FDA, weighing Perrigo's OTC birth control application, raises questions about real-world use

As a long-awaited advisory committee meeting on Perrigo’s over-the-counter birth control prospect Opill nears, the FDA says many big questions remain. Chief among them: Will people use the drug as intended in the real world?

Ahead of this week’s joint expert panel meeting, the FDA released briefing documents posing two main questions for its expert committees: First, just how likely are consumers to use Opill “in an effective and safe manner,” relying solely on the nonprescription prospect’s label and without help from a healthcare professional?

Second, will consumers who shouldn’t use the product avoid the temptation? 

Perrigo and the FDA's independent advisers are set for the joint advisory committee meeting on Tuesday and Wednesday. The meeting had originally been scheduled for Nov. 18, 2022, but the FDA delayed the process in October, hamstringing Perrigo’s hopes of an OTC approval in the first half of 2023.

Perrigo picked up Opill last May when it bought HRA Pharma for $1.9 billion. Opill in its prescription format was first approved back in 1973.

As it stands, contraceptives available without a prescription include condoms and spermicides. A suite of prescription contraceptives exists, too, though the advent of a nonprescription daily oral option like Opill would “reduce barriers” that women face obtaining effective means of birth control, the FDA said.

Still, the FDA reiterated that the safety and effectiveness of the med in a nonprescription setting is “contingent on whether a consumer can appropriately self-deselect and adhere closely to the directions for use, or correctly choose not to use the product.”

Opill carries “important risks,” particularly in those with a history or risk of breast cancer or other progestin-sensitive cancers. Opill can also interact with other medications, the FDA said.

The regulatory race for over-the-counter Opill has garnered much attention in the wake of the U.S. Supreme Court’s decision last June to overturn the Roe v. Wade case that legalized abortion nationwide. In support of its OTC approval, Perrigo has furnished the FDA with a label comprehension study designed to assess patient’s understanding of the OTC product’s label and breast cancer patients’ tendency to self-deselect from using the drug.

Perrigo also handed over results from a label comprehension study on its consumer information leaflet, which would accompany the drug facts label in Opill’s over the counter packaging.

Ultimately, the FDA wants its advisers to weigh in on six main points.

The regulator’s concerns come down to the “adequacy of evidence” around correct use and adherence without directions from a doctor.

Further, the FDA is concerned about patient comprehension around women with current or historic breast cancer choosing not to take the drug. The same goes for women with abnormal vaginal bleeding that could suggest a hormonally sensitive condition like uterine cancer.

Plus, it’s concerned about how easily adolescents and people with “limited literacy” will be able to understand how to administer the product.

If eventually approved, non-estrogen Opill would become the first daily contraception drug available without the need for a prescription in the U.S.