WASHINGTON, DC (November 22, 2004) – The idea of an “independent” drug safety office in the Food & Drug Administration (FDA) merits consideration, Office of New Drugs Acting Director Dr. Sandra Kweder said during the Senate Finance Committee hearing November 18 on Merck’s withdrawal of Vioxx.
“It is an idea worth looking carefully at,” Kweder said. “How it would operate, what kind of resources it would take, absolutely it’s worth looking at.”
The influential journal on prescription pharmaceuticals and biotechnology, The Pink Sheet (www.thepinksheet.com), reported that at the outset of the hearing Committee Chairman Chuck Grassley (R-Iowa) and Ranking Minority Member Max Baucus (D-Montana) declared support for an independent drug safety office, and the first panel of witnesses echoed that call.
Baucus asked Kweder to explain why creating an independent safety office would be a bad idea.
Kweder noted that a planned Institute of Medicine study of FDA’s safety review process would assess that question.
Baucus, however, pressed Kweder for an immediate opinion, saying he did not want to wait for “another study.” Kweder responded that her personal opinion is that, while “our system works very well… I don’t have any objection…to an independent Office of Drug Safety.”
“There is clearly concern by some members of the public, by members of the committee, that somehow the system is not working as well as it could without that independence. And if that’s the concern, we need to assess that,” Kweder said.
Grassley’s declaration of support for changes in structure of FDA’s regulation of drugs gives a clear focus for the Finance Committee’s investigation of the agency, beyond his desire to provide a forum for dissenters within government agencies to be heard, The Pink Sheet report said.
The Vioxx hearing primarily served as a platform for Office of Drug Safety (ODS) Associate Director for Science David Graham to offer his concerns about FDA’s approach to drug safety regulation. He described FDA as “incapable of protecting America against another Vioxx” without structural changes.
The two witnesses who testified alongside Graham – Stanford University School of Medicine Adjunct Clinical Professor Dr. Gurkirpal Singh and University of Washington Medicine & Epidemiology Professor Dr. Bruce Psaty, PhD – also endorsed the creation of an independent drug safety office.
Graham’s discussion of the drugs that he considers to have unresolved safety issues became the headline event of the hearing – and underscores the reasons why manufacturers are not eager to see independence for drug safety reviews, The Pink Sheet report continued.
Following the hearing, the FDA issued a statement by Center for Drug Evaluation & Research Acting Director Dr. Steven Galson disputing Graham’s characterization of the role of ODS, saying the ODS “is already an independent office separate from the Office of New Drugs.”
