"Top F.D.A. Staff Members Oppose Looser Drug Approval System"

Important note: Information in this article was accurate in 1991. The state of the art may have changed since the publication date.

"Top F.D.A. Staff Members Oppose Looser Drug Approval System"

New York Times (12/20/91), P. A29
Hilts, Philip J.

Abstract: The Food and Drug Administration's new policy to hasten drug approval by allowing private groups to review the testing of new drugs has faced severe opposition by a majority of the leading F.D.A. staff members. The proposal is one of many that the White House has recommended and that the Commissioner of the F.D.A. has agreed to try. However, yesterday the Public Citizen Health Research Group released the results of a survey that suggests that more than 80 percent of the top medical authorities at the F.D.A. opposed these parts of the proposal. The survey was conducted among 121 medical officers. Critics say that diverting authority to private groups may make them susceptible to influence by drug companies and would possibly lower the agency's high review standards. Among the 11 proposals, three of them would permit private contractors, rather than the F.D.A.'s own staff, to review experiments testing new treatments. Several written comments on the questionnaire stated that local review boards are not qualified enough to conduct the experiments correctly.

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