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FDA appears skeptical about over-the-counter birth control pill

In briefing documents, FDA scientists expressed concerns about whether the company, HRA Pharma, had provided sufficient data about the pill, which is already approved for prescription use.

Food and Drug Administration scientists on Friday expressed skepticism about whether the birth control pill can be switched from prescription to over-the-counter.

The assessment by FDA staff, included in briefing documents published Friday, comes ahead of a two-day meeting scheduled for next week, when the agency’s advisers will vote on whether to recommend that the agency allow a birth control pill called Opill to be sold over-the-counter.

If the advisers recommend it and the FDA goes on to approve Opill for over-the-counter use, it would be the first time the pill could be sold without a prescription. HRA Pharma, which makes Opill, expects the agency could make a final decision by the end of the summer.

Whether women can follow the package's instruction label and take the medication correctly seemed a chief concern of the FDA scientists, who doubted whether the pill maker had provided sufficient data.

Birth control pills must be taken at the same time every day. Failure to do so could lead to an unintended pregnancy, agency scientists wrote. But missing doses is not uncommon: Studies have shown that about half of women report missing a dose at least once a month.

The FDA approved Opill for prescription use in 1973. As part of the company’s application for over-the-counter use, the agency requested additional information about the drug’s effectiveness in today’s population. 

The updated analysis provided by the company, however, fell short, FDA scientists said, noting that it was based on low quality studies, many of which dated to the 1960s and '70s. 

FDA staff also questioned the findings from another study, called Access, in which researchers assessed whether participants took the drug according to the label’s instructions. The study found that about 97% of the time participants reported taking the drug correctly or following the label’s instructions if a dose was missed.

The agency, however, said it found that “a substantial portion” of participants overreported the number of pills they took or reported taking more pills than were dispensed — factors that “call into question the reliability of all of the actual use data.”

A push for more access to birth control 

In a statement released in response to the FDA’s briefing documents, a spokesperson for Perrigo, which owns HRA Pharma, maintained that Opill is safe and effective for over-the-counter use.

“Daily birth control was approved more than 60 years ago and progestin-only pills have a long track record as a safe and effective method to prevent pregnancy,” the spokesperson said. “We look forward to presenting our data and having a meaningful discussion on these topics on May 9 and May 10.”

Dr. Melissa Simon, a professor of clinical gynecology at Northwestern University, said she had not yet reviewed the FDA's conclusions Friday, but stressed that birth control pills like Opill are very safe.

"The chance of harm happening from taking one pill every day from an over-the-counter access standpoint, it's very low harm," she said. "You can harm yourself with other over-the-counter medications in the aisles of a pharmacy or local drug store much more than you can with these Opills."

She noted that birth control pills are already available over the counter in more than 100 countries.

The push for easier access to birth control comes amid a changing political landscape for women’s reproductive rights.

Last June, the Supreme Court overturned the landmark Roe v. Wade ruling that guaranteed a constitutional right to abortion. The Supreme Court in April rejected a lower court’s decision to issue a nationwide injunction on the drug mifepristone, one of two medications used in medication abortions. That case is still working its way through the lower courts, with the 5th Circuit scheduled to hear oral arguments on May 17.

HRA Pharma is asking the FDA to approve the over-the-counter birth control pill for all women of reproductive age. 

Making the pill available without an age restriction could be especially important for younger teens and adults who often have a lot of barriers to accessing health care and getting birth control prescriptions, said Dr. Kristyn Brandi, a member of the American College of Obstetricians and Gynecologists. Among 15 to 17 year olds in the United States, 72% of pregnancies were unintended, according to data provided by the FDA. 

Other contraceptives, like condoms, involve the active participation of the women’s partner. 

Brandi declined to comment on the FDA's conclusions in the briefing documents. 

In Friday’s documents, the FDA noted that in a prescription setting, progestin-only medications have been demonstrated to be safe. The agency noted that there is a risk of breast cancer and undiagnosed vaginal bleeding, and said it planned to ask the advisory committees next week whether they think consumers will be able to evaluate those safety risks for themselves. (These risks are common among hormonal birth control medications.)

Agency staff also noted that there was a lack of information on use in adolescents and whether they could follow the label’s instructions.  

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