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FDA ACTIONS AGAINST DRUG MANUFACTURERS SHOULD BE AVAILABLE TO PROVIDERS UNDER FD&C ACT, APhA TELLS DINGELL; MANDATORY TWO YEAR POST-MARKETING STUDIES URGED

Executive Summary

FDA should make enforcement actions against drug companies available to "interested health care professionals," American Pharmaceutical Association Exec VP John Gans urged House Commerce/Oversight Subcommittee Chairman Dingell (D-Mich.) in a March 1 letter. Gans suggested that FDA be required to "develop and make available to health care professionals a brief summary of the most recent inspection reports, recalls, and other action taken by FDA with respect to all pharmaceutical manufacturers." The purpose of Gans' letter to Dingell was to make substantive recommendations to be included in Dingell's legislative revisit to the FD&C Act to deal with problems that have arisen in the generics scandal (see related story, p. 3) The APhA exec also suggested that FDA publish a rating system that would allow pharmacists and physicians to make determinations on products based on the dependability and quality of the manufacturer. The letter to Dingell suggests that FDA "develop a rating system for companies which would give health care professionals information on the relative dependability and quality of the drug manufacturers." Gans added that "a listing of the numbers and nature of the discrepancies noted on that year's inspection reports (483's) could be helpful." Echoing APhA President David Cobb's March 1 written testimony to the Consumer Interests Subcommittee of the House Select Committee on Aging, Gans emphasized the need for more complete information on drug labeling in order to help pharmacists and physicians choose quality drug products ("The Pink Sheet" March 5, p. 9). Gans also elaborated on Cobb's proposal for mandatory FDA review of all pre-1938 drugs. Without such approval, Gans said it is "difficult for physicians and pharmacists to determine the relative bioavailability of generic copies of pre-1938 drug products." * In an effort to shorten drug approval times, Gans suggested legislating a mandatory two year post-marketing surveillance study for all new drugs. "FDA could use the information from this type of study" to help determine "both previously undiscovered side effects and new indications for marketed drug products." Gans predicted that NDA holders would agree to such a study as a prerequisite for approval. A legislatively mandated post-marketing surveillance program could also facilitate the Rx-to-OTC switch process, Gans said. The plan "could be used to establish a transition class" of Rx-to-OTC candidates. While this new class of drugs would not require a prescription, the drug would be available only through the pharmacist. This "additional safety requirement...would ensure that the public had easy access to advice about the medication and its proper use," Gans said. In addition, pharmacists would be used as "investigators" in the post-marketing study to aid FDA in its final decision on the switch. APhA also recommended that the Generic Drug Advisory Panel proposed by HHS Secretary Sullivan and former FDA Commissioner Young last year be established through legislation to ensure its permanence "after the current crisis has been resolved." FDA should also be given more authority to punish companies which gain approvals through fraud or misconduct. In turn, the companies should have a clear avenue of appeal. APhA requested that Dingell consider expanding FDA's regulatory activities involving independent contract research labs. "While almost all of the human testing done in support of generic drug approval is performed by" these research firms, Gans noted, "FDA does not have explicit authority to inspect those companies. It should be given such authority." Discussing FDA inspections of industry facilities, Gans said the legislation should "include additional funding and enlarge the FDA investigational staff to ensure that every company manufacturing drug products is inspected on a random basis at least once a year."

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