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FDA APPEARS SET ON RETENTION OF SALE PROVISION FOR IND DRUGS, AGENCY INDICATES AT IND HEARING; SALE PROPOSAL HAS SUPPORT OF EX-FDA OFFICIALS

Executive Summary

FDA appears inclined to stick by its plan to allow the sale of drugs under the proposed treatment IND regulation. In testimony before the Subcommittee on Human Resources and Intergovernmental Relations on April 29, FDA Commissioner Young maintained that the sale provision of the proposed rule would allow availability of promising drug therapies that might not otherwise be available. Young acknowledged that comments on the proposal questioned whether "a broadened treatment IND program would impose excessive costs on desperately ill patients." FDA recognizes that "this is a sensitive issue," Young said, "however . . . these drugs may not be made widely available if the sponsor is unable to charge for the drug." Subcommittee Chairman Weiss questioned the agency topsiders about Office of Drug Research and Review Director Robert Temple's objections to the sale provision of the proposed rule. "Are you aware that Dr. Temple believes the sale portion of the proposed regulation . . . violates the FD&C Act?" Weiss asked. The Subcommittee Chairman quoted a letter written by Temple to FDA Center for Drugs and Biologics Acting Director Paul Parkman, MD, stating that the proposed reg "obliterates a section of law allowing marketing (sale, anyway) of a new drug that has met no standard at all, except for obtaining an IND." In response, Deputy Commissioner Norris said: "Dr. Temple told me himself in a conversation last week that he was not troubled by the sale provision per se." FDA General Counsel Thomas Scarlett also said that he did not believe Temple viewed the sale proposal as violating the FD&C Act. Weiss questioned Scarlett about the legality of the sale proposal. "My understanding is that [the FD&C Act] says that unless the use of the new drug is intended solely for investigational purposes, it is prohibited from being introduced into interstate commerce if it is not the subject of an approved new drug application," Weiss said. "And my question is, doesn't the sale of that new drug run counter to that prohibition?" Scarlett maintained that the sale proposal does not constitute commercialization. He explained that there is a similar sale provision for investigational medical devices "and that is not regarded as commercialization." A group of former FDA officials also testified that they do not object to the sale of IND drugs per se, but they added that some evidence of efficacy must be a precondition for allowing such sales. In written testimony submitted jointly by former FDA Commissioners Jere Goyan, PharmD, Arthur Hull Hayes, MD, Charles Edwards, MD, Donald Kennedy, PhD, Alexander Schmidt, MD, and former general counsels Nancy Buc, Richard Cooper, Peter Barton Hutt, and Richard Merrill, the ex-FDAers said: "We have no general obligation to the sale of drugs administered under an IND." The former officals pointed out, however, that "if there were no requirement for some rational basis for believing an investigational drug may be effective, the permission to sell it . . . could provide an unintended opportunity for the marketing of governmentally legitimized quack drugs." The proposed rule allows FDA to prohibit pricing of investigational drugs that is "manifestly unfair." Explaining FDA's role in the pricing of IND drugs, Commissioner Young stated: "Clearly FDA is not designed now, nor in the future, for establishing the prices of drugs. I want to clearly emphasize that it is not FDA's goal to be a price regulatory agency for pharmaceuticals." Scarlett told the subcommitte that FDA does not "have any specific criteria [for determining what constitutes manifestly unfair pricing] at the current time." However, he said that he did not believe pricing that earns sponsors a profit on investigational drugs would automatically constitute manifestly unfair pricing.
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