OTC birth control could be on the way from Perrigo, as FDA gathers expert panel

Americans might soon get their hands on a birth control pill, no prescription needed.

A joint FDA advisory committee meeting is scheduled for November 18 to review Perrigo’s application for Opill, a daily oral contraceptive, for over-the-counter use. If approved, the drug would be the first birth control available without a prescription in the U.S.  

The nonprescription drugs advisory committee and the obstetrics, reproductive, and urologic drugs advisory committee will review Perrigo affiliate HRA Pharma’s application for an Rx-to-OTC switch of the progestin birth control pill, a non-estrogen option. The application was submitted in July, shortly after the Supreme Court decided to overturn Roe v. Wade, instigating a nationwide debate on reproductive rights.

The company beat out fellow birth control maker Candence Health, which has also been in discussions with the FDA about converting the meds approval into an over-the-counter one.

Opill was approved in 1973. Despite the many contraceptive options out there, nearly a third of adult U.S. women still found it difficult to obtain or refill a prescription, according to HRA.

“Removing the prescription requirement with Opill would improve access to a contraceptive method that is well tolerated and notably more effective at preventing pregnancy than all currently methods available OTC,” the company has said.

Perrigo shelled out $2.1 billion for HRA last September, picking up its leading consumer medicines in blister care, scar care, and women’s health. The acquisition was “the crowning achievement” in Perrigo’s multi-year transformation into a “focused and high-preforming consumer self-care company,” said CEO Murray Kessler in a company statement at the time.

Meanwhile, last month Perrigo was dismissed from a key Zantac case, in which plaintiff George Bayer sued 13 companies, alleging that taking Zantac caused his esophageal cancer. Perrigo, Teva, Dr. Reddy’s and Sun Pharma agreed to a combined settlement of $500,000.