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Executive Summary

FDA COMMISSIONER KESSLER TO TESTIFY AT APPROVAL PROCESS HEARING scheduled for March 19 before the House Government Operations/Intergovernmental Relations Subcommittee chaired by Rep. Weiss ("The Pink Sheet" March 9, In Brief). The hearing will examine FDA's plans to implement NDA/IND review recommendations made by Vice President Quayle's Council on Competitiveness last autumn ("The Pink Sheet" Nov. 18, 1991, p. 3). The subcommittee has not yet identified other health experts scheduled to testify at the hearing; however, Health Research Group Director Sidney Wolfe, MD, is a likely candidate to appear among non-agency witnesses. The hearing will focus on several aspects of the council's recommendations, specifically one calling for FDA to rely on external NDA reviews. "FDA has begun implementing a plan to farm out to nongovernmental entities the review of certain drug applications," the subcommittee noted in a March 12 release. The agency has drafted contracts for eight to 12 outside reviews and reportedly has begun contacting potential reviewers. At the announcement of the council recommendations, Kessler estimated the cost of the external reviews at "$100,000-$200,000 per NDA" and said HHS Secretary Sullivan was committed to obtaining $1 mil. to $2 mil. in funding for the project. Reportedly, no funds are budgeted for the contracts currently. Weiss (D-N.Y.) is particularly concerned that, although FDA retains final approval authority, it "would ordinarily base its decision solely upon the report" from the outside reviewer. The council said "FDA will not need to conduct its own analyses of the data but can use analyses of data that have been certified by the external organization in making its determination that the treatment should be approved." FDA said it would select NDAs for outside review from four drug categories, including nonsteroidal anti-inflammatory drugs. During the 1980s, Weiss held hearings on the approval of at least three FDA-reviewed NSAIDs that later proved to pose toxicity problems: Oraflex, Zomax and Suprol. In the press release announcing the hearing, Weiss contended that "experts in and out of government are concerned that the public health will suffer if FDA fully implements several of the Quayle council's reforms." The subcommittee's "preliminary investigation suggests that FDA has serious misgivings about these proposals but has been overruled by the White House. We want to know why," Weiss said. The New York Democrat also is questioning FDA's plans for applying accelerated approval procedures for drugs for life- threatening illnesses to therapies for less serious diseases. FDA's proposed regulation to approve drugs for "illnesses such as AIDS and cancer with less than the normal amount" of safety and efficacy data "is not controversial," the subcommittee said. "However, over FDA objections," it contended, "the White House is forcing the agency to significantly expand the scope of the draft regulation to include any condition, regardless of severity, if there is no satisfactory alternative therapy." Weiss is especially concerned that the White House directives for FDA were developed at the behest of regulated industry. The subcommittee said the proposals "were devised by the Quayle council following private meetings with industry groups." The council "had two private meetings in 1991 with industry groups representing drug and biotechnology companies," the subcommittee noted. "At those meetings, the trade associations recommended changes they would like to see made in FDA's approval process. The Quayle council plan released last November bears a strong resemblance to the specific suggestions made by the industry groups," the panel said. "All" the proposals "have since been endorsed by the Pharmaceutical Manufacturers Association." The hearing also will examine the recommendation that IND applications be reviewed by independent IRBs instead of FDA. In the past, Institutional Review Boards have expressed no interest in reviewing INDs. However, Weiss nonetheless is concerned because FDA has drafted a proposed regulation for IRB reviews of INDs. "The typical IRB has no expertise in toxicology, pharmacology or any of the other specialties that FDA scientists are trained in to determine whether a proposed human experiment is safe," the subcommittee maintained. Rep. Waxman (D-Calif.) is scheduling an April 1 oversight hearing that also may focus on the Competitiveness Council's drug approval recommendations. Other possible subjects for the House Energy & Commerce/Health Subcommittee hearing include the timeliness of agency rulemaking, particularly the OTC Drug Review. During the hearing, Waxman is expected to release a report by the General Accounting Office on the time it takes FDA to publish its regulations.

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