
FDA Approves OTC Birth Control Pill
An FDA advisory panel voted unanimously last week that Opill, a progestin-only birth control pill, should be available over the counter.
There is another update to the ongoing court battle over mifepristone, one of two drugs used in most medication abortion. As some may remember, by April three different courts had weighed in on two cases involving the drug, and the conflicting decision had people across the country confused as to whether medication abortions were still possible even in states where abortion remained legal.
One of the confusing decisions came from District Court Judge Matthew Kaczmarek’s of Texas who agreed with a group of doctors calling themselves Alliance for Hippocratic Medicine. Their case argued that the process used to approve mifepristone over 20 years ago was unlawful, and that approval should be rescinding. They further argued that more recent changes (in 2016 and 2021) that expanded access had been done without careful consideration of safety and should also be rescinded.
Despite years of evidence that mifepristone is safer than Tylenol or Viagra, Kaczmarek agreed with the plaintiffs that the drug should not have been approved and that the more recent rule changes should also be overturned. Among other spurious arguments, the judge said that the new rules violated the Comstock Act of 1873 which forbid sending “obscene” materials, including contraception, through the mail.
His decision was immediately appealed to the Fifth Circuit Court of Appeals which issued an emergency decision agreeing with part, but not all, of Kaczmarek’s ruling. The appeals court said it was too late to question the original approval of the medication but agreed that the newer rules should be rescinded. They also cited the Comstock Act.
Had this decision been allowed to take hold, even in states where abortion remains legal, mifepristone would only have been available up to 7 weeks of pregnancy (as opposed to 10 weeks) and could not be delivered by mail order.
At the end of April, the Supreme Court issued a stay that put a pause on this decision going into effect. SCOTUS did not discuss the merits of the case. Instead, it sent the case back to the Fifth Circuit for a full review. To avoid ongoing confusion as there are other related case also wending their way through the courts, the Supreme Court said that the stay would remain in place until it decided whether to hear a case on this issue.
Last week, the Fifth Circuit released its full decision in the case which, not surprisingly, echoed what it had said in the spring. The Fifth Circuit is known to be very conservative and the three judges who heard this case had ruled against abortion rights in the past.
Again, the Supreme Court’s stay means that nothing changes yet, but the Fifth Circuit’s most recent decision makes it even more likely that the highest court will hear this case at some point soon. Nearly half of all abortions in this country are medication abortions and that may be increasing as providers in states where abortion is still available become more and more overwhelmed. The Supreme Court’s decision on this case will have significant ramifications for abortion access as well as the future of the FDA’s authority to regulate drugs.
For a more thorough discussion of the mifepristone court cases and how we got to this point please see this article.
An FDA advisory panel voted unanimously last week that Opill, a progestin-only birth control pill, should be available over the counter.
For those with insurance coverage, internal condoms can now be ordered for free online and shipped directly.
ASHA recognizes each February as National Condom Month! Time to learn more about condoms, lube, and safer sex.
LARC methods are safe, reliable, and prevent pregnancy for years. For many people they are a great choice, but they aren’t the best choice for everyone, of course, as people have personal preferences for what fits in to their lifestyle and health profile.
Nearly all women use birth control at some point in their lives, and soon they’ll have one more option available. On May 22, the U.S. Food and Drug Administration (FDA) approved Phexxi, a non-hormonal contraceptive gel that works by keeping the pH levels in the vagina acidic, and thus inhospitable to sperm.
The Female Condom Gets a New Name The FDA has reclassified this contraceptive option as the “internal condom.” . Good news for sexual health advocates: in a final order issued
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