In a surprising moment of bipartisan unity, Republicans and Democrats seem to be in agreement that it's time to remove the prescription requirement for oral contraceptives. Right before Memorial Day, Sen. Kelly Ayotte (R-N.H.) and Sen. Cory Gardner (R-Colo.) introduced legislation aimed at making birth control pills available over the counter, and now Sen. Patty Murray (D-Wash.) has introduced a Democratic bill that also would add insurance coverage for a future OTC pill. Though the politics of these moves tend to get the disproportionate share of attention, it's worth exploring what the impact of either bill would be for women.
Since 2004 I've led a coalition of researchers, doctors and women's health advocates exploring the feasibility of making birth control pills available without a prescription.
The science on this is clear: The pill is one of the best-studied medicines on the market today, and it's certainly safe enough to be available without a prescription. Some women have conditions that might make it more risky to take the pill, but studies show that women can use simple checklists on their own to figure out whether the pill is right for them. Other research shows that women getting the pill over the counter stay on it longer than women getting it by prescription. Major medical societies, including the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians, support OTC access to the pill.
So do women. Studies show they are very interested in getting over-the-counter access to birth control pills, including about a third of women who currently don't use any birth control but are sexually active and don't want to get pregnant. This suggests that the OTC pill could lead to more women using effective contraception, with fewer gaps in use, which could help reduce unintended pregnancies.
But changing the pill from prescription-only to over-the-counter is no small feat, and it will require an interested pharmaceutical company with deep pockets. The research required by the Food and Drug Administration to consider such a change in status is costly. The Republican bill aims to motivate pharmaceutical companies by expediting the review process and waiving the FDA filing fee, which is at least $1 million.
There's another reason companies may hesitate to go forward with over-the-counter birth control pills: fear of political interference — and the costs and uncertainty it introduces — in the FDA approval process. When Plan B emergency contraception was being considered for over-the-counter sale, politicians of both parties intervened in the process, slowing it down and imposing an unreasonable age restriction, one that was lifted only after a 10-year legal battle.
Unfortunately, the bill introduced by Ayotte and Gardner would also interfere with the FDA process. It would give priority FDA review and waive the filing fee only for an OTC pill to be sold to those older than 17. From a medical point of view, there is no more reason to prohibit adolescents from getting birth control pills without a prescription than to bar them from buying over-the-counter cough syrup. Research shows that allowing teens access to emergency contraception without a prescription has not led them to engage in riskier sexual activity. Adolescents often have their first sexual encounter before seeing a doctor or nurse to discuss contraception, and over-the-counter birth control pills could help reduce the high teen pregnancy rate in the U.S.
There are other issues with the age restriction in the Republican bill. Anyone trying to buy the pill over the counter would need to show proof of age. Many people with the most to gain from the non-prescription pill — including undocumented immigrants ineligible for many programs that support family planning services — may not have a government-issued ID. The age restriction also creates extra work for pharmacists, who have to keep the product behind the counter so they can screen buyers. This, in turn, increases the cost of the pill and limits access to it.
Concerns about the cost of a future OTC pill are real, since insurance generally covers OTC contraceptives only if a woman has a prescription. The two bills diverge significantly when it comes to helping people pay for the pill. The Republican proposal offers a half-hearted solution: People can use pretax dollars in flexible spending accounts or health savings accounts to buy over-the counter medications without a prescription (the prescription requirement was imposed under the Affordable Care Act).
But this move is unlikely to help women who struggle to pay for birth control. Murray's bill is better; it would extend the contraceptive coverage guarantee under the Affordable Care Act to include the FDA-approved over-the-counter pill. (Several state Medicaid programs already do this, providing a model for making sure every woman has affordable access.)
Over-the-counter access to the pill could be a game-changer for public health, eliminating an unnecessary barrier to a highly effective form of birth control. The support of politicians from both sides of the aisle to help make this a reality is welcome. But politicians must stay out of the drug regulatory process and let the FDA do its job.
Daniel Grossman is an obstetrician and gynecologist, a clinical professor at UC San Francisco, and vice president for research at Ibis Reproductive Health, a nonprofit research organization. www.OCsOTC.org and www.freethepill.org