The Food and Drug Administration's advisory panels voted unanimously to recommend Perrigo's request to sell their daily birth control pill without a prescription.
The joint meeting, which spanned two days, included the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee.
Although the FDA is not obligated to follow the advisory committee's recommendations, it is anticipated that the vote will have significant weight on the FDA's final decision, which is expected later in the summer.
If the agency decides to approve the recommendation, Perrigo's Opill would be the first contraceptive pill to become available over-the-counter without a prescription.
FDA Advisory Panel Approves Perrigo's Opill
Perrigo's Opill, a progestin-only daily oral contraceptive, has been approved for use with a prescription since it was first approved by the FDA in 1973. The drug has been widely used and is considered safe and effective in preventing pregnancy. Now, the company is seeking approval to make the drug available over-the-counter, which would make it the first birth control pill available without a prescription in the United States.
According to Perrigo, the joint committee of the FDA's Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee voted unanimously in favor of making Opill available over-the-counter.
The committee members noted that the benefits of making the drug more widely available, especially to young people and lower-income groups, outweigh the risks. However, the vote is not binding, and the FDA will consider the panel's recommendation when making its final decision on whether to approve the medication for over-the-counter use.
During the committee meeting, FDA officials raised concerns about several flaws in the company's data, including whether women, especially those with low literacy skills, would be able to understand the drug's instruction label.
However, the panel members believed that most women could determine whether the medication was appropriate to use on their own and urged the FDA to approve the medication for over-the-counter use.
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Pressure on the Accessibility of Birth Control
Contraceptive pills are available without a prescription in regions such as Africa, South America, and Asia, according to the Associated Press.
The FDA's decision to approve Opill for over-the-counter use is a significant step towards improving access to contraception in the United States.
Despite concerns raised by FDA officials regarding the drug's label instructions and study data, the advisory panel concluded that the benefits of making Opill available without a prescription outweighed the risks.
Panel members noted that access to effective birth control is particularly important for lower-income individuals, Black women, and those who have not completed high school, as they are more likely to experience unintended pregnancies.
The decision is expected to be considered by the FDA when it makes its final decision on the potential approval of Opill for OTC use, which is anticipated later this year.
According to CNN, the approval of Opill for OTC use has been met with support from lawmakers and health care providers who have been advocating for increased access to contraception in the United States. Lawmakers have written to the FDA Commissioner, highlighting the importance of the issue for reproductive health, rights, and justice.
A recent study has shown that many women have experienced barriers to accessing reproductive health care services in recent years, including routine screenings and birth control.
The approval of Opill for OTC use could pave the way for other drugmakers to seek OTC sales of their birth control pills.
The availability of Opill and other birth control options over-the-counter could provide more options for individuals to take control of their reproductive health.
