FDA Schedules Meeting To Potentially Approve OTC Birth Control Pill

A potentially ground-breaking decision could greatly impact a woman’s access to contraceptives.

We don’t think twice about pain relievers, allergy medications, antihistamines, and acid reducers that made the switch from prescription-only to over-the-counter sale. But a new proposal to make birth control pills available as an OTC is gaining ground.

For the first time, a pharmaceutical company is asking for permission to sell a birth control pill over the counter in the U.S.

The Food and Drug Administration (FDA) scheduled a joint review of the product to convene in November. It’s purpose is to consider making a progestin-only daily pill available for sale without a doctor’s order. The pharmaceutical company HRA Pharma filed an application in July, requesting what is known as a “switch” from prescription to OTC.

Because it only has one hormone, and is not a combined pill (which has both estrogen and progesterone) this is referred to as a mini pill and is considered low risk.

In order to “make the switch,” companies have to demonstrate to the FDA that consumers can understand the drug’s labeling, evaluate its risks, and use it safely and effectively without medical supervision.

HRA Pharma spent seven years conducting the FDA-required studies, including a trial that followed 1,000 women taking the OTC pill for six months.

Progestin-only birth control pills have fewer potential risks for women with specific health risks like heart conditions. Birth control containing estrogen is associated with risk of blood clots. Overall, ‘the pill’ — no matter the hormone configuration — does not see much misuse and abuse: they are not addictive, and do not cause severe toxicity if overdosed. In other words, there’s a high likelihood that this petition will pass inspection.

Interestingly, the U.S. is one of the few countries in the world that requires women to have a prescription to obtain birth control pills. At least 122 other countries already have some form of oral birth control pill available as OTC (oral is by far the most popular version of the pill in America).

Advocates for women’s health say requiring a doctor’s visit actually serves as a significant barrier to reproductive health, especially for those who lack access to a healthcare provider.

The American Medical Association (AMA) is supporting the proposal, which would only cover this particular birth control pill. They have publicly stated that science and data have for years shown that birth control is safe without a doctor’s prescription.

So what does this mean for you?

A lot of things remain to be resolved, for instance whether an OTC pill would be covered by insurance or not. If it is given a green light by the FDA, this pill could be sold at community-based drug stores sometime in the new year.

Oh, in case you’re wondering- the daily birth control pill is called Opill.