FDA Ordered to Produce Documents Pertaining to Safety of PPA

SEATTLE - A federal judge ordered the FDA to produce documents regarding the agency's regulation of phenylpropanolamine (PPA) in order for Wyeth to defend plaintiffs' allegations that the FDA and manufacturers of PPA-containing products knew of the dangers of the drug prior to its removal from the market in 2000. In re: Phenylpropanolamine (PPA) Products Liability Litigation, MDL 1407 (W.D. Wash.).

U.S. District Judge Barbara Rothstein's Nov. 12 order stated that although the documents fall within the ambit of the deliberate process privilege, denying Wyeth access to the documents would prevent the company from defending claims that the FDA concluded …