The FDA is allowing women over-the-counter access to one brand of one form of birth control pill. But the agency should follow the advice of medical experts and let women exercise their right to self-medicate with all hormonal contraceptives.
On July 13, the Food and Drug Administration (FDA) finally allowed women to access one birth control pill over the counter. The FDA signaled in May that this was likely to happen after an advisory panel recommended that the agency approve over-the-counter marketing of the progestin-only oral contraceptive Opill, manufactured by the Dublin-based Perrigo Company. Progestin-only oral contraceptives have been around since 1973. Dubbed the "mini pill," these contraceptives have their limitations.
For example, women must take the pill at the same time every day, within a three-hour window. If they miss the window, they must discontinue the pill and begin again with the next cycle. With standard birth control pills that combine estrogen and progesterone, women who miss a daily dose can double up the next day. Women who take progestin-only pills have a slightly lower risk of developing blood clots that can break off and travel through the body (venous thromboembolism, or VTE) than they do with combination pills. But the American College of Obstetricians and Gynecologists (ACOG), which has for decades advocated making all hormonal contraceptives available over the counter for women of all ages, states the risk of VTE "with combined oral contraceptive use is small compared with the increased risk of VTE during pregnancy and the postpartum period."
ACOG is not the only medical professional organization calling to free the birth control pill. It is joined by the American Academy of Family Physicians and the American Medical Association. And most reproductive health care providers surveyed in 2016 favored over-the-counter birth control pills. These medical experts, who get paid to evaluate women and prescribe hormonal contraceptives, have the financial incentive to argue for maintaining the status quo. When they repeatedly assert that women do not need their services to obtain birth control pills, regulators should take notice.
The FDA approved over-the-counter emergency contraception, the so-called morning-after pill, for women of all ages in 2013. These pills (for example, Plan B) usually contain high progestin levels. But standard birth control pills can also be used for emergency contraception. The required dose is 8-10 pills. The FDA denies women over-the-counter access to contraceptives with one-eighth to one-tenth the potency of over-the-counter emergency contraceptives.
In a Cato Institute white paper, Director of Health Policy Studies Michael F. Cannon and I pointed out that birth control pills are available in more than 100 countries without a prescription. In a January 2020 Los Angeles Times column, we explained that switching a drug from prescription-only to over-the-counter status typically causes its price to fall. But don't expect prices for the mini pill to fall soon. Because the FDA will only allow women to purchase this one brand of mini pill without a prescription, it will be shielded from price competition by rival brands.
Minors can buy lethal amounts of acetaminophen and ibuprofen without a prescription. Yet adult women must get a permission slip from another adult to exercise the right to contraceptive self-medication. And we other adults—licensed health care clinicians—think the requirement is preposterous.
The FDA took a mini step in the right direction by allowing women over-the-counter access to one mini pill. But Americans should not be satisfied until all forms of hormonal contraception are set free from the government's yoke.
#Reprinted with permission from Reason Magazine. The original post can be read here.
