US FDA staff raises concerns over OTC use of Perrigo’s birth control pill

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U.S. health watchdog reviewers on Friday raised concerns about allowing Perrigo Co.’s birth control drug over-the-counter, saying a shift to over-the-counter sale could lead to inappropriate use by consumers.

Perrigo’s Opill, which is currently approved for prescription use, would be the first non-estrogen-containing contraceptive pill in the United States if approved.

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Contraceptives have been a focus since last year the US Supreme Court struck down the constitutional right to terminate pregnancy as it overturned a landmark ruling in Roe v. Wade in 1973.

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The review, conducted by FDA staff on Friday, comes before an advisory meeting next week, where panel members will decide to recommend Opill as an over-the-counter daily pill.

While the FDA noted that the availability of over-the-counter daily oral contraceptives may reduce barriers women face in obtaining effective methods of contraception, the reviewers added that the safety and effectiveness of these pills will depend on how consumers use them appropriately.

The FDA said in its information documents that it is critical that consumers decide appropriately when not to use the drug because it has risks that differ from those associated with currently available over-the-counter birth control methods.

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The reviewers cited risks of breast cancer or other progestin-sensitive cancers and vaginal bleeding without any known causes, among other things.

They also expressed concerns about the pill’s potential diminished efficacy in individuals who are overweight or obese — a group that accounts for about 60% of the total population of childbearing age in the United States.

The Food and Drug Administration even highlighted that one of the company’s studies was not adequately designed to assess whether delaying taking the pill could affect its effectiveness in preventing pregnancy.

Shares of the company fell nearly 2% after the briefing documents were released.

(Reporting by Leroy Liu in Bengaluru; Editing by Shonak Dasgupta and Chingini Ganguly)