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WASHINGTON – The Consumer Healthcare Products Association (CHPA) today released the below statement following a U.S. Food and Drug Administration (FDA) joint advisory committee meeting, which concluded that Opill, a once-daily oral contraceptive, should be approved as the first oral contraceptive for use without a prescription:
“Today’s recommendation is a win-win for both consumers and the entire U.S. healthcare system,” said CHPA Senior Vice President of Legal, Government Affairs & Policy, David Spangler. “Access is about removing barriers, and when it comes to oral contraceptive pills – already among the most common contraceptive methods used by women – OTC availability will, simply put, increase access.”
“Availability of OTC medicines provides significant public health benefits,” continued Spangler, “by empowering consumers to take greater control over their own health, while at the same time, helping to save our healthcare system billions of dollars annually. CHPA applauds today’s unanimous vote, which overwhelmingly upholds the decades of evidence and support presented this week in regards to the tremendous public health benefits driven by better access to oral contraceptives. We look forward to FDA accepting this recommendation and hope to see even more switch applications submitted to FDA in the future.”
Background:
In the United States, the leading cause of unintended pregnancy is inconsistent or lack of contraceptive use. In fact, among the 40 million U.S. women at risk of experiencing an unexpected pregnancy each year, one-third are either not using a contraceptive method or are using a method classified by the U.S. Centers for Disease Control and Prevention (CDC) as less effective. Additionally, a 2015 study found more than one-fifth of low-income women at-risk for unintended pregnancy were very likely to use oral contraceptive pills if available over-the-counter (OTC).
OTC access to beneficial consumer healthcare products, including oral contraceptives, facilitates a broader, more constant supply by removing steps and increasing availability of access points.
Following today’s meeting, FDA will now consider the advisory panel’s favorable recommendation. Should FDA accept the recommendation, it will mark the first time a daily oral contraceptive is approved for use without prescription.
Click here to listen to Spangler’s full remarks from Tuesday’s Open Public Hearing portion of FDA’s advisory committee meeting.
