I remember working part-time as a pharmacist when I was at FDA and there were only a few prescription oral contraceptives that were available for dispensing at that time. If you had asked then (1984) if I thought that there would ever be an OTC version of an oral contraceptive available, I would have bet the farm that there would be no way the FDA would allow OTC marketing of this product. Well, here we are just a short 39 years later, and I am glad I did not make that bet!
“Today the FDA approved Opill (norgestrel) tablets for nonprescription use to prevent pregnancy and is the first daily oral contraceptive approved for use in the US without a prescription”. “The FDA granted the approval to Laboratoire HRA Pharma, recently acquired by Perrigo Company plc.” The date of availability and price of Opill in the US marketplace will be determined by the manufacturer.
The FDA announcement (here) notes that the safety and efficacy of norgestrel was established by the original NDA approval in 1973 and HRA Pharma applied for an Rx to OTC switch. To support the OTC use, the firm had to establish “that the product can be used by consumers safely and effectively relying only on the labeling of the product without any assistance from a health care professional.” As such, there were label comprehension studies that showed that the product could be used safely and that patients were able to properly select or deselect themselves as appropriate users of the product.
The notice further discusses the proper use of the product and notes that the Opill is not for emergency contraception and does not prevent pregnancy after unprotected sex and does not prevent transmission of venereal disease.
This should make oral contraception more readily available to patients who choose to use it without having to see a healthcare provider.
