NAPA, Calif. -- 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 after FDA reviewers expressed concerns about the lack of adequate safety studies.
"Opill" is the proprietary name for the hormonal birth control drug norgestrel, which is manufactured by French pharmaceutical company HRA Pharma. HRA Pharma was recently acquired by Perrigo, a "self-care" company facing a host of legal woes, including securities violations, lawsuits over failed medical products, baby formula recalls, and misleading financial statements.
A panel of 17 "expert" advisors reviewed a 130-page briefing document provided by FDA reviewers before unanimously recommending Opill for OTC sales. The briefing document cites numerous concerns about the safety of the drug as well as concerns about the ability of women – 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 amoxicillin 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. Pro-abortion 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.
Click here to learn more about the panelists and witnesses.
"Life Legal strongly opposing approving hormonal birth control drugs for over-the-counter purchase, especially for young girls," said Life Legal CEO Alexandra Snyder. "There is no valid justification for encouraging girls to ingest hormones that have known detrimental health effects. Once again, abortion ideologues have allowed their dogma to supersede science, common sense, and concern for the safety of women and children."
About Life Legal Defense Foundation
Life Legal Defense Foundation was established in 1989, and is a nonprofit organization composed of attorneys and other concerned citizens committed to giving helpless and innocent human beings of any age, and their advocates, a trained and committed voice in the courtrooms of our nation. For more information about the Life Legal Defense Foundation, visit www.lldf.org.