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 — Posted 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.
"To continue stalling," Dr. Thomas said in a statement, "the FDA ignored 15,000 pages of solid clinical data showing that emergency contraception is entirely safe and highly effective, and that women need timely access to it. Stalling and delays only lead to more unintended pregnancies."
Joe DeCook, MD, a retired ob-gyn who is vice president of the American Assn. of Pro-Life Obstetricians and Gynecologists, praised the FDA for resisting "incredible political pressure from the feminist elite" to approve the change. "Making Plan B available over the counter would be a social and medical disaster, especially for teenagers," he said.
Dr. DeCook said some of his group's 2,500 members objected to Plan B on principle because they believe it sometimes acts as an abortifacient but said the group's official objections are much broader. OTC status, he said, would lead teenagers to have more unprotected sex, increase the prevalence of sexually transmitted diseases and discourage girls and young women from seeking regular care from an ob-gyn.
"These girls are not going to see a physician," Dr. DeCook said, arguing that an age limit was practically unenforceable. "They never have to be in the stream of physician care."
The AMA supports OTC status for Plan B. In 2004, the AMA House of Delegates condemned the FDA's refusal to approve Plan B for OTC status in spite of its staff's recommendation. In January, AMA Executive Vice President and CEO Michael D. Maves, MD, MBA, sent a letter to the FDA strongly urging it to approve Barr Pharmaceuticals' most recent application, writing, "Plan B meets all of the customary criteria for OTC availability."
OTC proponents, including some mainstream physician groups, accused the FDA of allowing its approval process to be compromised by political considerations.
"What this amounts to is a quintessential shell game in which women are the losers," said American College of Obstetricians and Gynecologists President Michael T. Mennuti, MD.
Days after the announcement delaying Plan B's OTC status, senior FDA official Susan Wood, PhD, resigned in protest from her post as director of the agency's Office of Women's Health.
"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," Dr. Wood said in a statement.
Dr. Crawford could have found a way to push the dual-status application through, attorney Reichertz said. For example, the FDA could have approved the age-split regime based on the notion that girls younger than 17 require additional counseling, he said.
"The FDA could have made a decision on its own about it," Reichertz said. "Quite frankly, I thought it was a political decision. I think that they could have taken the position that its use for a different age group is a different indication for use."
The FDA's August announcement is the latest in a 28-month string of delays that has frustrated proponents who say the OTC status would ensure that women could use the drug during the 12-hour period after intercourse when the medication is most effective.
Plan B, which functions by delaying ovulation and also might prevent fertilized ovum from implanting in the uterus, is 89% effective when taken within 72 hours of a single act of unprotected sex, according to a 1998 study in The Lancet.
An advisory FDA panel voted 23-4 in December 2003 to recommend that Plan B be made OTC for everyone. In May 2004 the FDA advised the drug's manufacturer, Barr Pharmaceuticals, that it could not approve the drug for girls because only 29 out of 585 test subjects were between 14 and 16 years old and none was younger than 14. Last month, the FDA's Center for Drug Evaluation and Research recommended that Plan B be made available OTC for women 17 and older, but by prescription only for girls younger than 17.
Carol Cox, a spokeswoman for Barr said via e-mail that the firm believes there's a solid legal foundation for the age-split regime. Cox also said Barr still believes, in spite of its recent application, that Plan B is safe and effective enough to be made available OTC to women of all ages. Asked whether the company would reapply for OTC approval without the age split, Cox said: "We will consider all options."