FDA

Huh. The folks at the FDA seem to be quite the busy bees this week:

FDA Finalizes Move to Recommend Individual Risk Assessment to Determine Eligibility for Blood Donations

Today, the U.S. Food and Drug Administration finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV. These questions will be the same for every donor, regardless of sexual orientation, sex or gender. Blood establishments may now implement these recommendations by revising their donor history questionnaires and procedures.

This updated policy is based on the best available scientific evidence and is in line with policies in place in countries like the United Kingdom and Canada. It will potentially expand the number of people eligible to donate blood, while also maintaining the appropriate safeguards to protect the safety of the blood supply.

via Oriana González of Axios:

An FDA advisory panel on Wednesday unanimously endorsed making daily birth control pills available over-the-counter for the first time, following two days of deliberations over whether patient misuse could lead to more unintended pregnancies.

Why it matters: If the FDA follows the recommendation and switches HRA Pharma's Opill away from prescription-only use, it could expand the availability of contraception and deepen partisan rifts over reproductive health in the post-Roe landscape.

HRA Pharma, part of consumer products giant Perrigo, expects a final decision from the FDA to come at some point this summer.

Driving the news: In a 17-0 vote, members of two FDA advisory committees decided that patients can properly follow Opill's labeling instructions — including taking the pill at around the same time every day — without consulting with a health provider.

This happened last week but I was preoccupied with some personal issues and never got around to posting about it. The news is widespread by now but important enough that I figured I should at least give it a mention anyway.

Via the New York Times a few days ago:

The Supreme Court issued a decision on Friday evening that maintained the Food and Drug Administration’s approval of a commonly used abortion pill while an appeal moves forward, the latest development in a fast-moving legal battle that followed a lower court’s ruling that ordered the drug pulled off the market.

Justice Samuel A. Alito Jr. had paused the lower court’s ruling on the pill, mifepristone, but that freeze had been set to expire at midnight. The justices issued their decision about five hours before the deadline.

via the Doctors for America website:

WASHINGTON, D.C. – Doctors for America and the Reproductive Health Coalition have filed a new amicus brief in support of FDA’s approval of the use of mifepristone to end pregnancy through ten weeks gestation.  

The brief, filed in the U.S. Court of Appeals for the Fifth Circuit, is in response to the decision made last week by Judge Kacsmaryk in the case of Alliance for Hippocratic Medicine vs. U.S. Food and Drug Administration (FDA), in which Judge Kacsmaryk ordered the FDA to stay the approval of mifepristone. Both Doctors for America (DFA) and the Reproductive Health Coalition (RHC) are deeply concerned that the decision made by Judge Kacsmaryk is not based on medical science, nor the robust data available. Mifepristone is a medication that has been safely used by physicians and patients for over 20 years, with research showing that adverse events and outcomes are exceedingly rare, occurring in less than a fraction of 1% of cases. 

I was out of town for much of last week (my son's robotics team made it to the state championship) so I'm afraid I'm playing a bit of catch up today, so I kind of missed out on writing about this development which, while expected, is both depressing and enraging. Via the NY Times:

A federal judge in Texas issued a preliminary ruling invalidating the Food and Drug Administration’s 23-year-old approval of the abortion pill mifepristone, an unprecedented order that — if it stands through court challenges — could make it harder for patients to get abortions in states where abortion is legal, not just in those trying to restrict it.

The drug will continue to be available at least in the short-term since the judge, Matthew J. Kacsmaryk, stayed his own order for seven days to give the F.D.A. time to ask an appeals court to intervene.

Less than an hour after Judge Kacsmaryk’s ruling, a judge in Washington state issued a ruling in another case, which contradicted the Texas decision, ordering the F.D.A. to make no changes to the availability of mifepristone in the 18 states that filed that lawsuit.

via Pam Belluck of the New York Times:

For the first time, retail pharmacies, from corner drugstores to major chains like CVS and Walgreens, will be allowed to offer abortion pills in the United States under a regulatory change made Tuesday by the Food and Drug Administration. The action could significantly expand access to abortion through medication.

Until now, mifepristone — the first pill used in the two-drug medication abortion regimen — could be dispensed only by a few mail-order pharmacies or by specially certified doctors or clinics. Under the new F.D.A. rules, patients will still need a prescription from a certified health care provider, but any pharmacy that agrees to accept those prescriptions and abide by certain other criteria can dispense the pills in its stores and by mail order.

This would be a pretty big deal anyway, but given the Supreme Court's recent repeal of Roe vs. Wade, it obviously takes on even more significance.

This is a Big F*cking Deal for millions of people.

July 2021President Biden issued an executive order which, among other things, included this provision:

Hearing Aids: Hearing aids are so expensive that only 14% of the approximately 48 million Americans with hearing loss use them. On average, they cost more than $5,000 per pair, and those costs are often not covered by health insurance. A major driver of the expense is that consumers must get them from a doctor or a specialist, even though experts agree that medical evaluation is not necessary. Rather, this requirement serves only as red tape and a barrier to more companies selling hearing aids. The four largest hearing aid manufacturers now control 84% of the market.

In 2017, Congress passed a bipartisan proposal to allow hearing aids to be sold over the counter. However, the Trump Administration Food and Drug Administration failed to issue the necessary rules that would actually allow hearing aids to be sold over the counter, leaving millions of Americans without low-cost options.

This is a Big F*cking Deal for millions of people.

Last July, President Biden issued an executive order which, among other things, included this provision:

Hearing Aids: Hearing aids are so expensive that only 14% of the approximately 48 million Americans with hearing loss use them. On average, they cost more than $5,000 per pair, and those costs are often not covered by health insurance. A major driver of the expense is that consumers must get them from a doctor or a specialist, even though experts agree that medical evaluation is not necessary. Rather, this requirement serves only as red tape and a barrier to more companies selling hearing aids. The four largest hearing aid manufacturers now control 84% of the market.

In 2017, Congress passed a bipartisan proposal to allow hearing aids to be sold over the counter. However, the Trump Administration Food and Drug Administration failed to issue the necessary rules that would actually allow hearing aids to be sold over the counter, leaving millions of Americans without low-cost options.

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