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Executive Summary

FDA Commissioner Young is scheduled to meet with representatives from the American Academy of Pediatrics on Nov. 28 to discuss the agency's progress in promulgating a final rule for oral polio virus (OPV) vaccine testing standards. The delay in reaching final standards has caught the attention of Sen. Kennedy (D-Mass.) and Rep. Waxman (D-Calif.) FDA minutes of a Nov. 6 internal agency meeting on the testing standards notes renewed Capitol Hill interest on the subject. "We have gotten inquiries from Senator Kennedy and Congressman Waxman regarding the lack of FDA activity in this area. In addition, the American Academy of Pediatrics is scheduled to meet with Dr. Young and other FDA staff on Nov. 28," the minutes state. In May 1986, FDA published a proposed rule to revise the current U.S. OPV standards to bring them in line with standards published by the World Health Organization in 1982. FDA's Vaccines and Related Biological Products Advisory Committee in January 1987 recommended that the proposed revisions be adopted ("The Pink Sheet" Feb. 2, 1987, p. 9). The final rule has been held up by FDA in response to safety concerns raised by Lederle relating to the use of World Health Organization (WHO) testing standards. Lederle's Orimune is the only OPV vaccine on the U.S. market. For about six years, Connaught Labs has had a product license application pending at FDA for an OPV vaccine that is tested under the WHO standards. Waxman, in his Aug. 9 letter to Young, noted that the American Academy of Pediatrics informed him that final action on the rule is still pending and that results of FDA-conducted studies support the proposed rule. "As Chairman of the House Subcommittee with jurisdiction over the Federal Childhood Immunization program, I am very much concerned about this delay and about its impact on the vaccine market and on vaccine prices," Waxman said. Kennedy's Sept. 22 letter also expresses concern over the rule's impact on the price of OPV vaccine. Kennedy urged Young "to quickly act to issue the final rule with respect to testing standards for oral polio vaccine." The American Academy of Pediatrics "will likely voice concern" over the status of the proposed rule "because Lederle has raised its price for the vaccine substantially and may encourage us to find an alternative approach to opening up the market to other vaccine manufacturers," FDA predicted in the meeting memo. Lederle says it has not raised the price of its vaccine in over a year. According to Lederle, the direct price to purchasers was increased in October 1988 from $ 86.71 per 10-by-1 dose to $ 101.32, which includes the tax of $ 2.90 that goes toward the Vaccine Injury Compensation Program. FDA said in the memo that it is considering several options for OPV testing standards, including: keeping the current status quo "with regard to vaccine manufacture"; publishing a final rule that "makes the polio standard more consistent with the WHO method"; modifying the standard in order "to incorporate comments received from the proposed rule and publish in a reproposal"; or publish a reproposal that allows "use of both [the current testing standards] and WHO tests." FDA's Vaccines and Related Biological Products Advisory Committee recently looked at the OPV vaccine testing standards again at the panel's Nov. 14 meeting. In both open and closed sessions, the committee heard presentations on how to define "extreme" test scores, or "outliers," that occur in monkey neurovirulence tests and how to interpret such results. The committee, in January 1987, had requested that FDA work out a way to deal with the issue of outliers. At the recent meeting, FDA Division of Virology Acting Director Paul Albrecht, MD, recommended that "everytime we have a number [of animals], maybe two . . . with such an extreme score, the tests on the vaccine should be repeated" to determine whether the results are due to the vaccine or the animal. Lederle VP-Technical Operations Frank Cano, PhD, informed the committee that the company is evaluating "improved" testing methods for OPV vaccine that may be better than either the current methods or WHO standards. Cano said that the new testing methods involve molecular biology approaches such as sequence analysis and in-process testing. The in-process testing, Cano said, may "significantly" diminish the need for neurovirulence testing in monkeys. Cano noted that Lederle is starting to make consistency lots of its inactivated polio virus vaccine (IPV) in preparation for clinical trials. The IPV vaccine will be the first product to be produced in Lederle's new Vaccine Technology Development Center in Pearl River, N.Y. The new center was dedicated in October.

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