FDA once again delays Plan B's OTC bid

The agency's move to open a rule-making process on the emergency contraceptive pill's availability will hold up approval indefinitely.

By Kevin B. O'Reilly, AMNews staff. Sept. 19, 2005.

Overruling its own drug-review staff's recommendation, the Food and Drug Administration in late August again delayed a decision on whether to approve over-the-counter status for the emergency contraceptive pill known as Plan B, or the morning-after pill.

FDA Acting Commissioner Lester Crawford, DVM, PhD, said a drug manufacturer's application to make the morning-after pill prescription-only for girls younger than 16 but OTC for those 16 or older was unprecedented. He said the dual-status application posed novel regulatory and policy questions that had to be resolved through an open rule-making process, including figuring out how the age restriction would be enforced.

The rule-making process began with an expedited 60-day comment period set to conclude Nov. 1. A final FDA decision on the issue has been delayed indefinitely.

"The FDA can take centuries to make a new rule," said Peter Reichertz, a partner in Sonnenschein, Nath & Rosenthal's Washington, D.C., office who specializes in food and drug law. "Even with an expedited comment period, it still has to go through Health and Human Services and through the White House's Office of Management and Budget. There's nothing to stop the higher-ups in HHS from sitting on this as long as they want."

The FDA's announcement drew criticism and praise from doctors.

Physicians who support abortion rights and reproductive choice condemned the latest delay.

"It's unprecedented to have so many delays when the scientific evidence is so clear," said George Thomas, MD, a board member for the 6,600-member Physicians for Reproductive Choice and Health. "This appears to be yet another stall tactic that puts politics ahead of science.