U.S. FDA advisers back Perrigo birth control pill for over-the-counter use
12:19 am Thursday, May 11th, 2023
By Sriparna Roy and Nandhini Srinivasan
(Reuters) -A U.S. Food and Drug Administration advisory panel on Wednesday voted in favor of allowing sales of Perrigo Co’s contraceptive drug without a prescription, paving the way for the country’s first over-the-counter birth control pill.
The panel found the drug to be an effective OTC option with some members noting that it could expand the availability of birth-control alternatives to more people.
“The benefit of Opill being available to diverse populations including adolescents and those with limited literacy is in demand,” said Dr Jolie Haun, a panelist who voted in favor of the pill.
On Friday, the FDA had raised concerns around the drug’s studies, including whether participants were able to follow dosing instructions.
Panel members said that more women were likely to be harmed by an unplanned or unwanted pregnancy than the side effects of the drug. The FDA generally follows the recommendations of the advisory panel.
Contraceptives have been in focus since the U.S. Supreme Court last year overturned the constitutional right to terminate pregnancies as it scrapped a landmark ruling in the 1973 Roe vs. Wade case.
“As a physician, birth control pills are one of the safest medications I can prescribe to my patients,” said Dr Daniel Grossman, a steering committee member at advocacy group Free the Pill.
“Removing the medically unnecessary prescription requirement will mean that more people can get care without barriers.”
Perrigo gained the daily-use pill first approved by the FDA in 1973 through its $2.13 billion acquisition of Paris-based HRA Pharma in 2021.
Shares in the company rose 4.6% on Wednesday.
(Reporting by Sriparna Roy and Nandhini Srinivasan in Bengaluru; Editing by Shailesh Kuber and Vinay Dwivedi)
