FDA Division Director Resigns, Third Official To Leave Since August

David Orloff, an FDA division director who oversees the review of drugs to treat metabolic and endocrine disorders, has announced plans to leave the agency and join Medpace, a contract research firm based in Cincinnati that runs clinical trials, the New York Times reports. Orloff, who will be the third ranking agency official to leave since this summer, spent 11 years at FDA, including five years as a division director.

Orloff was in charge of the agency's review of Bristol-Myers Squibb's diabetes drug Pargluva.

An FDA advisory committee recommended Pargluva for approval in September. In October, FDA said the drug would be approved only with additional trial data. Two days later, the Journal of the American Medical Association "published a blistering critique" of the drug's cardiovascular risks, according to the Times. After additional discussions with FDA, BMS said it would be several years before the drug could be approved.

Orloff said of the JAMA editorial, "We learned nothing new from the ... article. We were aware of all those issues." Orloff said his decision to leave the agency was not related to any concerns with the agency but rather an interest in a new opportunity. Orloff said he would continue to work at FDA for another month.

Susan Wood, FDA's top women's health official, resigned in August, and FDA Administrator Lester Crawford resigned in September (Saul, New York Times, 12/7).