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Will the Supreme Court Spur OTC Contraceptive Development?


Pharmaceutical Executive

One piece of fall-out from the recent Hobby Lobby decision by the U.S. Supreme Court is to generate talk of Republicans backing development of a nonprescription contraceptive pill.

One piece of fall-out from the recent Hobby Lobby decision by the U.S. Supreme Court is to generate talk of Republicans backing development of a nonprescription contraceptive pill. Conservative commentators supported this strategy as a way for Republicans to deflect Democratic charges of a GOP “war on women” and access to safe and effective birth control.

Evidently Louisiana’s Republican governor Bobby Jindal has voiced support for legislation allowing oral contraceptives to be available over-the-counter, and some Republican candidates find the issue plays well locally. A “Vox” blog posted June 30 (www.vox.com) supports such action, noting that oral contraceptives are safe, that the morning-after pill is available OTC, that there’s ample evidence that women can self-screen for risk factors, that eliminating the need to see a doctor will broaden access, that contraceptives are available without prescription in much of the world, and that the switch would save money for everyone.

Such a move, though, would align conservatives with a spectrum of women’s health advocates and researchers who have been pressing for OTC contraceptives for years. FDA has examined the issue recently as part of its ongoing effort to fix its cumbersome regulatory process for bringing new nonprescription products to market. The agency held meetings in March 2012 on using innovative technologies to expand nonprescription drugs – eliciting comments from consumer, industry and medical experts on how better access to Internet information enhances self-diagnosis and safe use of various medical products, including contraceptives. The decades-old effort at FDA to finalize its monograph review process for OTCs has attracted attention from Congress, which has joined industry in pressing FDA to move forward, namely to approve more effective sunscreens.

Members of the Oral Contraceptives (OCs) OTC working group testified at the FDA meetings and recently summarized their efforts in an article in the March 2014 Food and Drug Law Policy Forum on “Should Oral Contraceptives Be Available Over the Counter?” (available at www.fdli.org). The article by David Grossman and colleagues at Ibis Reproductive Health makes the case for the safety and benefits of oral contraceptives and that better access to a low-cost pill might reduce the vast number of unwanted pregnancies in the U.S.

But FDA’s history approving nonprescription contraceptives does not support optimism for any fast action. Rule making needed to approve OTC vaginal contraceptive gels took more than 20 years. Approval of the Plan B emergency contraceptive was so controversial and buffeted by political forces that it took lawsuits and court orders for the agency to make the product available without prescription to all women. Safety issues related to OCs in recent years have led to boxed warnings on some birth control pills linked to a higher risk of blood clots and to advise against use by smokers and patient with high blood pressure.

An OTC pill that would be used long-term and possibly without much medical supervision will require extensive data, oversight and broad public support. But in the Washington world of strange bedfellows, it could happen that conservatives eager to reduce government control over individual health decisions might find common ground with women’s health advocates, and that some brave pharmaceutical company will take the risk to develop such an important product that meets these needs.

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