The hottest FDA Substack posts right now

And their main takeaways
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Top Science Topics

The Disgraceful Campaign Against a Top FDA Official

Common Sense with Bari Weiss • 1521 implied HN points • 31 Jul 25
🇺🇸 U.S. Politics FDA
  1. Dr. Vinay Prasad was appointed to an important role in the FDA aimed at improving public trust in health officials. His scientific background and independence were seen as valuable assets.
  2. One of Prasad's early decisions was to stop recommending Covid-19 vaccinations for young children, reflecting his criticism of government overreach during the pandemic.
  3. Prasad resigned after facing intense pressure from a smear campaign involving various influential figures, which suggests challenges in maintaining integrity in public health leadership.

AHM v. FDA reaches the Supreme Court

Adam's Legal Newsletter • 499 implied HN points • 28 Mar 24
🇺🇸 U.S. Politics FDA
  1. Plaintiffs in the case lack standing, which weakens their argument. They need to show personal harm, not just philosophical opposition.
  2. Even if plaintiffs had standing, their claims fail on the merits. The FDA's decisions were well-reasoned and based on evidence, debunking plaintiffs' objections.
  3. Banning mifepristone won't help the plaintiff-doctors study it; rather, it will hinder data collection. The FDA's evaluation of studies appears rational and reasonable.
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Mifepristone and the rule of law, part II

Adam's Legal Newsletter • 2037 implied HN points • 10 Apr 23
🇺🇸 U.S. Politics FDA
  1. The district court's decision to overturn the FDA's approval of mifepristone is based on a variety of reasons, such as standing, timeliness, exhaustion, and the merits of the FDA's actions.
  2. The court assessed issues like the criteria for standing, timeliness of the lawsuit, the exhaustion of legal claims, and the agency's compliance with regulations.
  3. In examining the merits, the court questioned the FDA's safety analysis, imposition of restrictions, political influences, and the reasoning behind decisions made over a span of decades.

Mifepristone and the rule of law, part III

Adam's Legal Newsletter • 1377 implied HN points • 13 Apr 23
🇺🇸 U.S. Politics FDA
  1. The US Court of Appeals for the Fifth Circuit partially granted the FDA's motion regarding mifepristone, subjecting it to pre-2016 regulatory requirements.
  2. The Fifth Circuit's decision was criticized for its analysis of standing, with concerns raised about statistical certainty and the potential harm to doctors.
  3. The court's reasoning on timeliness and exhaustion was questioned, with issues seen as less relevant due to the stay on the 2000 approval of mifepristone. The argument that the FDA violated the Administrative Procedure Act was also discussed.

Sunday Strip: Just say No

Who is Robert Malone • 41 implied HN points • 30 Nov 25
🏥 Health Politics FDA
  1. It's important to say 'no' sometimes, especially when you see something is wrong. Dr. Frances Kelsey did this when she refused to approve the dangerous drug thalidomide.
  2. Standing firm in your beliefs can protect others from harm. Kelsey's refusal to approve drugs without proper safety testing saved countless babies from serious deformities.
  3. Dr. Kelsey's work helped change drug approval laws. She showed that patient safety comes first, and her courage led to better protections for everyone.

MenQuadfi Approval and the Pyramid Scheme of Vaccine Safety

Injecting Freedom • 46 implied HN points • 15 Jun 25
🏥 Health Politics FDA
  1. The FDA approved the MenQuadfi vaccine for infants based on a study that compared it to another vaccine, Menveo, even though both showed serious side effects.
  2. There's a chain reaction of approvals where previous vaccines are used as controls without proper safety testing, creating a cycle that's hard to break.
  3. The safety standards for these vaccines are questionable, as the FDA relies on the very companies selling the vaccines to explain away any serious problems.

Robert Califf the FDA commissioner is making inappropriate and irresponsible claims about vaccines and boosters on twitter

Vinay Prasad's Observations and Thoughts • 176 implied HN points • 04 Jan 24
🏥 Health Politics FDA
  1. FDA commissioner Robert Califf is making inappropriate claims about vaccines and boosters on Twitter.
  2. Califf's claims are not supported by randomized trials, which go against FDA standards.
  3. Califf is spreading misinformation and using low quality evidence, acting more like a Pfizer spokesperson than a respected academic and scholar.

Happy holidays from Boutique Biotech!

Boutique Biotech • 19 implied HN points • 26 Dec 23
🔬 Science FDA
  1. Bristol Myers Squibb acquired Karuna Therapeutics for $14B, expanding their pipeline.
  2. Karuna's lead asset is currently under FDA review with a PDUFA date set for Sept. 26, 2024.
  3. The post is exclusive for paid subscribers of Boutique Biotech.

A Top FDA Official Makes Stunning Admission About Initial COVID Vaccine Approval

Unmasked • 102 implied HN points • 01 Mar 24
🏥 Health Politics FDA
  1. COVID vaccines have faced challenges like waning protection, ineffective boosters, and increased side effect risks.
  2. The CDC approved multiple additional vaccine doses, bringing the total up to nine, but none guarantee protection against infection or transmission.
  3. Recent congressional testimony raised concerns about the early days of COVID vaccine approval.

Clinical Trial to License RotaTeq, Like Almost All Childhood Vaccines, Did Not Use a Placebo Control

Injecting Freedom • 80 implied HN points • 25 Jun 23
🏥 Health Politics FDA
  1. Most childhood vaccines were licensed without using a placebo control in their clinical trials.
  2. The clinical trial for RotaTeq did not use a true placebo as the control group, but included bioactive ingredients.
  3. Robert F. Kennedy, Jr. advocates for vaccine safety and freedom of choice without restricting access to vaccines.

ICAN Acquires Critical FDA Safety Reports Concerning COVID-19 Vaccines + VAERS URF computation

Steve Kirsch's newsletter • 13 implied HN points • 22 Jan 25
🏥 Health Politics FDA
  1. The FDA's safety monitoring for COVID-19 vaccines is considered inadequate, as it hasn't identified any serious issues despite many reports of adverse events.
  2. A significant portion of reports in the VAERS system comes from COVID-19 vaccines, indicating potential underreporting in the system that needs addressing.
  3. There are serious concerns about the number of excess deaths related to COVID-19 vaccinations, with many not reported, raising alarms about the transparency of vaccine safety data.

I finally was able to talk to a top official at FDA media relations live. Here's what happened...

Steve Kirsch's newsletter • 12 implied HN points • 15 Mar 24
🏥 Health Politics FDA
  1. The individual made multiple attempts to contact the FDA regarding various concerns, but did not receive any response.
  2. Despite lack of response, the individual was able to connect with a live member of FDA media relations leadership and presented their offer for a public dialog to address differences.
  3. While unsure of FDA's willingness to engage in public discussion, the individual finds the connection made with FDA media relations leadership intriguing.

Cholesterol Politics

Harnessing the Power of Nutrients • 0 implied HN points • 05 Feb 09
🏥 Health Politics FDA
  1. The post discusses the war on cholesterol as a war on freedom, covering issues like the National Animal Identification System, Codex Alimentarius, and the Campaign Against Raw Milk.
  2. The site plans to address conflicts of interest, the pharmaceutical industry, and the FDA's revolving door, along with the Federal Reserve in the future.
  3. The focus is on exploring how various factors impact health freedom and choices.

The Journal of the American Medical Association Finally Questions Whether the FDA Should be Approving Useless No-Evidence Cholesterol-Lowering Drugs

Harnessing the Power of Nutrients • 0 implied HN points • 21 Jan 10
🏥 Health & Wellness FDA
  1. The evidence suggests that drugs lowering cholesterol may not actually prevent heart attacks by lowering cholesterol, but by clearing LDL from the bloodstream more quickly.
  2. The FDA approved cholesterol-lowering drugs based on their ability to lower cholesterol levels, without concrete evidence of preventing heart disease.
  3. Recent studies have suggested that some cholesterol-lowering drugs like ezetimibe may not effectively prevent heart disease, sparking questions about the approval process and physician prescribing practices.