FDA to offer faster drug reviews to companies promoting 'national priorities'

[BumRushDaShow]

Source: WTAE-TV Pittsburgh, PA/AP

Updated: 8:02 PM EDT Jun 17, 2025


WASHINGTON — U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting “the health interests of Americans,” under a new initiative announced Tuesday. Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to “challenge assumptions” and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct “rapid or instant reviews," pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed.

For the new program, the FDA will issue a limited number of “national priority vouchers” to companies “aligned with U.S. national priorities,” the agency said in a statement. The special designation will give the selected companies access to extra FDA communications, streamlined staff reviews and the ability to submit much of their product information in advance.

Speeding up drug approvals has long been a priority of the pharmaceutical industry, which has successfully lobbied Congress to create a variety of special programs and pathways for faster reviews. Many aspects of the plan announced Tuesday overlap with older programs. But the broad criteria for receiving a voucher will give FDA officials unprecedented discretion in deciding which companies can benefit from the fastest reviews.

Read more: https://www.wtae.com/article/fda-fast-drug-approval-voucher-program/65091142

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They laid off most of the Reviewers in CDER and even fired (and then had to rehire) the PDUFA-funded Reviewers, so how do they propose to accomplish this nonsense?

From the OP article -

the agency will aim to review select drugs in one to two months. FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

Impossible. It's basically a "hand-wave" approval.

[bucolic_frolic]

1. National priorities .....

from these clowns I take that to mean Right-Wing Conversion pills

[Ferrets are Cool]

2. Bottom line: If it makes someone rich even more rich, it gets approved.

[OldBaldy1701E]

8. BINGO!!! (n/t)

[NotHardly]

12. Gonna get people killed for profit, or should I say get more people killed

[Bernardo de La Paz]

3. tRump command & control economy, otherwise known as fascism (look up definition)

The aspects of fascism most people think of (restricted freedoms) are not specific to fascism but rather to authoritarianism, which shows up in nazism and communism (in all or almost all variants tried).

Fascism includes the close coordination of companies, which remain functional but are subject to command by the national government. In communism, companies (to the extent they remain companies) are owned by the state. Both have strict control of freedom.

[3Hotdogs]

4. The U.S. had few, or no thalidomide birth defects because the drug's approval process was more

thorough and took more time than the trials in other nations.

Go on MSNBC and watch the drug commercials and pay attention to the "side effects" of these modern marvels.

[purple_haze]

5. Madness and insanity

[odins folly]

6. In other words...

Kiss the giant skid marked ass and tell him how wonderful and benevolent he is and you get a quick approval.

Don’t bend the knee and your drugs will never get tFDA approved….

[progree]

7. Threat in your medicine cabinet: The FDA's gamble on America's drugs

Threat in your medicine cabinet: The FDA’s gamble on America’s drugs , ProPublica via Minnesota Public Radio website, 6/17/25

https://www.mprnews.org/story/2025/06/17/threat-in-your-medicine-cabinet-the-fdas-gamble-on-americas-drugs

In the part I read (about half of it), there were horribly egregious contamination, sanitation, and quality problems at an India pharma manufacturing company, but the FDA allowed some of its products to continue to be made and sold in the U.S. I'm sorry this is a lousy summary, but I never asked to be born. But here we are

The part I read is pre-Trump II. Uggh that the situation is going to get a lot worse.

ETA first paragraphs:

On a sweltering morning in western India in 2022, three U.S. inspectors showed up unannounced at a massive pharmaceutical plant surrounded by barricades and barbed wire and demanded to be let inside.

For two weeks, they scrutinized humming production lines and laboratories spread across the dense industrial campus, peering over the shoulders of workers at the tablet presses, mixers and filling machines that produce dozens of generic drugs for Americans.

Much of the factory was supposed to be as sterile as an operating room. But the inspectors discovered what appeared to be metal shavings on drugmaking equipment, and records that showed vials of medication that were “blackish” from contamination had been sent to the United States. Quality testing in some cases had been put off for more than six months, according to their report, and raw materials tainted with unknown “extraneous matter” were used anyway, mixed into batches of drugs.

Sun Pharma’s transgressions were so egregious that the Food and Drug Administration imposed one of the government’s harshest penalties: banning the factory from exporting drugs to the United States.

But the agency, worried about medication shortages, immediately undercut its mission to ensure the safety of America’s drug supply.

[BumRushDaShow]

9. I felt sorry for the Investigators who had to do foreigns in India

and in some cases, during monsoon season.

This is the problem of Raygunomics and "outsourcing" / "offshoring".

Both India and China supply most of big pharmas bulk "APIs" - "Active Pharmaceutical Ingredients" and those are used in formulations with other stuff (fillers) to make finished dosage forms (tablets, capsules, etc). The big one in India is "Dr. Reddy's" and they have always had issues.

But since big pharma refuses to have us make bulk product here due to cost (labor and otherwise), this is how it is.

[patphil]

10. promoting the "health interests of Ameriica"?

Translation: promoting the financial interests of Pharmaceutical Corporations.

Except in extreme emergencies, where time costs lives, there isn't any real health benefit in shortening the review process. There is, however, a real benefit in insuring a thorough review process.
Unfortunately, with all the cuts in staff at the FDA, there aren't enough people to do the kind of thorough review that new drugs need to insure safety and efficacy.
I worked in the QC/QA section of a large Pharmaceutical Company for 36 years. I often participated in FDA inspection and review of documents related to drug testing. The whole process of new drug application (NDA), review, and approval is quite extensive and complex. It's better to take the time to do it right than to rush the approval through and risk harm to patients.
Corporations are too focused on the bottom line. Return On Investment (ROI) is the name of the game for them. Each month "delay" can cost millions in profits.
The real bottom line is that drastically shortening the final approval process is a bad idea.

[50 Shades Of Blue]

11. *wink wink*