HOUSE HEARING TO DELVE INTO ALLEGED FDA DRUG REVIEW FLAWS
The House Subcommittee on Oversight and Investigations will hold a hearing to address alleged problems in the FDA's drug review policies.
The Feb. 13 hearing will address the adequacy of the agency's efforts to ensure drugs are safe, with the witnesses expected to give the FDA a failing grade, sources said. These witnesses include Sen. Chuck Grassley (R-Iowa), a prominent agency critic, and several former FDA employees who have taken the agency to task for its drug review protocols.
These former FDA officials include David Ross, former medical team leader within CDER's Division of Anti-Infective Drug Products, and John Powers, former lead medical officer for Antimicrobial Drug Development and Resistance Initiatives.
The agency has been under fire for its handling of various drugs, including sanofi-aventis' antibiotic Ketek. Grassley accused the agency of misleading an advisory committee reviewing the drug by withholding evidence of clinical improprieties.
Ross, one of the primary Ketek reviewers, testified at a Dec. 15 FDA advisory committee hearing that the agency has become a place where dissent is discouraged, transparency is shunned and drug reviewers are pressured by their superiors. The agency has denied that this is the case.