No surprise…Big Pharma gets unsafe hormonal drug recommended for OTC sale…including to children

Yesterday, a panel of “expert” advisors voted to recommend that the FDA allow the birth control drug “Opill” to be sold over the counter (OTC) without a prescription. The FDA is expected to approve the OTC sale of Opill this summer, even though FDA reviewers expressed concerns about the safety of dispensing the drug without a prescription. 

“Opill” is the proprietary name for the hormonal birth control drug norgestrel, which is manufactured by the French pharmaceutical company HRA Pharma. HRA Pharma was recently acquired by Irish “self-care” company Perrigo, which is facing a host of legal problems, including securities violations, lawsuits over failed medical products, baby formula recalls, and misleading financial statements. Perrigo’s stock rose 4.5% yesterday after the announcement that the FDA would likely approve HRA Pharma’s bid to sell Opill without a prescription.

A panel of 17 “expert” advisors reviewed a 130-page briefing document provided by FDA reviewers before unanimously approving Opill for OTC sales. The FDA cites numerous concerns about the safety of the drug as well as concerns about the ability of users – especially young girls – to know when the drug could cause dangerous, even deadly, complications.

For example, the drug manufacturer’s actual use study revealed that “a substantial portion of individuals” – over 30% – reported taking more of the drug than they were given, which the FDA says should “call into question the reliability of all of the actual use data” provided by HRA Pharma. Moreover, nearly half of the 883 participants in the study dropped out, leaving a small sample size that is not representative of the population likely to use the product. Because of this and other flaws in the manufacturer’s data, the FDA’s briefing document recommends additional safety studies – which the “experts” resolutely rejected.

The FDA found that over 20% of women 18 or older did not understand from the product packaging that they were not to use Opill if they have a history of breast cancer. Over 40% of girls ages 11-14 did not understand that Opill is not an emergency contraceptive and would not prevent pregnancy when used as such. Over 33% of girls did not understand that Opill is not effective unless it is taken at the same exact time every day.

Even if taken correctly, hormonal contraceptives can cause cancer.

In a 2016 Supreme Court case, Life Legal provided the Supreme Court with peer-reviewed studies showing that risks of hormonal birth control include a 4.2-fold increase in incidences of the most aggressive form of breast cancer among women under age 45 and a staggering 6.4-fold increase in the same type of breast cancer in women under 18. Women taking hormonal contraceptives also face a higher risk of heart attacks, cardiovascular disease, cervical cancer, liver cancer, and HIV.

Opill’s packaging does not provide information about the increased risk of breast cancer, nor does it include details about possible interactions with other medications. The Mayo Clinic lists 113 medications that are not recommended for use with progestin-only contraceptives like Opill, including common antibiotics such as amoxycillin as well as supplements like St. John’s Wort. Mayo Clinic’s website on progestin contraceptives repeatedly advises consulting with a physician prior to taking the drug. However, most of the “expert” advisors touted easy access to birth control without the hassle of seeing a doctor as a primary reason for approving Opill for OTC sales.

So, who exactly are these “expert” advisors? The panel is comprised largely of self-described “reproductive justice” activists, including a notorious late-term abortionist and, curiously, a geriatric specialist. Pediatricians were selected as panelists to oppose age limits on Opill’s OTC availability, which means young girls will be able to get hormonal birth control drugs without their parents’ knowledge and without medical oversight. An oncologist and a reproductive health expert testified on behalf of HRA Pharma.

These are some of the panelists and witnesses who insist on making hormonal birth control drugs available to women and young girls without medical oversight:

  • Dr. Katalin Roth is a geriatric and palliative care specialist who claims “we need to trust women” when it comes to deregulating birth control. Roth never addresses the fact that the primary reason for providing Opill over the counter is to make it more readily available to young girls.
  • Kathryn Curtis is a scientist at the Centers for Disease Control and Prevention who has written extensively in favor of removing “barriers” to birth control, “such as in-person visits to a health care provider.” Curtis acknowledges “uncertainty” in the findings regarding the safety of Opill, yet she “would not recommend another actual use study” to determine whether the drug is in fact safe.
  • Dr. Karen Murray is the deputy director of the FDA’s Office of Nonprescription Drugs and admitted “the FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively in the nonprescription setting.” Still, Murray voted to deregulate Opill in the name of “women’s health.”
  • Dr. Elise Berlan is a pediatrician and professor of pediatrics at Ohio State University. She recently wrote a policy statement for the American Academy of Pediatrics arguing that parental notification laws and other abortion restrictions create an impermissible barrier for minor children to access “abortion therapy.”
  • Dr. Eve Espey is an abortionist at the University of New Mexico’s (UNM) Center for Reproductive Health, which commits abortions up to 24 weeks gestation. Espey is a worthy recipient of Planned Parenthood’s Margaret Sanger award.
  • Dr. Pamela Goodwin is an oncologist who says women with a history of breast cancer will be warned by the drug’s label “not to use this if they’ve ever had breast cancer.” Dr. Goodwin testified on behalf of HRA Pharma, which makes Opill.
  • Dr. Anna Glasier is a former abortion clinic director in the UK who is a self-described expert on reproductive medicine. Glasier, who was instrumental in deregulating the morning after pill, told the panel, “Let’s not hold women hostage to having to see a doctor” to get Opill. Glasier testified on behalf of HRA Pharma.

Life Legal strongly opposes approving hormonal birth control drugs for over-the-counter purchase, especially for young girls.

Take Action! Call the FDA at 1-888-463-6332 or email to urge the FDA to reject the advisory panel’s recommendation to make Opill available over the counter.