Public Citizen Twists Study to Smear Bureaucrats
A new study in the New England Journal of Medicine by researchers at Harvard suggests that the drug approval timeframes included in the Prescription Drug User Fee Act (PDUFA) result in more safety problems once products are in clinical use.
Unfortunately, an official with Public Citizen twisted the study’s statistical findings to imply that FDA officials were corrupt. Specifically, a senior PC official is quoted as saying "So you have reviewers and scientists at the FDA who are dependent for their salaries in part upon the very industry who they're supposed to be regulating. That is a conflict of interest and, we think, is going to lead to less safe drugs getting on the market." PC’s claim regarding the supposed impact of the PDUFA funding mechanism was not even part of the Harvard study.
Meanwhile, the FDA "did its own review and found no statistical difference in problems with drugs approved before, near or after deadline." The "head of FDA's Center for Drug Evaluation and Research said FDA’s not obligated to meet" the PDUFA "deadlines Congress imposed and that the agency’s reviewers can take more time if they're concerned about safety." Moreover, the "agency also claims Harvard’s numbers are off." The agency’s Economics Staff Director explained that "Because we have found at least two fundamental problems with their data, we don't think their conclusions hold up."
Investigating the safety effects, if any, of PDUFA is a legitimate topic of inquiry. Baselessly impugning the integrity of FDA’s scientists and other officials, however, is simple sleaze that’s best left in the gutter where it belongs.
See NEJM Abstract
See NBC News story
