It was on May 9, 1960 that the Food and Drug Administration approved the application of G.D. Searle & Co. to market the first ever oral contraceptive pill.
Retailed as Enovid® on a prescription-only basis, the new entry was to afford women unprecedented control over their reproductive destiny. For the first time in human history, female reproductive autonomy was finally at hand and sexuality was no longer equated with maternity. A key milestone in the long struggle for the emancipation of women, the debut of the “pill” was a watershed moment the likes of which are rarely encountered.
Six decades later, however, the “pill” has yet to deliver on its warrant to render unintended pregnancies a thing of the past. Nearly half of all pregnancies in the United States are still unintended. Many are attributable to the anachronism of prescription-only oral contraception long known to foment lapsed prescription refills. It follows that the age-old linkage of prescription renewal to a physician office visit is no longer sustainable. The time for unimpeded access to prescription-only contraceptives is now. Diminishing, if not eliminating, the prospect of unintended pregnancies will require nothing less. Most developed nations have crossed this bridge to great effect.
Many politicians have considered the notion of doing away with prescription-only oral contraceptives and there have been a number of federal legislative initiatives. Regrettably, however, congressional efforts to encourage swift approval of over-the-counter oral contraceptives by the Food and Drug Administration have been mired in politics and have repeatedly fallen flat.
The partisan congressional efforts have been hamstrung by disagreements over how the Affordable Care Act’s contraception coverage provision would apply and potential age restrictions for access. Of course, any action by Congress to increase access to over-the-counter oral contraception is purely theoretical without pharmaceutical companies submitting applications to the Food and Drug Administration.
To date, not one pharmaceutical house has embarked on the arduous regulatory track presently required for the abolition of the prescription requirement. But there are some signs of hope. Even so nascent efforts are presently underway to secure the approval of the Food and Drug Administration for a novel over-the-counter oral contraceptive.
Mindful of the stalled efforts at the national level, several states have taken matters into their own hands. These state initiatives were consonant with both the letter and spirit of the “contraceptive mandate” of the Affordable Care Act wherein the challenge of unintended pregnancies featured prominently. Some states have taken to directing private health insurance plans to underwrite a full year’s complement of birth control pills in the name of minimizing lapsed prescription refills. Yet other states have taken to empowering pharmacists to prescribe and/or dispense approved combination oral contraceptives absent the intermediacy of a physician. While follow-up studies of these state efforts are still preliminary, an early downward trend in the incidence of unintended pregnancies is suggested.
Over-the-counter access to hormonal contraception will improve availability, but it should not be at the expense of affordability. Insurance coverage and other financial support for contraception should still apply. Each woman should be able to select the contraception that works best for her, including over-the-counter hormonal contraceptives, a long-acting reversible contraceptive provided by her health care professional, or other methods. Women should be able to consult with their physician or health care professional to address underlying health concerns, whether related to contraceptive care or their overall health.
Access to contraception — with or without a prescription — is also at risk due to efforts by the current administration to allow more employers to deny no-copay coverage of contraception and state and federal efforts to limit access to family planning providers that offer comprehensive reproductive health care, including via the Title X Family Planning Program and Medicaid. While we continue to set our sights high for the future of oral contraception and its potential to further reduce unintended pregnancy rates, we cannot lose the valuable gains we’ve fought for decades to achieve.
For all its undeniable achievements, the “pill” has yet to live up to its promise to contend with the reality of unintended pregnancies. Doing away with the prescription-only imperative has yet-to-be accomplished. The American College of Obstetricians and Gynecologists calls for “over-the-counter access to hormonal contraception without age restriction.” A comparable position was taken by the American Academy of Family Physicians. Policymakers and the pharmaceutical industry should follow suit.
Improved access to contraception should not be partisan and should be cheered by all. Only in so doing, will the United States be joining the ranks of other developed nations, and not a moment too soon.
Eli Y. Adashi, MD, MS, is professor of Medical Science and the former dean of Medicine and Biological Sciences, Brown University, Providence, RI. Eva Chalas, M.D. FACOG, FACS is president of the American College of Obstetricians and Gynecologists. Kunal Sindhu, MD, is a doctor and has been published in the Journal of the American Medical Association.