Evidence Trampled By Politics: Sebelius Overrides FDA Decision on OTC Emergency Contraception
[Originally posted at Our Bodies Our Blog. Speaking of, did you know the OBOS 40th anniversary edition book is one of Library Journal's Best Books for 2011 in the consumer health category?]
This week, Health and Human Services head Kathleen Sebelius interfered with the FDA’s decision that emergency contraception could safely be made available over the counter (OTC) without a prescription to women and girls of all ages.
The drug is already available without a prescription for women 17 and older, after years of political wrangling. Advocates have worked to ensure OTC access because emergency contraception is most effective when used as soon as possible, and time, distance, money, and privacy can be serious barriers to getting a prescription and obtaining the drug in time to prevent pregnancy.
The FDA’s Center for Drug Evaluation and Research (CDER) had completed a review of the issue and concluded that Plan B One-Step emergency contraception should be available OTC to younger women, which Commissioner Margaret Hamburg explains:
Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider…CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential.
That’s when Sebelius stepped in and blocked the findings of CDER from taking effect. In her letter [PDF] overruling the FDA’s findings, Sebelius objected that “The label comprehension and actual use studies submitted to the FDA do not include data on all ages for which the drug would be approved and available over-the-counter.”
That data is not available for the vast majority of over-the-counter drugs on sale to all age groups without a prescription. Many OTC drugs (like acetominophen and aspirin) can have serious, even fatal, effects if taken inappropriately because of deliberate misuse or misunderstanding the label and instructions. You will not find data on safety and label comprehension for every possible age group for these medicines, yet they are readily available OTC in adult doses to consumers of any age.
Former FDA official Susan Wood – who resigned after a previous round of political interference in emergency contraception – agrees:
“They don’t do this for pain medication, headache medication, cold medication,” she said. “That’s not part of how we assess products. Are we going to go and now do this with all products, or are contraceptives once again being singled out for this special treatment and this extra standard when we’re talking about a very safe and very effective product that can really help women?”
Change.org has a petition up urging Sebelius not to let politics trump science, and objecting to the HHS leader’s focus on very young girls who may access the drug:
The fact that the HHS and the Secretary are focusing on this extremely young age group is bizarre. Less than 1% of 11 year olds are sexually active, where over half of adolescents have had sex before their 17th birthday.
This decision is illogical and unfounded. Physicians around the country agree that Plan B is incredibly safe and effective for all ages, helping to decrease the number of unintended pregnancies.
This NPR coverage provides a succinct timeline and political explanation of the controversy over accessibility of emergency contraception.
Statement from Physicians for Reproductive Choice and Health stating that the Obama administration’s “put[ting] politics before science and responsible health policy…is appalling.”
Heather Corinna at Scarleteen urges young people to speak up in protest of this action.
Jodi Jacobson at RH Reality Check, who reminds us that the previous administration wasn’t the only one playing political games with reproductive rights:
…no amount of proof it seems can make up for the fact that, despite all the evidence, even President Obama and Secretary Sebelius appear to think young women are too stupid to make their own decisions or that they are just chum to be thrown to the religious right in an election year. As the saying goes, with friends like these, who needs the far right?
Added: Email the White House directly.
Also see Emily Douglas’s great piece for The Nation, which takes on the paternalistic BS of Obama’s response. Finally, see Susan Wood’s excellent piece in the Washington Post, where she writes:
The president should stand by the principles of scientific integrity and restore science to its rightful place. He should support the FDA commissioner and direct the secretary to allow the agency to do its job. By doing so he will fulfill the promise of that beautiful day in March 2009 when he pledged that science would trump politics, not the other way around.