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ORAL POLIO VACCINE RULE CREATES "DIFFICULT" PRODUCT LIABILITY SITUATION

Executive Summary

ORAL POLIO VACCINE RULE CREATES "DIFFICULT" PRODUCT LIABILITY SITUATION for manufacturers, Rep. Dingell (D-Mich.) states in a recent letter to FDA Commissioner Kessler. Responding to the agency's OPV testing standards rule published in the May 8 Federal Register, Dingell (D-Mich.) maintained that FDA, by allowing two acceptable testing standards, "places vaccine manufacturers in a difficult position, where product liability lawyers will be able to second guess the decision to use one test or the other." FDA's final rule on neurovirulence testing of oral polio vaccines, published almost exactly five years after the proposed rule, allows manufacturers to use either current U.S. testing standards or the World Health Organization's neurovirulence testing standards ("The Pink Sheet" May 20, T&G-6). In explaining its decision, FDA said that allowing the new standard would improve the U.S. oral polio vaccine supply by permitting another manufacturer to enter the polio vaccine market. The rule also refers to the WHO standard as the "preferred" standard, a distinction Dingell said will create a problem "particularly acute for a U.S. manufacturer who chooses to continue to use the U.S. standard." Dingell added that he is "strongly opposed to any situation where regulations promulgated by a U.S. regulatory agency put a U.S. company which uses U.S. standards at risk." Dingell has been interested in the amended oral polio vaccine testing standards since they were first proposed in 1986, when he wrote to then-Commissioner Young to request that the proposed amendments to OPV testing procedures be reviewed by an advisory committee before the agency took any final action. The Vaccines and Related Biological Products Advisory Committee in January 1987 recommended the adoption of the WHO standards. FDA's final rule was published just three weeks after a Maryland federal court ruled that FDA has been in violation of its own regulations during the nearly 30 years it has overseen the approval of oral polio vaccines. FDA reacted quickly to correct what District Court Judge J. Frederick Motz called the "critical error" of not amending the poorly written regulations in 1962; the agency issued its final ruling on May 8 and waived the usual 30 day delayed effective date of the new regulation. However, on May 22 FDA published another Federal Register notice staying the effective date of most of the new rule until June 21. FDA explained that immediate action was "essential only with respect to" the sections that extended a grandfather clause of legality to existing batches of vaccine produced before the final rule and clarified the phrase "original strain." Nonetheless, in a May 28 meeting with Lederle, Commissioner Kessler declined to stay or suspend the final rule. Lederle filed a June 6 Petition for Stay of Action, and on June 7 filed Objections and Requests for Public Hearing. According to Lederle's counsel, under the FD&C Act, the filing of these documents should act automatically to stay the provisions of the final rule pending a public hearing or a notice rejecting the petition. Lederle charges in its filings that WHO testing standards are unproven and that evidence suggests "the WHO test has not been validated against the existing neurovirulence test and has not been shown to correlate with clinical safety in the United States." Lederle also alleges that U.S. vaccines contain up to six times more live-virus particles than WHO vaccines, and as such, the WHO testing standards have little history of reliability with U.S. vaccines. The company further cited the alleged unique ability of the U.S. test to identify a virus having an "incorrect sequence" of the polio genome that would mark it as inappropriate for use in vaccine. In addition, Lederle also pointed to the product liability uncertainties created by the existence of two standards for neurovirulence testing. The issue is also raised in June 3 comments on the rule submitted by torts specialist Victor Schwartz, from the D.C. law firm of Crowell & Moring, who called the rule allowing two different standards a "tort nightmare." Schwartz predicted that the new rule would encourage liability lawyers to eschew the Vaccine Compensation Program in favor of direct lawsuits against manufacturers. He estimated that such actions would cost $ 50 mil. annually, adding that "if WHO-tested vaccines prove to be less safe, those numbers could skyrocket." Both Lederle and Ontario-based Connaught, which manufacturers OPV based on WHO standards, have expressed their willingness in the past to support a single compromise test. Lederle supports an "appropriate alternative which will ensure that our safety margin remains undiminished," while Connaught, in a August 11, 1987 letter to then-FDA Commissioner Frank Young, said it would be willing to add an intrathalamic test to its standard WHO criteria, if so required. The American Academy of Pediatrics, which favored the adoption of WHO standards, said on June 14 that "at this time, our policy is to support the regulations as originally issued by FDA." The academy said it "is looking to do whatever we can to get more competition in the vaccine market." The academy noted that it is reviewing Lederle's submissions to FDA and hopes to submit an advisory opinion to Commissioner Kessler within the next week.
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