The birth control pill first came on the market in 1960. It uses female hormones to control fertility … [+]
Today, at a meeting of a Food and Drug Administration (FDA) advisory committee, a panel of independent experts voted unanimously 17 to 0 that the FDA should approve the first over-the-counter birth control pill.
Irish firm Perrigo had filed in the US for a switch from prescription-only to over-the-counter (OTC) status for their once-daily oral contraceptive called Opill. The FDA could make 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 US. There are several pills on the market, including 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 US
Opil 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 consultation the FDA advisory panel assessed whether the pill can be used safely, effectively, and easily by the right consumers without a learned middleman.
The unanimous vote by the advisory committee suggests that Opill passed the test with flying colors and that a formal OTC switch is imminent. While the FDA is not required to follow the Advisory Panel’s advice, it usually does.
However, it’s not quite a done deal yet. A remotely possible stumbling block is whether women taking the pill have trouble understanding the instructions on the label. For example, potential contraindications should be fully understood. This is where label understanding research comes into play. Perrigo has conducted several such studies. These will be scrutinized by the FDA prior to the final decision, in addition to reviewing the Advisory Panel’s positive recommendations. In this context, the FDA must answer in the affirmative that the drug is safe and effective for use “without the supervision of a licensed physician or under the supervision of a pharmacist.”
The process from prescription to OTC is decades long switches has invariably relied heavily on evidence from safety and effectiveness studies related to the prescription product. But more importantly, consumer studies, including actual usage and label understanding research, have historically been a requirement to evaluate the “OTC-ness” of switching candidates. Here, the relevant clinical questions include whether the product is safe and effective for consumers under actual conditions of use, whether there is a need for evaluation or monitoring by a physician, and the nature and severity of any potential adverse effects associated with the product.
Clearly, the outside panel of experts believes Opill ticks all the right boxes. Now the FDA will have to decide for itself.
In the US, there have been few changes in new OTC therapeutic classes recently. In this respect, Opill’s move would be a big step, at least for the US. Outside the US, oral contraceptives are available over the counter in about 100 countries.
In 2021, Opill received approval from the UK’s Medicines and Healthcare products Regulatory Agency to become Britain’s first OTC contraceptive pill. But in most European countries, oral contraceptives remain prescription-only. At the same time, most European countries guarantee that all women can obtain free prescription oral contraceptives.
Similarly, the Affordable Care Act in the US guarantees coverage of preventive services for women, including free contraception. Most insurers should cover most methods of birth control for free, including prescription oral contraceptives.
However, it’s uncertain whether insurers will cover OTC versions of the pill, such as Opill. In general, OTC products are not covered by health insurance. And so access can still be a problem even if the product is OTC.
So as the FDA moves one step closer to changing Opill’s status from prescription-only to OTC, it’s essential to understand that access is a multidimensional concept. Getting approved OTC is one aspect that certainly eases access as no prescription is required. But affordability is another part of the access equation. For low-income people, having an affordable over-the-counter oral contraceptive is crucial.