FDA Finally Approves One Brand Only Of Birth Control For OTC Use – Experts Believe All Should Be OTC

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FDA Finally Allows OTC Access to One Brand of “Minipill”—A Mini‐​step in the Right Direction

By Jeffrey A. Singer

The Food and Drug Administration announced this morning that it has granted marketing approval for the over‐​the‐​counter sale of one type of birth control pill, a progestin‐​only pill (also called the “minipill”). As explained here, the minipill is not as easy to use as combination oral contraceptives. Dublin‐​based Perrigo, the maker of the pill that will have the brand name Opill, states it hopes to have the pill on the market by 2024.

As Josh Bloom and I wrote in May, enabling women to access this one brand of minipill is a ministep in the right direction. But the FDA should allow all women to access all forms of hormonal contraception over‐​the‐​counter. Below is a prior article on this topic:

FDA Might Approve Over‐​the‐​Counter Sales of One Birth Control Pill. Now It’s Time To Approve All the Rest

Why won’t the FDA allow women to buy a safer product without requiring a doctor’s visit that medical experts think is unnecessary?

MAY 10, 2023 • COMMENTARY
By Josh Bloom and Jeffrey A. Singer
This article appeared in Reason on May 10, 2023.

For decades, the American College of Obstetrics and Gynecology, the American Academy of Family Physicians, the American Medical Association, and the vast majority of practicing reproductive physicians have called for the Food and Drug Administration (FDA) to make hormonal contraceptives (e.g., birth control pills) available over the counter (OTC) to women of all ages.

When experts in the field who get paid for prescribing hormonal contraceptives nonetheless keep telling patients, “You don’t need to see me for this,” government regulators should take notice. Women can get birth control pills OTC in over 100 countries, formally or informally, around the globe. It’s time for them to be OTC in the “land of the free.”

The FDA might soon give access to a type of birth control pill that has been available only by prescription since 1973; in fact, today, an FDA panel voted unanimously to make birth control pills available OTC. But here’s a catch: women will only have access to one brand of one kind of birth control pill, a progestin‐​only pill sometimes called the “mini‐​pill.”

Unlike regular birth control pills, which contain two female hormones, estrogen and progesterone, the mini‐​pill doesn’t affect milk production in nursing mothers and is less likely to cause blood clots in women who smoke. To put this in perspective, pregnancy is more likely to cause clots than any pill to prevent it.

But, the mini‐​pill, while it may be slightly safer to use than other birth control pills, has drawbacks.

For example, the mini‐​pill only works if women take it at the same hour daily. If they take it more than three hours late, women must use another contraceptive for the rest of the month and start the cycle again. The same is true if they miss a day. With regular birth control pills, if women miss a day in the cycle, they can take two pills the following day.

While better than the status quo, the FDA shouldn’t restrict women’s OTC options to safer progestin‐​only pills, not to mention one progestin‐​only product. Unlike regulators in, say, Portugal, Brazil, or Mexico, the FDA doesn’t think American women can weigh the risks and benefits of various birth control pills and decide which is best for them—even if reproductive specialists believe they can.

Further mitigating drug‐​related side effects is that women may be more cautious than doctors in choosing the best drug for themselves. A 2006 study asked women to self‐​assess birth control pills. Ninety percent of the time, doctors agreed with their assessment, and 10 percent of the time, women were more conservative than doctors.

In 2013, the FDA approved OTC access for women of all ages to emergency contraception—the so‐​called “morning‐​after pill.” The most well‐​known emergency contraceptive is called “Plan B.” The fact that it is available OTC while “Plan A” (birth control pills) is not, defies logic.

The reason? Dose. There is much more progestin in Plan B pills. This becomes obvious when considering that standard birth control pills can also be used for emergency contraception. When used as such, the required dose is 8–10 pills. It isn’t easy to imagine a logical scenario where a pill containing a 10‐​fold dose of progestin (Plan B) should be readily available to women of all ages while a single, low‐​dose pill taken daily is not.

Furthermore, far more dangerous OTC drugs are available to women–and children–without any FDA restrictions whatsoever. Acetaminophen (Tylenol) accounts for 56,000 emergency room visits and 500 deaths annually. In 2018, 27,000 people overdosed on salicylates, primarily aspirin, with a mortality rate of 0.4 percent. Between 2011–16 Benadryl was involved in 3 percent of all drug overdose deaths. It defies logic that a 10‐​year‐​old can purchase any of these drugs in a pharmacy or supermarket while women are forced to see a physician for a script for a far safer drug.

Why won’t the FDA allow women to buy a safer product without requiring a doctor’s visit that medical experts think is unnecessary? The time has come for the FDA to make all birth control pills—not just one “mini-pill”—over the counter.

ABOUT THE AUTHORS
Josh Bloom

American Council on Science and Health

Jeffrey A. Singer

Senior Fellow, Cato Institute


Banner Image: Oral contraceptives. Image Credit – No Revisions


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