A panel of FDA advisors voted The consensus on Wednesday said the benefits of making the pill available without a prescription outweigh the risks, an important step in the decades-old campaign to make oral contraceptives obtainable without a prescription in the United States.
If the U.S. Food and Drug Administration (FDA) approves over-the-counter sale of the drug, called Opill, this summer, it could greatly expand access to contraceptives, especially for young women and those who struggle with time, costs, or Logistical hurdles involved in visiting a doctor or reproductive health expert say.
Consent is not a foregone conclusion, however. FDA scientists analyzing data provided by the pill’s manufacturer, HRA Pharma, raised concerns about whether women with medical conditions that prevent them from taking the pill — particularly breast cancer and undiagnosed vaginal bleeding — would avoid the product.
The agency’s reviewers also questioned the reliability of data from the company’s study that was meant to show that consumers would follow label directions to take their birth control pills at around the same time each day and use another form of birth control or abstain from sex if that happened. to miss a dose. FDA analysts have also raised questions about whether younger teens and people with limited literacy could follow the directions.
“The FDA has been placed in a very difficult position of trying to determine whether this product is likely to be used safely and effectively by women in a non-prescription setting,” said Dr. Karen Morey, deputy director of the FDA’s Office of Non-Prescription Drugs. During the advisory committee panel discussion on Wednesday afternoon.
“We can’t approve it solely based on experience with prescribing without the applicant having done enough studies to consider what might happen in a non-prescribing environment,” she said. “But I wanted to stress again that the FDA understands how important women’s health is and how important it is to try to increase access to effective birth control for American women.”
Advisory panel members overwhelmingly said those concerns were largely overshadowed by a public health need and the long history of safety and effectiveness of Opill, which has been approved for prescription use 50 years ago.
“The panel is confident in the efficacy, not only in the general female population, but also in adolescents and those with limited literacy,” said panel chair Maria Coyle, a pharmacist and assistant clinical professor in Ohio. State University. “The committee appears very comfortable with the limited number of risks posed by the drug itself.”
Advisory committee members included a wide range of medical professionals: obstetricians and gynecologists, adolescent medicine specialists, breast cancer specialists, and experts in consumer health behavior and health education.
The FDA had originally scheduled the committee’s public hearing for last November, but pushed it back until this spring after asking the company to provide additional information.
Since the Supreme Court struck down the national right to abortion nearly a year ago, access to contraception has become even more urgent. The move to provide over-the-counter pills for all ages has been greatly supported by reproductive and adolescent health professionals and groups such as American Medical Associationthe American College of Obstetricians and Gynecologists And American Academy of Family Physicians.
in Survey by the healthcare research organization KFFMore than three-quarters of women of childbearing age prefer over-the-counter birth control pills, mainly because of the convenience.
While some Catholic organizations have spoken out against over-the-counter contraceptives, most anti-abortion groups have been silent on the issue. Support was expressed in the vast majority of hundreds of comments made before the hearing, which began on Tuesday, and by most of the 37 people who spoke during the public comment portion of the hearing.
Opill is known as a “mini-pill” because it contains only one hormone, progestin, unlike “combined” pills, which contain both progestin and estrogen. The company that makes the combination birth control pill, Cadence Health, has also entered discussions with the Food and Drug Administration about applying for an over-the-counter status.
Dr. Daniel Grossman, professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, spoke in support of the over-the-counter effort at the Advisory Committee hearing Tuesday. He said in an interview that both types of pills are safe and 93 percent effective in preventing pregnancy with regular use.
He said combination pills were more popular in the United States, but that may be because progestin-only pills, which are widely used in Europe, have not been marketed as much in that country.
HRA Pharma, which was bought last year by Perrigo, a Dublin-based maker of over-the-counter medicines, already sells progestin-only over-the-counter pills in the UK.