FDA advisers say benefits of over-the-counter oral contraceptives outweigh risks

The Food and Drug Administration Advisory Board voted It was unanimous on Wednesday that the benefits of making oral contraceptives available without a prescription outweigh the risks, citing decades of efforts to make them available over-the-counter in the United States. This is an important step.

If the FDA approves a drug called opil for sale without a prescription this summer, it could be especially useful for young women and those who find it difficult to deal with the time, expense and logistical hurdles associated with doctor visits, reproductive health, and reproductive health. Access to contraception could be significantly expanded for young women. experts say.

However, approval is not a foregone conclusion. Analyzing data submitted by her HRA Pharma, the maker of the pill, her FDA scientists found that women with medical conditions that should prevent them from taking the pill (mainly vaginal bleeding that hasn’t been diagnosed with breast cancer) took the product. I expressed my concerns about whether to avoid it.

The agency’s reviewers said the results from the company’s research aimed to show that consumers took the pill at about the same time each day as directed on the label, used another method of contraception, or abstained from sex. I also questioned the reliability of the data. Miss the dose. FDA analysts also questioned whether adolescents and people with limited literacy would be able to follow the instructions.

“FDA is in a very difficult position trying to determine whether women are likely to use this product safely and effectively in the non-prescription setting,” said the FDA’s non-prescription drug. Dr. Karen Murry, Deputy Director of the Office of Medicines said. at an advisory board debate on Wednesday afternoon.

“We cannot grant approval based on experience in the prescription setting without the applicant conducting adequate research to see what might happen in the non-prescription setting,” she said. But I would like to reiterate that the FDA recognizes how important women’s health is and how important it is for women in the United States to have access to effective contraception.”

Advisory panel members overwhelmingly said that Opill’s long history of safety and efficacy, approved for prescription use 50 years ago, and public health needs far outweigh these concerns. increase.

“The committee has expressed confidence in its effectiveness not only for women in general, but also for adolescent groups and those with limited literacy,” said the committee chair. says Maria Coyle, a pharmacist and associate clinical professor at Ohio University. state university. “The committee seems very satisfied with the limited number of risks from the drug itself.”

Advisory board members included a wide range of medical professionals, including obstetricians and gynecologists, adolescent medicine specialists, breast cancer specialists, and consumer health behavior and health literacy specialists.

The FDA originally scheduled a committee hearing in November last year, but postponed it until this spring after asking the company to provide additional information.

Contraceptive accessibility has become more urgent since the Supreme Court overturned the nation’s right to abortion almost a year ago. The move to make prescription-free pills available to all age groups has prompted reproductive health and adolescent health experts, American Medical Association, American College of Obstetricians and Gynecologists and American College of Family Medicine.

and Research by health care research institute KFFMore than three-quarters of women of reproductive age preferred over-the-counter medications primarily for convenience.

Some Catholic organizations have spoken out against over-the-counter birth control, but most anti-abortion groups have remained silent on the issue. Most of the comments, and most of the 37 people who spoke during the public comment portion of the hearing, expressed their support.

Opil is known as a “mini-pill” because it contains only one hormone, progestin, as opposed to the “combination” pill, which contains both progestin and estrogen. Cadence Health, which makes combination pills, is also in talks with the FDA about applying for over-the-counter marketing.

Daniel Grossman, Ph.D., professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, spoke in support of over-the-counter efforts at an advisory board hearing on Tuesday. He said the type of pill is also safe and about 93% effective in preventing pregnancy with regular use.

Combination pills are more popular in the United States, which may be because progestin-only pills, which are widely used in Europe, are not well marketed in this country.

HRA Pharma, which was acquired by Dublin-based over-the-counter drug maker Perrigo last year, already markets a non-prescription progestin-only tablet in the UK.