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Executive Summary

REP. GORE's Rx-TO-OTC SWITCH BILL: PROVISION FOR GRANDFATHER DRUGS ought to be added to the proposed legislation, the Health Research Group (HRG) suggested in a recent letter to the Tennessee Democrat. Noting that "the bill covers drugs which have obtained approved new drug applications," HRG pointed out there are a number of drugs "first marketed prior to 1938 which therefore qualify for the statutory grandfather provision." It is possible, HRG said, that "the FDA will allow some of these drugs to be sold OTC in the future, and competitors could be required under the FD&C Act to obtain approval by filing a new drug application. Therefore, you might wish to consider including a provision in your bill which would permit competitors of these grandfather drugs to obtain the waiver approval, which sellers of approved drugs may obtain." HRG was commenting on Gore's draft legislation, circulated last month, which would establish an ANDA type review system at FDA for Rx products switched to OTC marketing status by the agency ("The Pink Sheet" July 23, p. 3). Under the proposal, a company could request FDA to grant a waiver from full NDA requirements for switched products that have previously been marketed on an Rx-only basis for at least five years. One intent of the bill, Gore said in a letter to interested parties who received a copy of the draft, is to "preserve the role of smaller companies in the OTC marketplace by facilitating competition." HRG, endorsed that objective, noting that "in general, we favor the draft bill because it would promote competition among OTC products." The consumer group suggested, however, that a requirement for adverse reaction reporting for waiver drugs should be strengthened in the bill. Maintaining that Gore's draft approach would "merely authorize" the HHS secty. to "adopt regulations providing for adverse reaction reporting," HRG said that "this is comparable to the language currently applicable to new drugs in" the FD&C Act. "In our view," HRG declared, "adverse reaction reports are sufficiently important to justify explicit language requiring companies to submit these reports, rather than simply authorizing the secty. to do so. The statutory language could be taken directly from FDA's current regulations."

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