via Newsweek, which reports on the work of the Over-the-Counter Oral Contraceptives Working Group. As it so happens, this is not the first time this question has been asked — something I’m exploring in an article I’m revising for a edited volume on The Prescription in Perspective: Therapeutic Authority in Late 20th Century America edited by Jeremy A. Green and Elizabeth Siegel Watkins for Johns Hopkins University Press. Historically, the arguments in favor have tended to come from public health experts who see the prescription as paternalistic and an unnecessary barrier to timely access. This is the position taken by Kathleen Reeves at RH Reality Check, who says that the prescription “seems like a holdover from the days when contraception was forbidden: when women who wanted it were reprimanded and those who provided it were jailed.”
[P.S. here’s another article on this same subject from RHReality Check].
Meanwhile, Elizabeth Kissing over at the Society for Menstrual Cycle Research’s blog re:Cycling has this to say:
“I have mixed feelings, myself. I’m in favor of just about anything that makes contraceptives more accessible to the people who need them, but I fear that the likely increase in cost of OTC pills means the availability won’t benefit those who most the need them – the young and the poor. Also, there are some contraindications for pill use, such as high blood pressure, history of migraine, and use of certain anti-seizure drugs for epilepsy. And despite the happy, shiny images of Yaz and Seasonique commercials, some women just can’t tolerate the side effects, for any number of reasons.”
This is pretty much the argument that was made by the National Women’s Health Network and other consumer protection groups the last two times this issue was raised — in 1993, and again in 2000. Despite claims by FDA Center for Drug Evaluation and Research direct Phillip Corfman that the Pill was “safer than aspirin” and should therefore be sold over the counter, these consumer protection advocates argued that the pill was just too dangerous for OTC use.
Now the issue has come up again, no doubt because the success in getting emergency contraception sold, well, not quite OTC, but at least behind the counter without a prescription. The OTC OCs working group includes representatives from NWHN and others who were against nonprescription status for birth control pills. It will be interesting to see how this develops, and whether it will get in my paper. Now, this is the problem with doing very recent history — the history keeps on happening while you’re writing it and there are continual updates!
According to the OTC OCs Working Group’s July newsletter, the Newsweek article does a nice job of summarizing the issue, but here are some corrections:
- Regarding the timeline for an OTC switch, the article says, “They hope to have a proposal before the FDA within the year and an over-the-counter pill available in five years.” When I spoke with the author, I said that we hoped to have a meeting within a year (and hopefully this year) with the FDA to get feedback on the draft study protocols and labeling the working group has developed. The actual use and label comprehension studies would need to be completed before an application could be submitted, and those studies will take time–and additional funding. The working group is still in the process of exploring partnerships with pharmaceutical companies, since such a company would likely be the sponsor of a switch application to the FDA. I also said that the five-year goal of having an OTC pill on the market depended on a lot of factors, including an assurance that low-income women would be able to access such a product.
- The article confuses the FDA advisory panel’s recommendation on the EC product ella with an actual approval, and incorrectly describes ella as containing progestin when it is composed of ulipristal acetate.
- The article misquotes the Pharmacy Access Partnership’s national survey, which asked women about pharmacy access to hormonal contraception, rather than OTC access.
- The article references our paper on contraindications among Mexican OC users, but that paper did not find “that women who buy pills directly from pharmacies often have greater understanding of the contraindications than women who visit clinics.”
- The working group is currently supported by a grant from the Hewlett Foundation, which is misspelled in the article.
So, what do readers out there think? Should women be freed from the tyranny of the prescription? Or do we need the Rx to protect us from unsafe products? [remember there’s a class action lawsuit against the manufacturers of Yaz and Yasmin filed by women who have suffered strokes and blood clots and other serious side effects)?
On balance, I’d like to see it go OTC. The price of it would be my main concern. And the price issue also intersects with the Mikulski bill – would nonprescription birth control stand *any* chance of being fully covered under it?
I’ve read more than once that aspirin wouldn’t be approved today as an OTC product; it has too many risks. But is the pill safer than ibuprofen? Safer than Tylenol (which has come under regulatory attacks, itself, though I think they’re mainly a smokescreen for paranoia about opioids)?
Why not approve versions of the pill that have been on the market for long enough to have a solid safety profile (e.g., 15-20 years or more), while keeping newer versions still on prescription? That might be a solution for issues raised by Yaz/Yasmin: As long as a drug is prescribed, you can track post-approval safety issues. Such tracking becomes largely impossible for OTC substances.
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Thanks for your comments, Sungold. My understanding is that the working group is seeking to get an application for a low progesterone “mini-pill” with a good long-term safety profile before the FDA soon.