intamural programs of the National Institutes of Health Consent to research with impaired human subjects. IRB 1985; 7(6): 1-6.

7. Lackey, DP A single subject in multiple protocols: Is the risk equitable? IRB 1986; 8(1): 8-10.

8. Robertson, JA Taking consent seriously. IRB intervention in the consent process. MRB 1982; 4(5): 1-5.

9. Blendon, RJ, and Donelan, K Discrimina- tion against people with AIDS: The public's perspective. NEJM 1988; 319: 1022-26; Gostin, LO: Public health strategies for confronting AIDS: Legislative and regulatory policy in the United States. JAMA 1989; 261: 1621-30.

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The FDA's New Sheriff by Tabitha M. Powledge

David Kessler is that rare creature in cynical Washington: a hero. In the few months since he rode into town to head the beleaguered Food and Drug Administration, he has, for ex- ample, terrorized the food industry into using package labels that bear some relation to the contents, cracked down on misleading claims in the drug industry, and, of course, become a media star. He is also leading a revolution in drug testing and approval. The traditional clini- cal trial will never be the same, and nobody is sure whether that's good news or bad.

Among the reforms announced in November:

* Quicker approval for new drug applications, including a "fast- track" for drugs for life-threatening illnesses. Accelerated approval is supposed to reduce the time it takes to get new drugs to market, from the present ten years to an average of six. Fast-track drugs will move even more swiftly because companies can submit final data after the drug has been in use for a while. Kessler says that the agency agreed to trade ap- proval time for increased ability to get a fast-track drug off the market quickly if problems turn up.

* External review of some new drug applications by outside con- tractors. Likely contractors include statistical research companies, uni- versities, retired FDA and drug in- dustry employees, and private phys- icians-and also new, private com- panies set up for this purpose. The agency is already selecting up to a dozen new drug applications for out- side review.

Kessler insists that contract re- viewing will be confined to only a few, well-established classes of drugs-allergy and asthma drugs, analgesics, anti-inflammatory drugs, and antibiotics-that make up a third of the agency's caseload. He expects to award the first four contracts in May of 1992, the re- mainder in September, and evaluate the process after the initial phases are completed, by February 1993. Although the idea is to speed up the

process, Kessler is concerned that outside review might actually lengthen it, because the contrac- tors' reports will have to be re-re- viewed in house.

* Accepting data from foreign studies in lieu of repeating the stu- dies here. This may take some time to implement, because it requires bilateral discussions to establish re- ciprocal approval arrangements, development of common standards for clinical trials and a common for- mat for applications, and a consen- sus on manufacturing practices.

The changes include an expanded role for institutional review boards, which are now to take sole charge of decisions to proceed with the earli- est (Phase I) stage of clinical trials. Kessler also exacted a promise of more staff and money from the White House -although how that is to happen, given federal budget con- straints, is not at all clear.

A populist revolt of sorts con- tributed to these steps. Consumer groups, especially gay activists, forced the agency to agree to greater speed and lesser insistence on safety when the drug is intended for a life-threatening condition like AIDS. But capitalism is behind the changes too. The pharmaceutical industry is delighted at the prospect of a shorter time to market. Federal and state government pressure to lower prices, plus escalating re- search and development costs, have been threatening the industry's sales levels ($175 billion a year worldwide) and its apparently reces- sion-proof growth rate (10 percent annually). The Administration says the new rules will reduce industry R&D expenses by $1 billion a year.

Many in Congress, however, are not pleased. Powerful Democrats complain that outside reviewers would undermine the agency's pur- pose, and want the changes delayed until Congress can study them. The Administration's response: Not a chance.

The new rules might be viewed with less suspicion if they had come straight from Kessler. But they didn't. They came from a report by the Council on Competitiveness. Nothing covert about the Council's purpose - "to ensure that federal

Tabitha M. Powledge is a Washington, D.C. science writer and editor.

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January-February 1992

regulations do not place unneces- sary burdens on businesses"- nor about its desire to revamp drug ap- proval, which has been one of the Council's highest priorities.

The Council was already in a shootout with legislators about its behind-the-scenes part in reducing other regulations, especially on the environment. Seeking documents from the FDA relating to the Coun- cil's role in the new drug rules, a House committee had to issue a subpoena before the agency agreed to turn them over. Kessler insists that many of the Council's recom- mendations actually originated at FDA.

Like other agencies, the FDA came out of the antigovernment Eighties demoralized and downsized, with drug research staff reduced by 28 percent. Yet between 1980 and 1989, Congress passed twenty laws expanding the agency's duties, and its new product applications grew 82 percent. Kessler, like other bureaucrats, was handed the chal- lenge of doing more with less. His feisty style comes naturally, but he uses it consciously, to leverage his reduced resources. In his view, sounding as if he means business is a no-cost way of galvanizing FDA employees, filling them with a re- newed sense of mission, while at the same time sowing fear (and reaping voluntary compliance) among the regulated.

But will this public stance distract from less obvious changes that ac- tually ease regulations? Kessler's reverence for the FDA's purpose seems quite genuine. But suppose subsequent commissioners lack his commitment?

For the moment, however, Kessler is still in charge. Future targets: medical devices and conflict of inter- est. It is getting harder and harder to find expert investigators for drug studies who have no consulting ties or other interests in a drug, and conflict of interest also creates ob- jectivity problems for advisory com- mittees and IRBs. Conflict of inter- est on IRBs, he predicts, is slated for agency rulemaking. As for device review, says Kessler, that science is twenty years behind the times. What is not clear in all this is whether the sheriff is saving the interests of the townsfolk or the cattle barons.

ANNOTATIONS

Byrne, Peter, editor. Ethics and Law in Health Care and Research. New York: John Wiley, 1990.

Two chapters in this collection address issues in clinical research. Michael Baum discusses the "ir- reconcilable demands of medical ethics and clinical research." Sophie Botros's contribution, titled "Equipoise, Consent, and the Ethics of Randomised Clinical Tri- als," analyses the arguments sur- rounding equipoise and consent and of randomization and the Zelen method of prerandomization.

Johannessen, Terje. "Control- led Trials in Single Subjects: Value in Clinical Medicine." British Medical Journal 303 (20 July 1991), 173-74 [T. Johannes- sen, Department of Community Medicine & General Practice, University of Trondheim, N-7030 Trondheim, Norway].

Johannessen argues for the use of single subject (n-of-1) trials in clinical medicine, finding them at-

tractive for the study of vaguely defined conditions, useful in early phases of new drug development, and beneficial to the doctor-patient relationship. He sees n-of-1 trials as a bridge between research and clinical practice.

Levine, Carol. "AIDS and the Ethics of Human Subjects Re- search," in AIDS & Ethics, Frederic G. Reamer, editor. NY: Columbia University Press, 1991, pp. 77-104.

Levine discusses some of the complex ethical issues raised by the AIDS epidemic, which have forced reconsideration of the basic principles of nonmaleficence, autonomy, justice, and pater- nalism. Specifically, she considers confidentiality and screening, the development and accessibility of drugs, the duties of research sub- jects and of physicians, and sub- ject selection for clinical trials (with emphasis on pregnant patients with AIDS).

Continued on page 12

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