Second FDA staffer resigns over deferred Plan B decision
Frank Davidoff, a member of the FDA's Nonprescription Drugs Advisory Committee (NDAC) when it voted to approve plan B for OTC sale in 2003, said the agency is ignoring science in favor of politics in delaying the drug's OTC status approval.
Davidoff is also editor emeritus of the Annals of Internal Medicine and served as a consultant to the NDAC since his term ended there earlier this year.
"There wasn't an observable scientific or procedural reason for them to first decline and then further delay the decision. I had to make the inference this was a decision that was made on the basis of political pressure and it seemed to me that was unacceptable," Davidoff told the Associated Press.
The agency announced it would defer a decision on the politically sensitive drug, pending a 60-day public comment period. That decision came despite an earlier promise to Congress from FDA Commissioner Lester Crawford to make a final decision on Plan B by Sept. 1.
Davidoff's resignation came in September and followed the resignation of Susan Wood, the top women's health official at the FDA in August and preceded the resignation of Commissioner Lester Crawford two weeks ago.
Senators Hillary Clinton (D-N.Y.) and Patty Murray (D-Wash.) placed a hold on Crawford's nomination to commissioner in June, demanding a yes or no decision on the drug, but relented in July when he issued a Sept. 1 deadline.