FDA approves first over-the-counter birth control, made by Grand Rapids firm
- The FDA approved the first over-the-counter oral contraceptive pill
- Opill will become available for purchase online and at retail stores in the first quarter of 2024
- Women no longer need a doctor’s prescription for birth control
The U.S. Food and Drug Administration approved the first ever over-the-counter birth control pill on Thursday.
The new drug Opill, is an oral-contraceptive pill that can be purchased without a prescription. Perrigo, a North American pharmaceutical company with headquarters in Grand Rapids, created the drug, which has been prescribed to patients since 1973 and marketed by Pfizer as Ovrette for more than 30 years.
"Today marks a truly momentous day for women's health nationwide," said Patrick Lockwood-Taylor, president and chief executive officer of the company. "Opill has the potential to radically transform women's access to contraception and is a true testament of Perrigo's unwavering commitment to deliver impactful solutions that truly make lives better."
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The drug will become available online and in retail stores across the country in the first quarter of 2024, the company said in a news release. The cost of the medication has not been announced yet.
The company said that the medication is supported by the American College of Obstetricians and Gynecologists, the American Medical Association, the Society for Adolescent Health and Medicine and the American Academy of Family Physicians.
In May, members of the FDA's Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee voted 17 to 0 to approve the pill, noting that the benefits outweigh the risks.
"Perrigo is committed to making Opill, which is now the most effective method available (over the counter) at preventing pregnancy and affordable to women and people of all ages,” Frederique Welgryn, global vice president for women's health, said in the news release.
“I want to thank the FDA and its advisory panels, the Free The Pill coalition, the numerous medical organizations and advocacy groups, and all those who wholeheartedly supported this enormous undertaking that has made today a giant leap for women's empowerment.”
Critics argue that providing the pill over-the-counter may encourage some women to take the pill without seeing a doctor, particularly those with conditions such as breast cancer and certain underlying conditions who aren’t supposed to use it.
Currently, women seeking birth control have to go to a doctor’s office, health clinic or a local planned parenthood and get a prescription. Most insurance companies cover birth control pills and other contraceptives, but it may only be for specific or generic brands.
According to the Centers for Disease Control and Prevention, nearly 65 percent of women between 15 and 49 used contraception between 2015 and 2017.
“Removing the prescription requirement for Opill improves access to a contraceptive method that is effective and well tolerated for all ages of women and people who can get pregnant,” the company said in the news release.
Perrigo’s North American headquarters was in Allegan before they opened a new office in the “Medical Mile” area of downtown Grand Rapids in 2022.
In that same year the company bought HRA Pharma, acquiring the British company’s then just-approved over the counter birth control pill. The $2.6 billion deal launched Perrigo’s attempt to get U.S. approval for the medication from the FDA.
The company has both United States and international divisions, with 80 global facilities — including 43 in the United States. In Michigan, they include an oral care division in Grand Rapids that produces items like tooth-whitener, a distribution warehouse in Holland, and an outlet store in Allegan.
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