U.S. FDA advisers back OTC use of Perrigo's birth control pill (updated)

Perrigo

10/05/2023 18:40

(Recasts lede, adds background on contraceptives in paragraph
2, adds details from meeting throughout)
       May 10 (Reuters) - A U.S. Food and Drug Administration
advisory panel on Wednesday voted in favor of using Perrigo Co's
 PRGO.N  contraceptive without a prescription, paving the way
for the country's first approval for an over-the-counter birth
control pill. 
    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.
    The panel remained positive on the effectiveness of the
pill, not only in the general population of women but also in
adolescent populations and those with limited literacy.
        The advisers' decision comes after the FDA reviewers on
Friday raised concerns around allowing daily over-the counter
use of Opill, saying switching to non-prescription sale could
lead to inappropriate usage by consumers.
        Perrigo's Opill, currently approved for prescription
use, would be the first OTC non-estrogen contraceptive pill in
the United States if approved by the regulator.
    The FDA generally follows the advise of its experts, though
it is not bound to do so. 

 (Reporting by Sriparna Roy and Nandhini Srinivasan in
Bengaluru; Editing by Shailesh Kuber)
 ((Sriparna.Roy@thomsonreuters.com;))