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PPA

This article was originally published in The Tan Sheet

Executive Summary

Statement disclaiming product liability relevance of FDA's decision to remove PPA from OTC cough/cold products should be included in final withdrawal determination, Novartis, Schering-Plough assert in separate comments to agency. Both firms request FDA issue a disclaimer resembling one used in a March 1999 final action, which states: "The agency wishes to emphasize that the inclusion of a drug product on the list does not mean that the drug product was marketed negligently, was defective or was marketed in breach of any warranty." FDA hearing on proposed PPA withdrawal is unnecessary as all products containing ingredient were pulled from shelves after de facto recall last November, firms say

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PPA

Industry-proposed disclaimer on product liability relevance of NDA withdrawals is "incorrect on the facts" and "outside the scope of FDA's jurisdiction and authority," Philadelphia plaintiff law firm Levin, Fishbein, Sedran & Berman assert in Sept. 28 letter. "FDA has not conducted any factual investigation of the marketing practices of the various drug companies which manufactured and distributed PPA products and it has no basis for determining whether such companies were negligent or breached any warranties made to consumers," firm says. Several companies requested FDA state that any order withdrawing PPA approvals is not intended to be used as evidence in lawsuits (1"The Tan Sheet" Sept. 24, In Brief)

PPA

Industry-proposed disclaimer on product liability relevance of NDA withdrawals is "incorrect on the facts" and "outside the scope of FDA's jurisdiction and authority," Philadelphia plaintiff law firm Levin, Fishbein, Sedran & Berman assert in Sept. 28 letter. "FDA has not conducted any factual investigation of the marketing practices of the various drug companies which manufactured and distributed PPA products and it has no basis for determining whether such companies were negligent or breached any warranties made to consumers," firm says. Several companies requested FDA state that any order withdrawing PPA approvals is not intended to be used as evidence in lawsuits (1"The Tan Sheet" Sept. 24, In Brief)

PPA

Industry-proposed disclaimer on product liability relevance of NDA withdrawals is "incorrect on the facts" and "outside the scope of FDA's jurisdiction and authority," Philadelphia plaintiff law firm Levin, Fishbein, Sedran & Berman assert in Sept. 28 letter. "FDA has not conducted any factual investigation of the marketing practices of the various drug companies which manufactured and distributed PPA products and it has no basis for determining whether such companies were negligent or breached any warranties made to consumers," firm says. Several companies requested FDA state that any order withdrawing PPA approvals is not intended to be used as evidence in lawsuits (1"The Tan Sheet" Sept. 24, In Brief)

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