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NEWS PROVIDED BY
Life Legal Defense Foundation
May 11, 2023
NAPA, Calif., May 11, 2023 /Christian
Newswire/ -- 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.
SOURCE Life Legal Defense Foundation
CONTACT: Alexandra Snyder, 202-717-7371