Former FDA Chief: Agency Meant to OK Plan B

Former FDA Chief: Agency Meant to OK Plan B


Tuesday June 13, 2006 6:01 PM

AP Photo NYET803

By ANDREW BRIDGES

Associated Press Writer

WASHINGTON (AP) - The Food and Drug Administration had intended to allow
over-the-counter sales of Plan B last year but delayed the move while
determining how to limit those sales to women 17 and older - a process
that should have wrapped up by now, the agency's former chief testified.

Former FDA commissioner Lester Crawford, in a sworn statement, said he
had reserved the right to decide whether to loosen the sales restrictions
on the prescription-only emergency contraceptive pills. His account
of that unusual and perhaps unprecedented move, given in a deposition
over a lawsuit against the FDA, confirmed earlier testimony given
by two senior agency officials who said he'd shut them out of the
decision-making process.

But Crawford said his Aug. 26, 2005, announcement that the agency
was delaying its decision on Plan B wasn't a move toward denying
over-the-counter sales. Instead, it was a bid for time to work out
how to enforce restricting nonprescription sales to women 17 and older.
Girls 16 and younger would still need a prescription.

Crawford said he had expected the FDA would take six to nine months
- "tops" - to work out the enforcement issue following his August
announcement. Crawford abruptly resigned from the agency the next month;
nearly nine months later, the FDA still has not announced a Plan B
decision.