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ORAL POLIOVIRUS VACCINE U.S. MARKET ENTRY BY FOREIGN FIRMS

Executive Summary

ORAL POLIOVIRUS VACCINE U.S. MARKET ENTRY BY FOREIGN FIRMS would be facilitated by FDA's proposed revision of OPV manufacturing standards, Connaught noted in recent comments on the proposed rule. Endorsing the proposed rule, Connaught said: "The formalization of the proposed additional standards would allow international manufacturers of OPV to obtain FDA license approval since the proposed additional standards incorporate many of the well accepted criteria and procedures adopted by Canada, England, and the World Health Organization (WHO)." FDA noted in the proposed rule that the "proposed amendments would facilitate the licensure for U.S. distribution of oral poliovirus vaccine currently meeting international standards of safety and efficacy." FDA stated in the proposal that it was revising the regs, in place since the 1960s, for four reasons: (1) "to update the regulations consistent with current scientific knowledge and the standards of WHO"; (2) "to facilitate the licensure of safe and effective vaccines"; (3) "to reduce the regulatory burdens of the regulations"; and (4) "to improve the clarity of the regulations." The proposal was published in the Federal Register on May 5. Lederle has been the sole U.S. supplier of the trivalent form of OPV, the only form currently used in the U.S., since 1979. In its comments to FDA, Connaught, which manufactures OPV for markets in Canada, Europe, South America, and several developing countries, estimated the U.S. OPV market at about $150 mil. Lederle maintains that $150 mil. is a "gross exaggeration" of the U.S. market size. FDA announced July 16 that the comment period on the OPV proposal, which had been set to expire July 7, would be extended 30 days, to August 6, based on a request from Lederle to extend the comment period 90 days. FDA noted "that an additional 30 days is appropriate to assure that Lederle and other interested persons may thoroughly review the proposed rule." Connaught objected to Lederle's request for a comment extension. Connaught maintained that "to extend the comment period for any length of time will clearly delay the approval of any OPV license application which may be pending at the agency at this time. Such a delay in approval will allow Lederle to bid unopposed for this year's OPV contract with the Centers for Disease Control." Connaught also stated that "it is in the public interest to quickly finalize the OPV additional standards." Should "the sole source manufacturer of OPV in the U.S. encounter a manufacturing problem or other difficulty temporarily or permanently interrupting the sole supply of OPV in this country, a serious public health problem could be presented since there is no readily available alternate source of OPV for America's children," Connaught said. The firm added that "if such a horrible occurrence did take place during the course of this rulemaking, delayed on account of this request for an extension of the comment period, allegations could be made that the agency placed one company's economic concerns over the health and well-being of America's children." Noting Connaught's concerns, FDA said in its comment extension that "the agency does not believe that an extension for this period of time will significantly or unreasonably delay the issuance of a final rule."
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