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FDA FOOD/DRUG SEPARATION URGED BY CLINICAL PHARMACOLOGY GROUP IN COMMENTS TO EDWARDS BLUE RIBBON PANEL; NONCOMMERCIAL IND PROCEDURE CHANGES ADVISED

Executive Summary

Redelegation of FDA's regulatory authority to separate out foods and focus on drugs, cosmetics and other medical products was suggested by the American Society for Clinical Pharmacology and Therapeutics in Aug. 2 comments to the Edwards Committee. "FDA's responsibility for foods ought to be deleted and given to [the Department of Agriculture]," the society said. "Certainly the responsibility for 'drugs and cosmetics' seems to be an entirely sufficient obligation." The comments of the clinical pharmacology society were signed by ASCPT Government Affairs Chairman Gilbert McMahon, MD. During the early 1980's, McMahon chaired a congressionally-chartered Commission on the Federal Drug Approval Process. The concept of making structural changes to FDA to narrow its wide range of regulated products is one of the ideas that is getting renewed attention as a result of HHS Secretary Sullivan's establishment of the Edwards Committee. In addition to the clinical pharmacology group, Genentech Chairman Robert Swanson specifically suggested the breakup of the agency in earlier comments to the committee ("The Pink Sheet," Aug. 20, T&G-3). While the arguments for breaking up the agency may be appealing as an exercise in logic and organization planning, practically such a solution would be difficult. The required dismantling and revision of the FD&C Act would open the door for extensive changes in the laws. That kind of legislative review of FDA's empowering act could create an open season for the review of all of FDA's regulatory authority. A breakup of FDA's functions would also raise policy issues related to the increasingly "medicinal" nature of some food claims and to FDA's traditional role as a non-advocacy regulator of food production. Suggestions to turn the regulation of foods back to the Agriculture Department have traditionally been questioned because Agriculture is viewed as an advocate for the food production industries and FDA has been viewed as a more impartial regulator. In its Aug. 2 comments, the clinical pharmacology society also addressed the issue of FDA autonomy within HHS. FDA's "present status with HHS and requiring [Office of Management and Budget] oversight, tends to remove it from developing into a purely scientific body," the comments said. FDA should be "depoliticized...buffered by a prestigious group of medical-scientific advisors. Some oversight is probably necessary, but could it not be accomplished via a scientific body rather than politically?" ASCPT urged "less bureaucratic red tape and Congressional interference with management's function" if FDA hopes to "become competitive with industry for quality scientists and managers." The society's comments were echoed in a July 30 submission by Merck Scientific Development Exec Director William Abrams, MD, who has just completed a stint with FDA as organizer and head of an office of professional development at the Center for Drug Evaluation and Research. Abrams suggested that delays in IND/NDA approvals may be attributed to the fact that the relatively small numbers in senior management at CDER are "extended by administrative duties in a bureaucratic environment" and distracted by "'fire fighting' and calls to appear before or prepare the commissioner for Congress, HHS, etc." Abrams also stated that "since the Centers for Drugs, Biologics and Medical Devices operate on scientific based issues more akin to the NIH than to other governmental agencies, perhaps a select board of directors would buffer them from special interests within and outside the government, allowing senior managers to manage the drug process." The clinical pharmacology group suggested consideration of a 1982 McMahon Commission recommendation that FDA separate review procedures for commercial and noncommercial INDs. The suggestion was also contained in the recent Lasagna committee report to the White House ("The Pink Sheet" Aug. 20, p. 3). Advising that the IND process be "simplified," the society noted: "As recommended by the McMahon Commission...FDA should establish separate procedures for pharmaceutical INDs and research INDs." FDA Treatment IND regs published on May 22, 1987 ("The Pink Sheet" May 25, 1987, p. 3) "are a step in the right direction" with regard to separating INDs, "but at the present time many U.S. drug discoveries are being studied initially outside of this country because of more reasonable government requirements abroad," ASCPT maintained. The early phase of clinical pharmacology "ought not to require an IND," the comments said. ASCPT added that "patient safety and welfare can be protected by institutional review boards as well as written consent." During 1988, the society noted, "there were some 7,000 'research' INDs and 2,500 'commercial' INDs. Nevertheless, FDA had to monitor all of them." According to recently released data from FDA, at the end of 1989, there were over 9,500 active INDs on file at FDA; 2,752 were commercial INDs (see related story p. 3). With regard to the NDA system, ASCPT suggested that "the principle of 'first in, first reviewed', should apply with the caveat that therapeutically important new drugs receive priority review." The society added that "NDAs could be greatly simplified so that only certified summaries of preclinical and clinical studies be required." In separate comments, U.S. Pharmacopeial Convention Executive Director Jerome Halperin discussed the independence of FDA in terms of the agency's access to Public Health Service resources. Basing his comments on his "personal views" as a former FDA employee and not as a representative of USP, Halperin pointed out: "By becoming independent, FDA would have the advantage of an independent agency, but by becoming independent, FDA may lose some of the advantages of being within the Department of Health and Human Services." Halperin's written comments were similar to a presentation made by former FDA Acting Commissioner Mark Novitch to the Edwards Committee earlier this summer ("The Pink Sheet" July 23, p. 5). Halperin ponted out, for example, that "access to Public Health Service officers is an important benefit to attracting new personnel." He noted that "the two most recent commissioners (Hayes and Young) have been PHS officers." He also noted center and bureau directors who were former PHS officers, such as John Villforth (Center for Devices and Radiological Health), Gerald Meyer (Center for Biologics Evaluation and Research) and Richard Crout (Drugs). A "host" of FDA employees at various levels "from deputy bureau director to entry level people have been and are PHS officers," Halperin added. "Whether the potential opportunity cost of the inability to employ PHS officers is high enough to offset the advantage of bureaucratic independence is a matter for consideration." The issue may be less important, he continued, "if adjustments are made to the compensation system to provide high level staff with equal compensation that they receive under the corps system." Halperin also suggested that Congress "revisit" the FD&C Act to consider redefining products to help FDA keep up with new technologies such as medical foods or "cosmeceuticals." Such " 'interface' products embodying the attributes of drugs and foods...drugs and cosmetics...and drugs and devices...have a tortured path through the agency and frequently get mired down in intercenter jurisdictional disputes," Halperin pointed out. "Definitions of the 1930s are not serving technologies of the 1990s well."
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