ADR REPORTS CONFIDENTIALITY PROPOSED RULE
Executive Summary
ADR REPORTS CONFIDENTIALITY PROPOSED RULE would limit the burdens on firms to disclose in law suits the names of reporters and patients experiencing adverse drug events, the Pharmaceutical Manufacturers Association said in March 23 comments submitted by John Siegfried, MD, on FDA's proposed regulation. Commending the proposal, PMA noted that "once adopted, the rule will limit the amount of time companies will have to spend defending against plaintiffs' requests for release of names of patients and reporters."