FDA raises issues with nonprescription birth control pill

Perrigo’s shares fell after U.S. regulators raised concerns about whether its birth-control product Opill would be suitable as an over-the-counter drug.

Opill may not be effective as a nonprescription pill given Americans’ increasing body weight, regulators said in briefing documents. Staff also cited major limitations in crucial data submitted by the company in support of an over-the-counter switch.

The U.S. Food and Drug Administration posted the documents Friday in preparation for a meeting next week when agency advisers will vote on whether to recommend Opill’s over-the-counter sale, which has the potential to make it much more widely accessible.

While Opill has been available in the U.S. with a prescription since 1973, reproductive rights advocates have long argued that oral contraception should be available over the counter, as is the case in more than 100 countries. HRA Pharma, Perrigo’s unit that makes the drug, sought FDA approval for an over-the-counter version last summer after the Supreme Court overturned the landmark Roe v. Wade ruling, curbing access to abortion in some parts of the country.

Shares of Perrigo fell as much as 5.3% in New York before paring their decline.

The company said Friday that data compiled over eight years show that consumers can use Opill safely and effectively as guided by the proposed label.

“There is a significant need for improved access to effective contraception, now more than ever,” Perrigo said in an emailed statement.

The original approval of Opill in the 1970s was based on data that reflected the population likely to use the product at that time. Since then, factors such as rising levels of obesity could impact the efficacy of the drug for today’s reproductive-aged population, the FDA report said. The company failed to provide additional insight into how the drug’s efficacy could be impacted by this without a doctor’s clearance, according to the agency’s findings.

People who are overweight or obese represent about 60% of the U.S. reproductive-aged population, the FDA said in the report, citing the latest data from the National Institute of Diabetes and Digestive and Kidney Diseases.

The FDA had set an advisory panel meeting to review the application in mid-November, but that meeting was postponed until May because the agency wanted more information from the company.

The FDA asked questions about the company’s study on whether participants would be able to follow the instructions for taking one pill a day, Frédérique Welgryn, HRA Pharma’s global vice president for women’s health, said Monday on a call with reporters.

The study asked 883 participants to complete a diary recording their daily use. The FDA noted that the results showed 261 subjects reporting that they took Opill on more days than they had received supplies for. An outside analysis commissioned by HRA Pharma found that factors such as data entry mistakes and participant incentive might have contributed to over-reporting.

This issue is a “major limitation” of measuring medication adherence and whether participants used Opill correctly, FDA staff said in the report. Correct use of the pill is critical to assessing whether Opill could be used effectively as an over-the-counter product.

The FDA’s Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee will meet jointly on Tuesday and Wednesday to discuss these discrepancies. Both the company and the FDA will present their findings.

While oral birth control has long been considered safe, regulators have required a prescription for these drugs so that doctors can screen patients with medical conditions that may be aggravated by the hormones in the medication. For example, combination birth control pills, which contain the hormones estrogen and progestin, are associated with side effects such as serious blood clotting in people with a history of clots or high blood pressure.

Opill contains only progestin and doesn’t raise clotting risk, according to research. However, drugs like Opill aren’t recommended for people with certain conditions like breast cancer or liver disease.