FDA Approval of US First OTC Contraceptive

Access to reproductive healthcare options has recently expanded in the United States due to the FDA’s recent approval of the country’s first over-the-counter (OTC) contraceptive.

With this approval, FWGBD turned to reproductive health advocate and family planning expert, Dr. Maureen Baldwin, to learn more about this new option.

Q. Is this a safe option?
“Over-the-counter availability of oral progestin is very safe – the packaging has passed through rigorous testing to determine that users can screen themselves and understand how to use it. This pill is currently only FDA-approved for contraception, so the instructions are focused on that indication. In my opinion, based on pharmacology this pill can be used just as we use other oral progestins for the management of heavy menstrual bleeding. It should only be administered in a continuous daily regimen.”

Q. How does this impact people with blood/bleeding disorders?
“We don’t know how this might impact people with heavy menstrual bleeding. For heavy menstrual bleeding, 0.075 mg norgestrel [Opill] is most likely to have similar outcomes to the 0.35 mg norethindrone, including some unscheduled breakthrough bleeding. We will have to see. Most importantly, this adds a patient-centered option for access to menstrual therapies.”

Q. What should practitioners take into consideration for patients wanting to explore this as a contraceptive?
“The manufacturers have not yet set the shelf price for this over-the-counter medication. It is possible that the out-of-pocket cost will be higher than the cost of other prescription contraceptives for people with insurance coverage. Providers could consider writing a prescription for Opill, though it may not be on formularies for some time. The great news is that this option removes unnecessary barriers to a safe and effective contraceptive.”

Dr. Baldwin also suggests for those looking to learn more about the Opill, to read the FAQs available on the FDA website: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/opill-0075mg-oral-norgestrel-tablet-information

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