FDA Raises Concerns Regarding Perrigo's OTC Birth Control Pill, Casts Doubts Over Real-World Use

The FDA's Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) will be meeting this week to review Perrigo Company plc's PRGO Opill daily oral contraceptive for over-the-counter (OTC) use.

The FDA released briefing documents ahead of this week's joint expert panel meeting to discuss two questions:

How likely are consumers to use the product effectively and safely, using only the nonprescription labeling and without assistance from a healthcare professional?

Whether consumers who should not use the product will not use it (i.e., whether consumers will appropriately self- "deselect") 

Contraceptives available without a prescription include condoms and spermicides. Several prescription contraceptives exist, too. However, the FDA said that the availability of a nonprescription daily oral option like Opill would "reduce barriers" that women face in obtaining effective means of birth control.

The FDA added that the safety and effectiveness of such pills would be contingent on how consumers can appropriately use them.

Opill carries "important risks," particularly in those with a history or risk of breast cancer or other progestin-sensitive cancers, vaginal bleeding of undiagnosed etiology. Opill can also interact with other medications, the FDA said. Thus making it vital for consumers to decide when not to use the drug appropriately.

Price Action: PRGO shares are up 0.31% at $35.85 on the last check Monday.