FDA

From the Musk/Trump Administration's Health & Human Services (HHS) Dept:

Washington, D.C. — March 27, 2025 — Today, the U.S. Department of Health and Human Services (HHS) announced a dramatic restructuring in accordance with President Trump's Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.”

The restructuring will address this and serve multiple goals without impacting critical services. First, it will save taxpayers $1.8 billion per year through a reduction in workforce of about 10,000 full-time employees who are part of this most recent transformation. When combined with HHS’ other efforts, including early retirement and Fork in the Road, the restructuring results in a total downsizing from 82,000 to 62,000 full-time employees.

That's 20,000 people, or 24% of the HHS Dept's total workforce who are losing their jobs, many of whom are in departments which are currently understaffed.

As a follow-up to my index of links to archived versions of every CDC.gov page available prior to the Musk/Trump purge, I (with the help of others) have created a similar index of direct links to the Internet Archive's most recent mirrored versions of every public-facing web page on the Food & Drug Administration's website (FDA.Gov) prior to content being purged.

At least...as far as I know...the links are from on or shortly before January 27, 2025. It's possible that they were already tinkering with and/or deleting pages/data prior to then.

I've significantly improved the interface for the FDA links: Instead of simply lumping all the links together, 500 to a page the way I did for the CDC, this time I've broken all of the links out into major topics as well as creating a drop-down menu for the topics to make it easier to navigate. 

 

April 2023:

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.

As widely expected, just one day after the Food & Drug Administration (FDA) approved updated mRNA COVID-19 vaccines to help battle the XBB.1.5 strain of the disease, a panel of Centers for Disease Control (CDC) advisors have also given the updated vaccine their blessing. All that's left now is for CDC director Mandy Cohen (who was newly appointed as of July 10th) to sign off on it in order for distribution to the general public to begin. Via NPR:

A panel of advisers to the Centers for Disease Control and Prevention backed the broad use of new COVID-19 vaccines, as cases of the respiratory illness rise.

The advisers voted 13-1 to recommend the vaccines for people ages 6 months and older. While the benefits appear to be greatest for the oldest and youngest people, the benefits of vaccination exceed the risks for everyone, according to a CDC analysis.

via the U.S. Food & Drug Administration:

FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants

Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.

What You Need to Know

A few days ago, a federal Trump-appointed district court judge in Louisiana ruled that the federal government is no longer allowed to fight disinformation online in a devastating ruling:

District Court Judge Terry Doughty, who was appointed by President Donald Trump, issued a preliminary injunction on Tuesday that bars several federal departments and agencies from various interactions with social media companies.

On Wednesday, the Justice Department filed a notice that it will appeal the injunction with the Fifth Circuit Court of Appeals in New Orleans. The government also expects to ask the court to stay the district judge's decision, meaning it would not go into effect while the appeal is heard.

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.

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