— “Benefits are big, and the drug is extremely reliable,” states advisory committee chair
by Rachael Robertson, Enterprise & & Investigative Writer, MedPage Today
May 10, 2023
In a consentaneous vote, consultants to the FDA suggested the company authorize what might end up being the first-ever over-the-counter (OTC) contraceptive pill.
All 17 members of the joint Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee stated the extensive advantages of changing day-to-day norgestrel tablets 0.075 mg (Opill) to nonprescription status surpass issues raised by the FDA.
“The advantages are big, and the drug is extremely reliable,” stated panel chair Maria Coyle, PharmD, of the Ohio State University in Columbus.
Panelists mainly got rid of some doubts about the proposed labeling and whether customers would comprehend how to utilize the item properly.
“I believe it will work in the over the counter world,” Coyle stated, “especially considered that there might be very little education happening presently even for prescription users of a few of these medications.”
Kathryn Curtis, PhD, of the CDC in Atlanta, stated the big body of proof on the efficiency and security given that the prescription kind was authorized a half-century earlier is “really comforting.”
She mentioned that all of the quotes on failure rates with norgestrel (2-4 per 100 person-years) provided throughout the 2-day conference were lower than other OTC contraception items (e.g., prophylactics, spermicides), and lower than other contraceptive pills in the prescription setting.
And she included that “these pil