FDA Moves One Step Closer To Switching An Oral Contraceptive From Prescription-Only To Over-The-Counter Status

Today, during a Food and Drug Administration (FDA) advisory committee meeting, a panel of independent experts voted unanimously 17-0 that the FDA should approve the first over-the-counter birth control pill.

The Irish firm Perrigo had applied in the U.S. for a switch from prescription-only to over-the-counter (OTC) status for its once-daily oral contraceptive named Opill. The FDA could reach a final decision on switching the drug to OTC status as early as this summer.

Hormone-based oral contraceptives are the most common form of birth control in the U.S. There are multiple pills on the market, encompassing four generations of progestin-based products. Combined oral contraceptives contain two hormones, an estrogen, such as ethinylestradiol, and a progestin. Progesterone is the naturally occurring hormone in the body, while progestin is a synthetic hormone that mimics progesterone. The first generation progestin includes norethindrone and norethisterone; the second generation, levonorgestrel and norgestrel; the third generation, desogestrel, gestodene, and norgestodene; and the fourth generation progestin, drospirenone and dienogest. All four generations of products currently require a prescription in the U.S.

Opill contains progestin, which prevents pregnancy by blocking sperm from the cervix. Specifically, the mucus in the cervix thickens, making it difficult for sperm to enter the uterus and fertilize an egg. Opill was first approved as an oral contraceptive 50 years ago.

During the two days of deliberations the FDA advisory panel assessed whether the pill can they be used safely, effectively and easily by the appropriate consumers without a learned intermediary.

The unanimous vote by the advisory committee suggests Opill passed the test with flying colors and a formal OTC switch is imminent. Indeed, while the FDA doesn’t have to follow the advice of the advisory panel, it usually does.

However, it’s not quite a done deal. A remotely possible stumbling block concerns whether women who take the pill have difficulty understanding instructions on the label. Possible contra-indications, for example, need to be fully understood. This is where label comprehension studies come into play. Perrigo has conducted several such studies. These will be examined closely by the FDA prior to its final decision, in addition to reviewing the positive recommendations from the advisory panel. In this context, the FDA must answer in the affirmative that the drug is safe and effective for use “without supervision of a licensed healthcare practitioner or under the supervision of a pharmacist.”

For decades, the process of prescription to OTC switches has invariably relied heavily on evidence from safety and effectiveness studies concerning the prescription-only product. But, importantly, consumer studies, including actual use and label comprehension studies have traditionally been prerequisites to evaluate the “OTC-ness” of switch candidates. Here, the pertinent clinical questions include whether the product is safe and effective for consumers under conditions of actual use, whether there is a need for physician evaluation or monitoring, and the nature and severity of potential adverse effects associated with the product.

Clearly, the external panel of experts believes Opill checks the right boxes. Now the FDA itself will have to decide for itself.

In the U.S., there have been precious few switches lately in new OTC therapeutic classes. In this regard, Opill’s switch would represent a major move, at least for the U.S. Outside the U.S., oral contraceptives are OTC in approximately 100 countries.

In 2021, Opill won approval from the U.K.’s Medicines and Healthcare products Regulatory Agency to become the first OTC birth control pill in Britain. But, in most European nations, oral contraceptives remain prescription-only. At the same time, the majority of European nations guarantee that all women can obtain prescription oral contraceptives free of charge.

Likewise, in the U.S., the Affordable Care Act guarantees coverage of women’s preventive services, including free birth control. Most insurers must cover most methods of birth control at no cost, including prescription oral contraceptives.

It’s uncertain, however, whether insurers will cover OTC versions of the pill, such as Opill. Generally, OTC products are not covered by health insurance. And so access may still be a problem even when the product is OTC.

So, as the FDA moves one step closer to switching the status of Opill from prescription-only to OTC, it’s essential to understand that access is a multi-dimensional concept. Getting approved OTC is one aspect that certainly facilitates access, as there’s no need to get a prescription. But affordability is another part of the access equation. For low-income folks having an affordable OTC oral contraceptive will be crucial.