World News | Over-the-counter birth control pills face problems with US FDA

WASHINGTON, May 6 (AP) — U.S. health regulators are weighing the first-ever request to make a birth control pill available without a prescription.

But in a preliminary review released Friday, the FDA raised numerous concerns about drugmaker Perrigo’s application to sell its decades-old pill over the counter.

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The FDA cited issues with the reliability of some of the company’s data on the drug, Opill, and questioned whether women with certain other medical conditions would rightly choose not to take it. It also noted signs of difficulty understanding label instructions among study participants.

Advisers to the U.S. Food and Drug Administration meet next week to review drugmaker Perrigo’s application to sell a decades-old pill over the counter. The two-day public meeting is one of the final steps before the FDA makes a decision.

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If the FDA approves the company’s request, Opill would be the first birth control pill to move from behind the pharmacy counter to store shelves or online.

An FDA review on Friday revealed the regulator has serious reservations about the drug’s widespread use, including whether young teens can properly follow label directions.

At the end of the meeting, the FDA panel will vote on whether the benefits of making the pill more widely available outweigh the potential risks. The panel vote is non-binding, and the FDA is expected to make a final decision this summer.

Perrigo executives say Opill could be an important new option for the estimated 15 million American women, or one in five women of childbearing age, who currently do not use birth control or use less effective forms such as condoms. method.

“Without a doubt, our data clearly show that women of all ages can safely use Opill over-the-counter,” Frederique Welgryn, the company’s global vice president of women’s health, said this week.

The company’s filing is unrelated to ongoing litigation over the abortion drug mifepristone, which is not a birth control pill. Research into over-the-counter sales of pills began nearly a decade ago.

Hormone pills, such as Opill, have long been the most common birth control pill in the United States, used by tens of millions of women since the 1960s.

Opill was first approved in the United States 50 years ago. Perrigo acquired rights to the drug last year through its acquisition of Paris-based HRA Pharma, which bought the drug from Pfizer in 2014.The drug is not currently available in the US but is available without a prescription in the UK

The FDA decision does not apply to other birth control pills, only Opill, though advocates hope the approval decision may prompt other pill makers to seek over-the-counter sales. Birth control pills are available without a prescription in most of South America, Asia, and Africa.

Many common medications have been converted to over-the-counter options, including those for pain, heartburn, and allergies. Typically, drugmakers must demonstrate that consumers accurately understand and follow label directions to use the drug safely and effectively. Over-the-counter medications are usually cheaper, but are usually not covered by insurance. Mandatory insurance companies to cover over-the-counter birth control pills would require regulatory reform by the Department of Health and Human Services.

Perrigo’s main study followed nearly 900 American women who took the drug for up to six months without professional supervision. This group includes women of different ages, races, educational and cultural backgrounds.

Women are paid to track and record their use of the pill, including whether they take it within the same three-hour window each day as directed. This consistency is key to the drug’s ability to prevent pregnancy.

But after Perrigo completed the study, the FDA discovered a problem: Nearly 30 percent of women incorrectly reported taking more pills than were actually supplied.

These “impossible dose” cases cast doubt on the company’s results, the FDA said Friday.

Perrigo will perform a reanalysis of the data excluding overreported participants. The company said the results showed the study still achieved its goal of proving that most women use the pill correctly.

During the study period, 92 percent of women reported taking the pill daily, the company said.

The company said its data showed about two pregnancies for every 100 women who took its birth control pill for a year. But the FDA called the figure an “imprecise estimate” because the study was significantly smaller than studies typically used to assess contraceptive effectiveness.

Today’s most popular birth control pills contain a combination of the synthetic hormones progesterone and estrogen that help prevent pregnancy. Adding estrogen can help make periods lighter and more regular, but it also carries a risk of rare blood clots.

Opill contains only progestin, making it a safer option and, according to experts, easier for regulation to shift to over-the-counter. But progestin-only pills have drawbacks, including being less effective if not taken at the same time of day each day.

The FDA review also pointed to concerns that women with underlying medical conditions would appropriately avoid taking the drug.

Women with a history of breast cancer should not be on the pill, although some participants in the pilot study incorrectly said they thought they could. Women with abnormal vaginal bleeding are asked to see a doctor first, as this may indicate a medical problem. But the FDA noted that half of the women in the Perrigo study who had unexplained bleeding mistakenly believed that Opill was right for them.

Several major U.S. medical groups, including the American Medical Association, support over-the-counter sales of the drugs. In comments submitted to the FDA, the group said the 60-year history of the pill shows that “the benefits of widespread over-the-counter use far outweigh the limited risks.”

Catholic groups, including the U.S. Conference of Catholic Bishops, opposed Opill’s application, saying women should be evaluated by a doctor before undergoing treatment. (Associated Press)

(This is an unedited and auto-generated story from a Syndicated News feed, the content body may not have been modified or edited by LatestLY staff)