December 8, 2011 — In an unprecedented move, HHS Secretary Kathleen Sebelius on Wednesday overruled FDA Commissioner Margaret Hamburg and rejected Teva Pharmaceutical Industries' request to allow sales of its Plan B One-Step emergency contraceptive without a prescription to people of any age, the New York Times reports (Harris, New York Times, 12/7). Plan B One-Step can prevent pregnancy and is most effective if taken within 72 hours after sex (Women's Health Policy Report, 12/6).
The decision means that Plan B will remain available "behind-the-counter" for purchase without a prescription by people ages 17 and older, while those 16 and younger will need to obtain a prescription (Petrochko, MedPage Today, 12/7).
Hamburg in a statement said FDA officials found "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" (Stein, Washington Post, 12/7). The agency was set to eliminate the current requirement that women prove they are at least 17 years old or obtain a prescription to purchase the drug, but Sebelius sent Hamburg a memo stating that the drugmaker's data did not show whether girls 11 and younger could use Plan B appropriately (Corbett Dooren, Wall Street Journal, 12/8).
Sebelius invoked her authority under the federal Food, Drug and Cosmetic Act to overrule FDA's decision (Bunis, CQ HealthBeat, 12/7). An FDA spokesperson said it is the first time an HHS secretary has publicly used the authority (New York Times, 12/7). An HHS spokesperson did not comment on whether the White House was involved in the matter but said "today's decision is the secretary's decision" (Wall Street Journal, 12/8).
Concerns About Data
Sebelius wrote that "it is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, which I believe are relevant to making this determination as to nonprescription availability of this product for all ages" (Sebelius, HHS memo, 12/7). Sebelius said Teva's studies on teens' label comprehension and actual use did not include data on all ages for which the drug would be approved for nonprescription distribution (Wall Street Journal, 12/8). She added, "The science has confirmed (Plan B) to be safe and effective with appropriate use." However, Teva did not present "enough evidence to show that those who use this medicine can understand the label and use the product appropriately," Sebelius said (MedPage Today, 12/7).
Women's health groups have long sought wider access to EC, first approved in 1999 for purchase only by prescription. Teva in 2003 sought approval to make Plan B available without a prescription, but the George W. Bush administration delayed a decision for three years amid protests from various lawmakers, women's groups and some officials within FDA that politics were playing a larger role than science in its decision.
FDA in 2006 approved the drug for "behind-the-counter" sales to women ages 18 and older. The agency later lowered the age to 17 after a federal judge ruled that its 2006 decision to limit access to women ages 18 and older was politically motivated and scientifically flawed.
Earlier this year, Teva submitted additional data to FDA detailing the actual use of the drug among young women ages 11 to 16 (Women's Health Policy Report, 12/6).
Women's Health Advocates, Medical Experts Criticize Sebelius' Decision
Many doctors, medical associations, women's health advocates and lawmakers were surprised and angered by Sebelius' decision, and they accused the Obama administration of being motivated by politics rather than science, the Washington Post reports (Washington Post, 12/7). For many, the move harkened back to the delays under the Bush administration (Fox, National Journal, 12/7).
Susan Wood -- who resigned as FDA assistant commissioner for women's health in 2005 over the agency's delay on over-the-counter approval for Plan B -- said, "As doctors and researchers have repeatedly stated, ample research shows Plan B to be safe for women of all ages and appropriate for over-the-counter access. It is deeply disappointing that this administration would repeat the mistakes of the previous one" (Rovner, "Shots," NPR, 12/8).
Wood noted that there are many drugs that pose greater risks and have not been studied in pre-adolescents but are available over-the-counter. "Acetaminophen can be fatal, but it's available to everyone," Wood said, adding, "So why are contraceptives singled out every single time when they're actually far safer than what's already out there?" (New York Times, 12/7).
Sen. Patty Murray (D-Wash.) in a statement said she is "very disappointed" in the decision, adding, "When it comes to the reproductive health of women, I've consistently said that we need to put science and medical evidence first" (CQ HealthBeat, 12/7). Rep. Diana DeGette (D-Colo.) said the FDA review process "was clearly extensive and thorough, and the data shared with HHS made clear that Plan B is safe and effective for its intended use" (Wall Street Journal, 12/8).
Planned Parenthood Federation of America said the decision will make it more difficult to lower teen pregnancy rates. Vanessa Cullins, vice president of external medical affairs for PPFA, said, "Multiple studies have shown that teens are as likely as adults to use emergency contraception correctly and that both groups report little if any difficulty using the method" (CQ HealthBeat, 12/7).
Nancy Northup, president of the Center for Reproductive Rights, noted that the group sued the Bush administration in 2005 for "rejecting science and playing politics with women's health by denying emergency contraception for over-the-counter sale," adding, "We are stunned to see the same behavior from the Obama administration" (Wall Street Journal, 12/8).
The decision "was clearly galling to medical experts," National Journal reports. The American Academy of Pediatrics, the American Congress of Obstetricians and Gynecologists, and the Society for Adolescent Health and Medicine issued a joint statement denouncing the decision (National Journal, 12/7).
Antiabortion-Rights Groups Praise Sebelius' Decision
Many conservative and antiabortion-rights groups welcomed Sebelius' decision, the Huffington Post reports. Kristi Hamrick, a spokesperson for Americans United for Life, said Sebelius "made the right call" (Bassett, Huffington Post, 12/7).
Jeanne Monahan, director of the Family Research Council, said, "There is a real danger that Plan B could be given to young women, especially sexually abused minors, under coercion or without their consent," if it becomes available without a prescription (Wall Street Journal, 12/8).