FDA committee vote on pill without prescription


Oral contraception Opill

Source: dog

A panel of Experts | Who advises them Food and Drug Administration unanimously recommended on Wednesday that the agency should, for the first time, allow women to purchase birth control pills without a prescription.

The panel was asked whether the benefits of selling HRA Pharma’s birth control pill outweigh the risks of misuse of the drug by consumers, which would result in an unwanted pregnancy.

The FDA is not required to follow the recommendations of its independent advisors, all 17 of whom voted “yes” in favor of the proposal.

HRA Pharma expects a final decision from the FDA this summer on its application to sell Opill, commonly referred to as norgestrel, over-the-counter.

The Paris-based drugmaker is owned Perrigoa manufacturer of over-the-counter medicines.

If approved, Opill would be the first over-the-counter birth control pill in the US since oral contraceptives were approved more than 60 years ago.

This would allow women to get the pill without having to see a doctor or other healthcare provider first.

The FDA originally approved norgestrel as a prescription drug in 1973. However, according to the agency, the company stopped selling the pill in the US in 2005 for business reasons.

HRA Pharma updated the pill’s label in 2017 in hopes of reintroducing the drug to the US market, specifically as an over-the-counter drug.

Medical associations like the American College of Obstetricians and Gynecologists have been pushing for years to allow birth control pills to be sold over-the-counter

More than 50 members of congress demanded in March 2022 FDA Commissioner Dr. Robert Califf to ensure that the agency reviews applications for over-the-counter birth control pills promptly.

“This is a critical issue for reproductive health, rights and justice,” lawmakers wrote in a letter to Califf.

“Despite decades of proven safety and effectiveness, people still face enormous barriers to contraception due to systemic inequalities in our healthcare system.”

According to a study in 2011, almost half of all pregnancies in the United States were unwanted New England Journal of Medicine Study published in 2016.

According to this study, 75% of all pregnancies in girls aged 15 to 19 were unwanted.

HRA Pharma filed its application with the FDA last summer, two weeks after the Supreme Court abolished federal abortion rights by overturning its landmark 1973 Roe vs. Wade ruling.

The Roe vs. Wade case led some states to ban abortion or severely restrict the procedure. It also led to legal efforts to take abortion drugs off the US market.

Shrinking access to abortion in the US, in turn, prompted renewed calls for expanded access to birth control to prevent unwanted pregnancies.

FDA questions company data

Norgestrel contains a hormone called progestin, which prevents pregnancy by thickening cervical mucus, preventing sperm from reaching and fertilizing an egg. The pill should be taken at the same time every day.

Progestogen-only pills are typically taken by women who, for health reasons, do not want to take the more common combination pills that contain progestin and estrogen.

According to the American College of Obstetricians and Gynecologists, progestin-only pills are an effective birth control method, but it’s important to take the pill at the same time each day.

According to the Medical Association, with typical practice, around 9 out of 100 women become pregnant in the first year of taking the pill. If the patient never forgets to take a pill, less than 1 in 100 women will become pregnant in the first year.

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However, FDA scientists have raised concerns about whether the general public, particularly adolescents and those with lower literacy levels, will understand norgestrel’s drug labeling and use the drug properly.

The FDA also found that one-third of the participants in the HRA Pharma study reported taking more norgestrel pills than were actually dispensed.

dr Theresa Michele, head of the FDA’s Nonprescription Drugs Division, said these errors questioned the reliability of other data in the study.

“I can’t think of a study that has 30% invalid data,” Michele told the committee on Wednesday. “That doesn’t happen in any study, let alone a consumer study of this nature – so it’s really quite extraordinary.”

“We went back and asked the sponsor to look for the root cause of this, but they couldn’t find it,” Michele said.

dr Karen Murry, deputy director of the FDA’s Office of Non-Prescription Drugs, said the agency recognizes the importance of improving women’s access to effective birth control. But Murry said HRA Pharma presented a study that was difficult to interpret.

“As a result, the FDA has been placed in a very difficult position in determining whether women are likely to use this product safely and effectively in the nonprescription setting,” Murry said.

“Let’s not take women hostage”

The FDA was also concerned that some women with a history of breast cancer chose to take norgestrel to understand drug labeling, despite warnings from HRA Pharma. Progestin can increase the risk of breast cancer coming back.

The agency’s scientists were also concerned that some women with unexplained vaginal bleeding between menstrual cycles chose to take norgestrel without first consulting a doctor.

dr Pamela Goodwin, an oncologist at the University of Toronto, told the committee Tuesday that most women diagnosed with breast cancer are older than 50 and above childbearing age.

There is a small population of women of childbearing potential who have been diagnosed with breast cancer and may want to use oral contraception, but they are in constant contact with their doctor and are unlikely to take any medication that increases their risk of the cancer coming back would, said Goodwin.

“The breast cancer population is very concerned about avoiding recurrence,” said Goodwin, speaking for HRA Pharma. “They have been warned by their doctors and are warned again on the label not to use this if they have ever had breast cancer.”

dr Anna Glasier, an expert in reproductive medicine, told the committee on Tuesday that most women don’t see a doctor about unexplained vaginal bleeding because these episodes are common and usually resolve spontaneously. Glasier also testified on behalf of HRA Pharma.

“Let’s not hold women hostage to having to see a doctor to get this extremely safe and effective POP,” Glasier said, referring to progestogen-only birth control pills like norgestrel.


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