Lizzy Lawrence

Chaotic and politicized: Inside the FDA under TrumpIndividual Layoffs, leadership chaos, and politicized science have destabilized the FDA under Trump. This STAT Special Report explains what happened, why it matters, and what comes next.

Hmm, it is showing up for me! Does this work? reports.statnews.com/products/ins...

Chaotic and politicized: Inside the FDA under Trump Layoffs, leadership chaos, and politicized science have destabilized the FDA under Trump. This STAT Special Report explains what happened, why it matters, and what comes next.

NEW: You can now access all of STAT's most important FDA reporting from last year in one place. Check out our special report documenting the agency's inner turmoil.
reports.statnews.com/products/ins...

You can buy a whole host of sketchy drugs at many gas stations. I wondered why gas stations, of all places, were the premier destination for people seeking quasi-legal recreational (or knockoff pharmaceutical) drugs. I dig into why in this week's @statnews.com STATus Report. youtu.be/4QsVjgIWVZs

I previously reported on the company's sketchy billing/oversupplying practices in 2024: www.statnews.com/2024/06/04/z...

Former executives of device maker Zynex Medical indicted for fraud Former executives of device maker Zynex Medical were indicted for fraud this week.

Former executives of pain management device company Zynex Medical were indicted on multiple counts of fraud this week
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Holy shit. HHS says the Africa CDC "is a powerless, fake organization attempting to manufacture credibility by repeating its claims publicly. It is not a reliable source, and its statements should be treated accordingly."

Scoop: The leaked protocol of the CDC-funded Hepatitis B vaccine trial in Guinea-Bissau. “This is another Tuskegee.” The protocol reveals that the trial will withhold the Hepatitis B birth dose from thousands—without placebos, without universal maternal screening, and with endpoints critics call indefensible.

We have the CDC-funded Hepatitis Vaccine trial in Guinea-Bissau protocol.

It’s worse than you thought.

Check it out, first in Inside Medicine…

with @pauloffit.bsky.social David Boulware and others.

insidemedicine.substack.com/p/scoop-the-...

Kennedy adds two OB-GYNs to vaccine advisory panel amid review of shots for pregnant women ACIP is reviewing the shots recommended for pregnant women as RFK Jr. upends federal vaccine policy.

NEW: Kennedy added two OB-GYNs to vaccine advisory panel amid review of shots for pregnant women. Their names are Adam Urato and Kimberly Biss. Learn more about them here: www.statnews.com/2026/01/13/n...

Pazdur warns that politics, ‘chaos’ are damaging FDA At a STAT event, veteran drug regulator Richard Pazdur, who left the FDA last month after 26 years, said that politics and 'chaos' were damaging the agency.

Read @elaineywchen.bsky.social's write-up of former top FDA drug regulator Rick Pazdur's explosive panel at STAT's event at #JPM2026 last night, moderated by @matthewherper.bsky.social. Drug makers should be more concerned by what's happening at FDA, Pazdur said. www.statnews.com/2026/01/13/r...

When it comes to vaccine schedules, the U.S. is now the outlier A STAT analysis of vaccine recommendations in 38 countries suggests the U.S. is now an outlier.

Important reporting from @HelenBranswell and @jaspar: The US is now a global outlier when it comes to vaccine schedules, recommending fewer vaccines than most of its peers. www.statnews.com/2026/01/09/c...

Growing number of House Republicans support enhanced ACA subsidies This is the web edition of D.C. Diagnosis, STAT's twice-weekly newsletter about the politics and policy of health and medicine.

Full edition of the newsletter is here: www.statnews.com/2026/01/08/e...

A little scoopy tidbit in STAT's DC Diagnosis newsletter today: Vinay Prasad wants access to FDA employees' calendars, though his own is largely private. He has also instructed employees not to tell their supervisors when he reaches out to schedule meetings.

Panel behind new dietary guidelines had financial ties to beef, dairy industries The industry connections of an advisory panel for the new dietary guidelines are notable, especially in light Robert F. Kennedy Jr.'s criticism of corporate influence.

Nearly half of Trump-appointed experts involved in shaping the new dietary guidelines have financial ties to meat and dairy industries.

Exclusive with @sarah-todd.bsky.social and @elizabethcooney.bsky.social -->

www.statnews.com/2026/01/07/n...

FDA announces sweeping changes to oversight of wearables, AI-enabled devices The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.

The FDA is easing regulation for wearable devices and AI-enabled clinical decision support tools. Commissioner Makary intro'd the news at #CES2026, telling attendees the FDA will "get out of the way" and "promote AI." Read our news analysis:
www.statnews.com/2026/01/06/f...

Federal health officials slash recommended childhood vaccinations under Trump’s directive The number of recommended childhood shots drops from 17 to 11.

The Trump administration has dramatically slashed the childhood vaccine schedule. Medical experts have called the changes "dangerous and unnecessary." Read our analysis of the news and what it means for public health:
www.statnews.com/2026/01/05/c...

A running list of senior FDA officials who have left the agency Here is a running list of senior FDA officials who have left the agency recently.

As we close out the year, wanted to share this running list of FDA leadership departures one last time. Some new names on there include digital health director Jessica Paulsen, and director of clinical policy in the chief medical office Shari Targum.
www.statnews.com/2025/04/03/f...

3 key issues to watch at FDA as Makary struggles to stabilize the agency 3 key issues to watch at FDA as Makary struggles to stabilize the agency

Here are three key issues to watch at the FDA as Commissioner Makary struggles to stabilize the agency.
www.statnews.com/2025/12/22/f...

FDA voucher program has become vehicle for political interference in drug review decisions, staffers say Two government officials told STAT that the White House has been involved in final decisions about the FDA's new priority review voucher program for drug companies.

EXCLUSIVE: The FDA voucher program has become a vehicle for politicization of drug review, staffers say. Staff have been forced to award certain companies vouchers due to White House deals, and at least one voucher was awarded despite staff concerns.

www.statnews.com/2025/12/19/f...

CDC awards grant to controversial Danish researchers with ties to top FDA official CDC awards grant to controversial Danish researchers with ties to top FDA official Tracy Beth Høeg.

W/ @helenbranswell.bsky.social: The CDC has awarded $1.6 million to controversial Danish researchers with ties to top Food and Drug Administration official Tracy Beth Høeg. The funding is for a study on hepatitis B vaccines that some experts say may be unethical. www.statnews.com/2025/12/18/c...

We updated this story with some insights from lawyers and policy experts on whether or not CMS has the legal authority to do this, what challenges to the rules may look like, and when those challenges can happen. Take a read:

Data on Humana’s clinics looked dismal. Then its corporate research machine got to work STAT investigation: Internal documents show how Humana is reshaping the debate over Medicare Advantage.

Don't miss this investigation from @tarabannow.bsky.social and @caseyross.bsky.social into the way Humana tweaked the presentation of its data to indicate that their corporate business model was the best way to care for older Americans.
www.statnews.com/2025/12/16/i...

NIH shut out hundreds of young scientists from funding to start their own labs Special Report: The NIH has shut out hundreds of young scientists from funding to start their own labs.

“The only reason I don’t have this funding is because my last name is Rodriguez.”

MOSAIC checked many of the boxes of the administration — but that didn't matter. It was terminated, and left grantees scrambling

Next installment of American Science, Shattered:

www.statnews.com/2025/12/08/t...

FDA staff fear Tracy Beth Høeg will bring bias and instability to embattled drug center Høeg is set to become the fifth head of the FDA's drug center in a year.

NEW: I dug deep into new top drug regulator Tracy Beth Høeg's record at the FDA so far, talked to agency staff, and even found some old and interesting blog posts, to get a sense of how she'll lead the drug center. TLDR, staff are worried. More here:
www.statnews.com/2025/12/11/t...

It was an honor to join this conversation. You can watch below:

🔔 We’re all less informed when journalists’ sources fear retaliation. Tomorrow, join our live webinar with @lizzylawrence.bsky.social, @gracehussain.bsky.social, @fastlerner.bsky.social, Emily Spatz, @harloholm.es and @caitlinvogus.bsky.social.

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Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks In a closed meeting, Vinay Prasad pushes back on criticism of his vaccine policy changes, morale issues at the FDA, and his role in recent drug-approval turbulence.

W/ Damian Garde on the ground in NYC: Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks

www.statnews.com/2025/12/04/v...

ICYMI: @lizzylawrence.bsky.social in @statnews.com News scooped that the @fda.gov is planning to require only a single pivotal clinical trial to be the basis of drug approval, rather than 2 or more.

American Science, Shattered An eight-decade partnership between universities and the federal government made U.S. science preeminent. It took Trump less than a year to shred that

I know there's a lot of news but if you can tear yourself away from the CDC vaccine committee today — you should really read this series on how the Trump administration has upended science in just 10 months, from my incredibly talented colleagues:
www.statnews.com/american-sci...

FDA to lower number of trials required for approval of drugs, other medical products The FDA plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration for approval.

NEW: FDA will lower the number of clinical trials required for medical product approval from two to one. I obtained a draft of the press release and got to talk to FDA Commissioner Makary about it, and some other things, yesterday:
www.statnews.com/2025/12/04/f...

Inside the rise of Tracy Beth Høeg, the Covid contrarian shaping FDA vaccine policy Høeg has been skeptical of the safety and value of some vaccines and mandates, raising questions about her approach at the FDA.

Profile I wrote of Hoeg back in May: www.statnews.com/2025/05/19/t...