WASHINGTON–
The first-ever request to make a contraceptive pill widely available without a prescription in the United States is being considered by health officials.
The Food and Drug Administration (FDA) issued a preliminary examination of pharmaceutical Perrigo’s application to market a pill that has been in use for decades without a prescription.
The Food and medicine Administration raised concerns about the reliability of certain of the company’s data on the medicine Opill and whether or not women with certain other medical problems would effectively withdraw from using it. It also remembered indicators indicating trial participants had trouble understanding the labelling instructions.
Perrigo, a pharmaceutical company, has applied to the FDA to make a pill that has been around for decades available without a prescription, and FDA advisors will be meeting next week to discuss the proposal. The FDA’s last steps before making a decision include a public meeting that will span two days.
Opill would make history as the first birth control pill to be sold without a prescription if the FDA approves the company’s request.
According to Friday’s FDA review, authorities should have serious reservations about widespread access to the medicine, including whether or not younger adolescents will be able to adequately follow the labelling requirements.
The FDA panel will decide at the end of the meeting on whether or not the benefits of expanding access to the pill outweigh the risks associated with doing so. The panel’s vote is not binding, and a final judgement from the FDA is expected this summer.
According to Perrigo management, An estimated 15 million American women, or around 20% of those of childbearing age, do not use any kind of contraception or rely on less effective methods like prophylactics.
Our data clearly shows that women of all ages may use Opill in an OTC context without risk,” Frederique Welgryn, the company’s international v.p. for women’s health, said in a statement released today.
Mifepristone is not a contraceptive, thus the company’s application has nothing to do with the ongoing litigation around the abortion pill. The investigation into the tablet’s potential for sale without a doctor’s prescription began some years ago.
Tens of thousands of American women have used hormone-based pills like Opill since the 1960s, making them the most popular method of birth control in the country.
Fifty years ago, Opioid was first approved for use in the United States. In 2015, Perrigo acquired Paris-based HRA Pharma, which had acquired the pill from Pfizer the previous year. It is not commercially available in the United States at this time but is available over the counter in the United Kingdom.
Although some have high hopes that the FDA’s clearance decision will encourage other tablet manufacturers to pursue non-prescription sales, it will only apply to Opill. In many parts of South America, Asia, and Africa, you may get a contraceptive pill without a doctor’s prescription.
Common medicines such as those for pain, heartburn, and allergies are now available without a prescription at local pharmacies. Manufacturers of pharmaceuticals are often required to provide evidence that patients will be able to read and understand the product labelling and use the medication safely and effectively. Non-prescription drugs are cheaper overall, but insurance seldom pays for them. The Department of Health and Human Services would need to amend its regulations if it wanted insurance companies to pay for nonprescription contraception.
Primary research conducted by Perrigo followed over 900 American women who used their pill without medical supervision for around 6 months. The women in the organisation represented a wide range of ages, ethnicities, educational levels, and cultural traditions.
Women were compensated to monitor and report their pill intake, including compliance with the recommendation that it be taken at the same 3-hour window each day. The drug’s effectiveness in preventing pregnancy depends on its ability to maintain such constancy.
Almost 30% of women incorrectly reported taking more pills than they were actually offered, a problem the FDA discovered after Perrigo hid the results of its study.
On Friday, the FDA said these instances of “unlikely dosing” raise questions about the reliability of the company’s findings.
Perrigo will publish a new study that does not include the data from those who inflated their numbers. According to the company, the results showed the study still achieved its goal of demonstrating that many women used the tablet appropriately.
According to the company’s findings, 92% of female participants in the study reported using the pill daily.
The company claims that its data show that for every 100 women who take its pill for a year, there would be about 2 pregnancies. The FDA referred to this number as “an inaccurate quote” due to the fact that the study was far smaller than the ones typically used to evaluate the efficacy of contraceptives.
Most modern oral contraceptives include oestrogen and the synthetic hormone progestin to prevent pregnancy. Oestrogen supplements may help make periods lighter and more regular, but they also carry the risk of a rare embolism.
Opill is an easier regulatory transfer to OTC status because it contains just progestin, making it a safer option. The effectiveness of progestin-only pills might diminish if they aren’t taken at the same time every day.
Concerns that women who may develop health problems in the future could be dissuaded from using the medicine were also raised in the FDA review.
Although a few participants in the original trial incorrectly indicated they felt they could, women with a history of breast cancer should not take the pill. It’s also important for women to see a doctor if they have unusual vaginal bleeding, as this might be an indicator of a more serious problem. The FDA recalls that half of the women in Perrigo’s trial who reported abnormal bleeding falsely claimed Opill would be appropriate for them.
Many prominent medical organisations in the United States advocate for OTC availability of these medicines; this includes the American Medical Association. The organisation noted to the FDA that the contraceptive pill’s 60-year history shows “the benefits of widespread, nonprescription accessibility far exceed the restricted danger.”
Opill’s application is being opposed by Catholic organisations including the United States Conference of Catholic Bishops on the grounds that women should get a medical checkup beforehand.