FDA punts on Plan B
FDA Commissioner Lester Crawford said the agency needed to weigh transparently the "difficult and novel policy and regulatory questions" inherent in placing a product on the market in both prescription and OTC forms, for the same indication, as defined by age. Enforcement was also a concern, he said.
"What we are saying today is that the Agency is unable at this time to reach a decision on the approvability of the application because of these unresolved regulatory and policy issues that relate to the application we were asked to evaluate," said Crawford.
Crawford said the agency would hold an expedited 60-day public comment period, rather than the standard 90 or 120 days, but did not say when it might be held. Barr Laboratories said the agency would not commit to any timetable in discussions. Barr quoted an agency letter as saying that the Center for Drug Evaluation and Research "has concluded that the available scientific data are sufficient to support the safe use of Plan B as an OTC product...for women who are 17 years of age and older."
Senators Hillary Clinton (D-N.Y.) and Patty Murray (D-Wash.) blasted the agency, which they said "not only broke their promise to Congress, they broke their promise to the American people." The move, said the senators, "serves only to increase questions about the FDA's status as an independent agency."
Senators Clinton and Murray had placed a hold on the nomination of Lester Crawford to FDA commissioner in June, demanding a yes or no decision on the drug, but relented in July when promised a decision by September 1.
A supplemental new drug application was first submitted for all ages in April 2003. The FDA rejected it, citing concerns that the drug had not been tested sufficiently in women under the age of 16, and in July 2004, Barr resubmitted Plan B for OTC sales to women 16 and older.