GRASSLEY USES ALLEGED WYETH DISPUTE TO CALL FOR CHANGE IN FDA LEADERSHIP

Sen. Chuck Grassley (R-Iowa), chairman of the Finance Committee and an increasingly vocal critic of the FDA, is using an alleged effort by Wyeth to discredit an agency investigator as ammunition in his campaign to reform the agency's relationship with the pharmaceutical industry and to bolster his call for a permanent, reform-minded commissioner.

Grassley recently argued on the Senate floor that a recent dispute in which the FDA undertook a criminal investigation of one of its employees in response to an industry complaint about potential conflict of interest is further evidence that the agency remains deeply flawed.

Last year, former FDA Commissioner Lester Crawford met with Wyeth CEO Robert Essner to address the company's concerns that an agency reviewer that had criticized one of its veterinary medicines had personal and financial conflicts of interest, according to Grassley. After the meeting Crawford reassigned the staffer, Victoria Hampshire, and launched a criminal investigation against her. That investigation turned up no evidence of wrongdoing, according to Grassley.

Crawford's actions show that the agency is too close to the industry it is supposed to be regulating, Grassley said. "So, a year later, we are still uncovering the cozy relationship between the agency and the drug industry," he said. "Dr. Hampshire's sad story is further proof that the FDA needs a permanent commissioner who can restore order and respect for independence. The Food and Drug Administration cannot serve the American people and the interests of the drug industry at the same time."

Grassley argued that the first step in ensuring that the FDA is independent is to appoint a full-time commissioner, who is committed to reforming the agency. "This leader must recognize the problems of a culture that's become too cozy with the industry," he said. "Then that leader must be tough enough to make necessary changes happen." Grassley also pledged to continue to push two FDA reform bills in the Senate, the Fair Access to Clinical Trials Act and the Food and Drug Administration Safety Act of 2005.

Grassley is also targeting Wyeth for its efforts to "discredit" Hampshire and have her reassigned. In a recent letter to Essner, the senator demands that the company provide information concerning its actions, including: an explanation of how the company concluded that Hampshire had a conflict of interest; the names of all people who were involved in the company's investigation; and how many times the company has investigated agency employees.

The company intends to comply with Grassley's request and maintains that it did nothing wrong, Wyeth spokesman Douglas Petkus told FDAnews "The company believes that we have always acted responsibly and appropriately in all respects regarding this matter," he said.