HHS Blocks Expanded OTC Access to Plan B One-Step

HHS Secretary Kathleen Sebelius' recent decision to countermand FDA approval of OTC access to a specific emergency contraceptive for girls younger than 17 may have closed the door for now on the regulatory aspects of this issue, but it has reopened discussion of the topic among some family physicians.

The FDA's approval of an expanded indication for the single-dose levonorgestrel tablets marketed as Plan B One-Step was slated to be announced on Dec. 7. The expansion would have made the drug available OTC to all girls of reproductive age. Instead, Sebelius effectively pulled rank on FDA Commissioner Margaret Hamburg, M.D., announcing (2-page PDF; About PDFs) that, in her view, the data supporting the OTC release were not sufficient.

FPs' reactions to the secretary's last-minute move are mixed.

Inis Bardella, M.D., of Libertyville, Ill., said she agrees with Sebelius' decision -- but for what she described as "broader and deeper reasons" than a lack of research evidence.

"The consideration of any contraception -- especially emergency contraception -- requires discussion with, and education by, a physician who not only understands the pharmacology, risks and potential harm of the intervention, but also can understand the patient, including all the factors influencing her consideration of contraception and participation (voluntary or forced) in sexual activity," said Bardella. "Preferably, the physician is a primary care physician who knows the patient already.

"Avoiding harm to the woman, and addressing sexual abuse or coercion are always concerns, and even more so in girls and teens -- these must be discussed. I also remain in objection to emergency contraception being available without a prescription for anyone for all of these same reasons."

On the other hand, Judith Chamberlain, M.D., of Brunswick, Maine, said she is disappointed by the decision because, in her view, HHS ignored an evidence-based recommendation and put young women at risk.

"This administration promised that it would base such decisions on sound science and what's in the best interest of women's health," Chamberlain said. "They failed in this instance. The FDA recommendation would have been an opportunity to improve young women's access to contraception, which is the best way to reduce the need for abortion."

Jack Chou, M.D., of Baldwin Park, Calif., said he also is disappointed in what he perceives to be a politics-over-evidence decision and stressed that it is even more important now for doctors to communicate openly with their patients.

"Secretary Sebelius' action simply reinforces the need for family physicians to fully discuss all family planning options available and to support personal decisions made by our patients of reproductive age," Chou told AAFP News Now.

The respective FDA and HHS releases that followed the decision split along similar lines, with Hamburg pointing to study findings vetted by the agency's Center for Drug Evaluation and Research as reasons for approval and Sebelius disputing that conclusion.

"I reviewed and thoughtfully considered the data … and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential," Hamburg said in a statement posted on the FDA website.

In her letter, Sebelius stressed that her decision did not change the current availability of the drug but said that the data from Teva Pharmaceuticals, the maker of Plan B, did not warrant granting expanded OTC access.

"It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age," Sebelius said. "Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application."

For its part, Teva thanked the FDA for recommending greater OTC access and took issue with Sebelius' timing.

"We are disappointed that at this late date, the Department of Health and Human Services has come to a different conclusion," Teva said in a statement. "We will review the letter when we receive it and then determine our next steps."