Showing posts with label FDA Commissioner Choice Obama Grassley Waxman Outsider DTC ENHANCE Schering January 29 2009. Show all posts
Showing posts with label FDA Commissioner Choice Obama Grassley Waxman Outsider DTC ENHANCE Schering January 29 2009. Show all posts

Thursday, January 29, 2009

Chairman Henry Waxman's Views on the Next FDA Chief. . . .


MedPage Today reports thus:

. . . .Waxman and several other lawmakers, including Sen. Charles Grassley (R-Iowa), the ranking minority member of the Senate Finance Committee, spoke at today's conference.

Grassley targeted the FDA, accusing the agency of being more concerned with "looking good" than anything else.

Pointing to the need for significant change at the FDA, Grassley said an outsider should take the helm to "shake things up" and focus on postmarketing surveillance.

One such outsider is Steven Nissen, M.D., director of cardiovascular research at the Cleveland Clinic. Dr. Nissen, who is known to be on the short-list for the FDA post, has been a frequent visitor at Grassley's Senate office.

Grassley has been turning up the heat on the FDA. He has spearheaded several investigations of the pharmaceutical industry, most notably a probe into Merck and Schering-Plough for direct-to-consumer advertising of ezetimibe/simvastatin (Vytorin) and the companies' handling of results of the ENHANCE trial.

Asked about Grassley's outsider comment, Waxman said he didn't know who the Senator had in mind, but said that Josh Sharfstein, M.D. "would be excellent" as FDA commissioner.

Dr. Sharfstein, who is Baltimore's health commissioner, is considered the front-runner to head the FDA. Before taking the job in Baltimore, he served on Waxman's congressional staff.

Waxman said that Dr. Nissen would also be a good choice, but said, "it's not my choice. It's up to the president. . . .