The U.S. Food and Drug Administration has finally approved an over-the-counter hormonal birth control pill.
At a time of unrelenting attacks on reproductive autonomy, the Food and Drug Administration’s decision on July 13 to approve a birth control pill for over-the-counter (OTC) use is an important advance toward providing people with tools to control their fertility. This includes preventing unwanted pregnancy. Having Opill, a safe, effective, easy-to-use birth control option available without a prescription is essential, because it so difficult for many people to get prescription birth control in the U.S.
Two months ago I blogged about the FDA advisory panel recommending approval here, saying:
An advisory panel of the U.S. Food and Drug Administration (FDA) voted to recommend Opill be sold over the counter (OTC) without a prescription. Opill is a hormonal contraceptive pill first approved in 1970. Advisory committees are panels of outside medical experts who advise the FDA on matters related to the specific area they were appointed to. There are numerous advisory panels. In the latest vote, one panel advises on over-the-counter medications. Another panel advises on reproductive health. The combined panel was composed of 17 experts in a 2-day hearing.
I even authored a policy brief back in 2015 advocating OTC birth control pills:
The idea of selling birth control pills over the counter has been around awhile and garners significant support. In a large survey of health providers, social services, academic researchers and advocacy organizations, more than half were “strongly in favor,” while 86 percent where either strongly in favor or somewhat in favor of allowing access to oral contraceptives over the counter. Both Planned Parenthood and the American College of Obstetricians and Gynecologists (ACOG) believe oral contraceptives are safe enough for OTC access and have supported the idea under various conditions. The debate has moved beyond health safety concerns to the question of who will pay for these contraceptives.
The FDA and pharmacists must make the pills available on shelves rather than behind the pharmacy counter.
Perrigo must make this pill affordable.
Their concern is that Opill needs to be both accessible and affordable. They are correct but they do not understand the economics behind why they’re correct. Indeed, one of the many misguided arguments made against approving an oral contraceptive for over-the-counter sales is that contraceptives are already mandated through ACA health plans, as well as though most employer plans. A misguided complaint sometimes made is that OTC medications are not covered by insurance and a health plan may try to force women to use their own money to buy Opill rather than making Aetna, Blue Cross or Cigna pay for a more expensive brand. That logic is incorrect as I explained in my 2015 issue brief:
Allowing sales of hormonal contraceptives over the counter without a doctor’s prescription would benefit millions of women. Prices for prescription drugs fall by 90 percent or more within months of losing patent protection and becoming available over the counter. Oral contraceptives would likely follow the same trajectory.
Once a Rx drug goes generic and is approved for over-the-counter sales, its price falls by up to 97% over time as it faces competition from other generic OTC drugs. The key to making oral contraceptives cheap and accessible is for the FDA to signal to competing drug companies that the federal agency is receptive to switching their birth control products to OTC as well. Once there are several competing OTC contraceptives on the market, especially if they’re released in generic versions, prices will plummet.
It is also important that these products not be legally restricted to behind-the-counter. That too can reduce competition. A 2005 federal law requires pseudoephedrine to be sold only behind the counter. My wife’s preferred allergy medication is generic Allegra D, which because of the D must be sold behind the counter. As a result, it’s hard to find at a good price on products containing the decongestant. The cheapest I’ve found fexofenadine with pseudoephedrine (generic Allegra D) is $0.45 cents a pill at Walmart. Every Walmart in my area has been out of it for the past four months. I bought the generic Allegra D at Krogers and it was $0.90 cents a pill. By contrast generic fexofenadine on Amazon is as low as $0.13 cents a pill. Were it not for laws that reduced competition, generic Allegra D would most likely be close to the generic price for fexofenadine on Amazon.
It’s great news for both men and women that the FDA has approved an OTC oral contraceptive. Now it’s up to regulators to make it accessible and cheap, something they have the power to do by allowing competition to flourish.