However, KHN and other critics argue that the 3,000-plus closed-door meetings that take place annually between industry and a captured FDA foster a relationship that is a bit too cozy.

During COVID-19, the public learned about the downside of one of the FDA’s industry-friendly workarounds — the Emergency Use Authorization (EUA) — discovering that the shortcut not only allowed the FDA to rush unapproved vaccines into American arms but also kept the jabs on the market despite early and widespread safety signals.

But the FDA’s toolkit of approaches to speed up approvals during ordinary times also deserves scrutiny.

For products it deems to be addressing “unmet medical needs” and “serious conditions,” the agency can draw on the Orphan Drug Act (1983), Accelerated Approval Program (1992), Priority Review (1992), the Fast Track process (1997) and/or the Breakthrough Therapy designation (2012).

Moreover, investigational products often benefit from more than one of these FDA green lights, with 4 of 5 of the New Drug Applications the FDA approves for Fast Track also given Priority Review.

According to the experts interviewed by KHN, the push to get drugs approved more quickly using these programs has clear advantages for companies — but iffy benefits for consumers. As KHN summed it up, “Pharma-Funded FDA Gets Drugs Out Faster, But Some Work Only ‘Marginally’ and Most Are Pricey.”

But poor performance and high cost are not the worst outcomes associated with fast-tracking.

As even an industry-favorable publication pointed out in 2017, “Fast Track and other expedited review programs unnecessarily rush drug approvals without sufficient safety data,” with the result that nearly 3 of 5 (57%) Fast-Track-approved drugs end up needing to add black box warnings.

In a 2018 article, “FDA Repays Industry by Rushing Risky Drugs to Market,” ProPublica confirmed that while the FDA may “review and approve drugs faster than any other regulatory agency in the world,” the “aftermath” can be deadly.

Watching these drug approval trends, a survivor of the disastrous drug thalidomide warned in 2015, “We could be returning to a time in which physicians had little way of knowing if their prescriptions would help or harm their patients.”

Click the covers to order:

The Real Anthony Fauci Bill Gates, Big Pharma, and the Global War on Democracy and Public Health (Children’s Health Defense) by Robert Kennedy, Jr.
Pharma-funded mainstream media has convinced millions of Americans that Dr. Anthony Fauci is a hero. Hands down, he is anything but.



Lies My Government Told Me by Dr. Robert Malone
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With contributions from eminent doctors, scientists, and experts in their fields, Lies My Gov't Told Me offers a comprehensive look at the coronavirus pandemic–where we are today, how we got here, and what's on the horizon. Challenging the mainstream government-pharma-media narrative, the chapters in this book will not only outrage readers but will also inform and give readers hope.

Cause Unknown: The Epidemic of Sudden Deaths in 2021 & 2022 by Ed Dowd
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What is killing young healthy Americans? Edward Dowd, a former Wall Street analyst and BlackRock portfolio manager, examines the epidemic of sudden deaths in America.