Feds don’t trust women to read birth-control directions

The U.S. Food and Drug Administration could be on the verge of reversing decades of misguided precedent surrounding women’s use of long-available birth control pills. This would be a welcome change, given that the drug-regulating agency that hasn’t historically trusted women to manage their own healthcare.

This development stems from a recent meeting of an FDA panel of advisors who unanimously recommended approving over-the-counter (OTC) access to a particular birth control pill known as Opill. The drug is far from new. It has been on the market since 1973 and, like many other contraceptive pills, it relies only on the hormone progestin, which is a tried and true form of birth control. Despite this, it has been available by prescription-only for decades, but there’s reason for cautious optimism that this could change and greatly benefit women in Georgia and across the country.

“The panel seems very comfortable with the limited number of risks from the medication itself,” the FDA panel chairwoman said. “The panel expresses confidence in the effectiveness, not only in the general population of females, but also in adolescent populations and those with limited literacy.”

Within a matter of weeks, the FDA will decide whether or not it should become the nation’s first OTC birth control pill. This would be a huge step in the right direction that would expand access to contraception and open the door to similar drugs gaining OTC approval, but hurdles still exist.

While the FDA often follows advisory panels’ advice, the agency isn’t required to do so, and it appears that there are some naysayers in the agency. “The FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively at the nonprescription setting,” responded Dr. Karen Murry, deputy director of the FDA’s office of nonprescription drugs.

“We can’t just approve it based on the experience in the prescription setting without the applicant doing adequate studies to look at what’s likely to happen in the nonprescription setting,” Murry continued. Translation: The FDA isn’t sure that women can be trusted to follow directions. Of course, it is always wise for the regulatory agency to do its due diligence, but approving Opill and others for OTC access seems like a no-brainer.

The first oral contraceptive pill was introduced in 1950, and myriad others have since followed. What’s more, roughly 90 percent of women have used birth control at some point—meaning the FDA has over 70 years’ worth of research and millions of individual case studies to make a determination. While far from an apples to apples analogy, compare that to the COVID-19 vaccine that the FDA granted emergency approval within a matter of months and with much more limited data.

No medication is without some degree of risk, but hormonal birth control has proven to be remarkably safe and well-tolerated by most women. In fact, the American Medical Association, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians have all endorsed OTC access for hormonal contraception.

If the FDA still wants more data on expanded access to birth control, there’s plenty of it here and abroad. To begin with, hormonal contraception pills are available OTC in more than 100 countries, and inaction from the FDA on birth control over the years has spurred states to take matters into their own hands. To date, 26 states and the District of Columbia permit pharmacists to dispense self-administered hormonal contraception to qualifying customers without a prescription from a doctor. Georgia is conspicuously absent from this list even though the policy has been successful.

States have the power to adopt the pharmacy access model for birth control, but they do not have the power to make it OTC. Only the federal government has that authority, but the FDA’s long-held opposition to OTC access seems increasingly untenable.

According to the Guttmacher Institute, around 45 percent of U.S. pregnancies are unplanned, which cost taxpayers around $21 billion in 2010, and teen pregnancy—while declining—remains stubborn. Moreover, the nation is grappling with a maternal mortality problem. For every 100,000 live births, about 24 mothers die.

The maternal mortality and unplanned pregnancy rates are even higher in Georgia, but it stands to reason that increased access to birth control could help alleviate these problems in the Peach State and across the country.

Considering the abundance of data, research and case studies, the FDA has little reason to block OTC access to self-administered hormonal birth control unless regulators simply don’t trust women. Clearly the advisory panel believes that the benefits of increased access far outweigh the risks and women are more than competent to safely use this medication. Hopefully, the FDA will agree, despite years of obstinate behavior.