On November 18, 2004, FDA Associate Director David J. Graham testified before the U.S. Senate Committee on Finance after Merck withdrew the anti-inflammatory drug Vioxx the previous month because of serious safety concerns. Graham said FDA policies were inadequate to protect the public from drugs with unacceptable risks, declaring that the agency was “incapable of protecting America against another Vioxx” and that the public was “virtually defenseless.” His testimony placed the regulator’s post-approval drug-surveillance system, rather than only Merck’s withdrawal decision, under scrutiny.
The FDA publicly criticized Graham after his testimony. He then sought advice from the Government Accountability Project, a nonprofit whistleblower-protection organization, to publish his Vioxx findings over objections from his superiors. In a 2005 interview, Graham alleged that FDA was institutionally biased toward pharmaceutical companies and treated industry as its client, prioritizing approvals over safety or medical necessity. His broader record included work associated with removing or restricting drugs such as Rezulin, Fen-Phen, Redux, Trovan, Lotronex, Baycol, Seldane, and Propulsid. In 2010, Graham and FDA colleague Kate Gelperin also urged withdrawal of Avandia, citing possible increased mortality, though their findings differed from other published studies.
