You may have heard by now that yesterday afternoon U.S. Secretary of Health and Human Services Kathleen Sebilius overrode the recommendation of the Food and Drug Administration to make Plan B One Step emergency contraceptive available over the counter without prescription to all women. Per Sebilius’ decision, those under the age of 17 will continue to need a prescription to obtain emergency contraception. According to reports, this is the first time on record that a HHS Secretary has utilized her authority to veto a recommendation made by the FDA.
The first question you might have is how did this happen, and why does Sebilius get to decide against the scientifically-based recommendations of the FDA scientists? To understand that, you need to understand how the U.S. bureaucracy works. The Secretary of the Department of Health and Human Services is a member of the President’s Cabinet. There are fifteen Cabinet portfolios, each headed by a Secretary, and about a half dozen or so other Cabinet-level offices. These people report directly to the President. All of the other federal agencies and administrative offices fall underneath one of the Cabinet portfolio areas. So even though the FDA is a pretty important office that plays a critical role in the health and well-being of the American public, it’s a sub-department within the organizational structure of the Department of Health and Human Services. Although Commissioner Margaret Hamburg is at the top of the FDA food chain and gets to make the final recommendation, ultimately the buck stops with Sebilius, who makes decisions for all of those agencies on the organizational chart at the link.
With that out of the way, what happened? Despite some well-researched reports provided to the FDA, Sebilius was concerned that very young women wouldn’t be able to figure out how to use Plan B correctly. According to a study that a couple of articles have cited but still hasn’t been made available to the public, 90% of young women between the ages of 11 and 17 were able to use emergency contraceptive correctly under simulated real-world conditions. With One Step in particular, that’s not surprising! You… take the pill. And brace yourself if you’re susceptible to cramps or headaches as side effects from hormonal birth control. That’s about it. Further, as some have noted, plenty of other drugs have not had their over-the-counter approval predicated on common correct usage. (Which is certainly true if my over-dosage of ibuprofen is any indication, but that’s probably a story for another day.)
The New York Times interviewed Assistant Dean Kathleen Hill-Besinque of the University of Southern California School of Pharmacy on the topic. She commented:
Very few medications are this simple, convenient and safe.
Most scientific researchers interviewed in the various media outlets I’ve been scouring since the news broke have come to the same conclusion. And the drug has already been available over the counter to women 17 and older for some time. It’s the religious community organizations praising Sebilius for protecting young women, citing social and family reasons. Most people across the political spectrum seemed shocked by Sebilius’ decision.
The fact is, while emergency contraceptive works for up to 72 hours, the sooner women take it, the more effective it is. By forcing young women – who already face barriers of access to contraceptive and reproductive care – to get a prescription, the government is taking Plan B off the table for a lot of people.
Note: You can download a coupon for $5 off Plan B here. (Teva Women’s Health did not provide me any compensation for passing that link along.)