Grassley Reiterates Warning About FDA Retaliation Against Safety Official

Senate Finance Committee Chair Chuck Grassley (R-Iowa) on Monday "escalated his campaign" to prevent FDA from "retaliating" against David Graham, associate director of drug safety in the FDA Office of Drug Safety, for his testimony that the agency "is not doing enough to protect the public" from potentially dangerous prescription drugs, CQ Today reports (Adams, CQ Today, 11/29).

Last Wednesday, Graham said he is facing pressure to change jobs within FDA as a retaliatory measure for his remarks before a Senate Finance Committee hearing on the Vioxx withdrawal. At the hearing, Graham said that Merck should have withdrawn Vioxx from the market years earlier and criticized agency actions related to the medication.

He also said that FDA "as currently configured, is incapable of protecting America against another Vioxx" because of ties between agency reviewers and the pharmaceutical industry.

Graham has said that FDA Acting Commissioner Lester Crawford on Nov. 9 asked him to consider a new assignment on a team reviewing the workings of the agency. Graham said that he informed Crawford that he was not interested in the new assignment. However, Graham added that he recently heard unofficially that he will be required to accept the new assignment as soon as this week.

In addition, Tom Devine, legal director for the Government Accountability Project -- which is providing legal counsel to Graham -- said that soon after Graham retained GAP attorneys, the group received anonymous phone calls from FDA phone numbers attempting to discredit Graham by accusing him of scientific misconduct. FDA officials denied Devine's allegations. However, Grassley has called on Daniel Levinson, acting inspector general for HHS, to investigate whether FDA officials misused "government resources, including property and time," by using their office phones to make anonymous phone calls questioning Graham's competence.

Donald White, a spokesperson for the HHS Office of Inspector General, said that the office would review Grassley's request for an investigation "carefully," but no decision has been made (California Healthline, 11/29).

Grassley on Monday sent a letter to Crawford, saying, "I understand that retaliatory action against dissident employees can come under many guises. Therefore, I also request that you address allegations that administrative action may be taken against Dr. Graham, including that he may be terminated or transferred against his wishes to a job other than conducting scientific research. Please advise me whether there is any truth to these allegations and, if so, explain what actions are to be taken to transfer Dr. Graham from his present position and duties at FDA."

Grassley said he expects Crawford to respond by Wednesday, adding, "I have made it clear to you that I expect that Dr. David Graham's rights as a federal employee will be fully respected by the Food and Drug Administration." Grassley also asked Crawford to notify other FDA employees that they "may come to Congress and speak freely without fear of reprisal" and without having to notify FDA's Office of Legislation or other agency officials (CQ Today, 11/29).

An FDA spokesperson confirmed that the agency had received Grassley's letter and reiterated that FDA "does not condone any form of employee retaliation." The spokesperson added that the agency cannot comment further on personnel matters for privacy reasons (Wall Street Journal, 11/30).

The House Energy and Commerce Committee has launched its own investigation into Vioxx, CQ Today reports. The committee has requested that FDA by Dec. 7 provide information on when it learned about the cardiovascular problems associated with the drug and how officials addressed the concerns (CQ Today, 11/29).

USA Today on Tuesday profiled Graham's case.

In an interview with USA Today, Graham said, "FDA made me into a whistle-blower. It wasn't my intention to be a whistle-blower." He said that FDA officials did not "appreciat[e]" his findings on the risks associated with Vioxx, adding that the agency "has made a systemic attempt to block me in the exercise of my free-speech rights."

Graham also said that the concerns he has expressed about FDA's drug-safety monitoring system have been echoed by FDA employees who monitor medical devices and biologics, but they are reluctant to come forward because they are "afraid for their jobs" (Rubin, USA Today, 11/30).