Lizzy Lawrence
@lizzylawrence.bsky.social
Journalist @statnews.bsky.social, writing about the Food and Drug Administration. Tips welcome! Signal is lizzylaw.53
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...
www.statnews.com/2026/01/06/f...
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.
www.statnews.com
January 6, 2026 at 9:01 PM
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...
www.statnews.com/2026/01/06/f...
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...
www.statnews.com/2026/01/05/c...
Federal health officials slash recommended childhood vaccinations under Trump’s directive
The number of recommended childhood shots drops from 17 to 11.
www.statnews.com
January 5, 2026 at 10:04 PM
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...
www.statnews.com/2026/01/05/c...
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...
www.statnews.com/2025/04/03/f...
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.
www.statnews.com
December 23, 2025 at 5:52 PM
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...
www.statnews.com/2025/04/03/f...
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...
www.statnews.com/2025/12/22/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
www.statnews.com
December 22, 2025 at 2:52 PM
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...
www.statnews.com/2025/12/22/f...
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...
www.statnews.com/2025/12/19/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.
www.statnews.com
December 19, 2025 at 2:25 PM
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...
www.statnews.com/2025/12/19/f...
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...
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.
www.statnews.com
December 18, 2025 at 11:11 PM
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...
Reposted by Lizzy Lawrence
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:
December 18, 2025 at 8:35 PM
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:
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...
www.statnews.com/2025/12/16/i...
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.
www.statnews.com
December 16, 2025 at 3:09 PM
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...
www.statnews.com/2025/12/16/i...
Reposted by Lizzy Lawrence
“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...
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...
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.
www.statnews.com
December 8, 2025 at 2:51 PM
“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...
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...
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...
www.statnews.com/2025/12/11/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.
www.statnews.com
December 11, 2025 at 11:41 PM
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...
www.statnews.com/2025/12/11/t...
It was an honor to join this conversation. You can watch below:
🔴 LIVE NOW: Join our conversation about how sources’ fear of retaliation can muzzle facts, featuring @lizzylawrence.bsky.social, @gracehussain.bsky.social, @fastlerner.bsky.social, Emily Spatz, @harloholm.es and @caitlinvogus.bsky.social.
Watch: www.youtube.com/watch?v=rIyR...
Watch: www.youtube.com/watch?v=rIyR...
December 9, 2025 at 8:52 PM
It was an honor to join this conversation. You can watch below:
Reposted by Lizzy Lawrence
🔔 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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December 8, 2025 at 8:14 PM
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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...
www.statnews.com/2025/12/04/v...
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.
www.statnews.com
December 4, 2025 at 9:09 PM
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...
www.statnews.com/2025/12/04/v...
Reposted by Lizzy Lawrence
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.
December 4, 2025 at 4:29 PM
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.
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...
www.statnews.com/american-sci...
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
www.statnews.com
December 4, 2025 at 2:48 PM
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...
www.statnews.com/american-sci...
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...
www.statnews.com/2025/12/04/f...
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.
www.statnews.com
December 4, 2025 at 1:24 PM
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...
www.statnews.com/2025/12/04/f...
Reposted by Lizzy Lawrence
And if you're wondering who Tracy Beth Høeg is, @lizzylawrence.bsky.social already has a profile for you:
www.statnews.com/2025/05/19/t...
www.statnews.com/2025/05/19/t...
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.
www.statnews.com
December 4, 2025 at 12:17 AM
And if you're wondering who Tracy Beth Høeg is, @lizzylawrence.bsky.social already has a profile for you:
www.statnews.com/2025/05/19/t...
www.statnews.com/2025/05/19/t...
BREAKING: Tracy Beth Høeg will lead the FDA's drug center. W/ @ChelseaCirruzzo www.statnews.com/2025/12/03/t...
Tracy Beth Høeg, Makary aide who investigated Covid vaccines, to lead FDA drug center
Tracy Beth Høeg, a top lieutenant to Food and Drug Administration Commissioner Marty Makary, will be the next leader of the Center for Drug Evaluation and Research.
www.statnews.com
December 4, 2025 at 12:12 AM
BREAKING: Tracy Beth Høeg will lead the FDA's drug center. W/ @ChelseaCirruzzo www.statnews.com/2025/12/03/t...
12 former FDA commissioners denounce Vinay Prasad's internal memo on vaccine regulation, from
@matthewherper.bsky.social: www.statnews.com/2025/12/03/f...
@matthewherper.bsky.social: www.statnews.com/2025/12/03/f...
A dozen former FDA commissioners decry Prasad memo on vaccine regulation
Changes to the ways in which the FDA plans to regulate vaccines represent a threat to effective vaccines and public health, 12 former commissioners say.
www.statnews.com
December 3, 2025 at 10:36 PM
12 former FDA commissioners denounce Vinay Prasad's internal memo on vaccine regulation, from
@matthewherper.bsky.social: www.statnews.com/2025/12/03/f...
@matthewherper.bsky.social: www.statnews.com/2025/12/03/f...
Reposted by Lizzy Lawrence
🔔 Journalists’ sources fear retaliation. We’re all less informed as a result. Join our live webinar with @lizzylawrence.bsky.social, @gracehussain.bsky.social, @fastlerner.bsky.social, Emily Spatz, @harloholm.es and @caitlinvogus.bsky.social.
🗓️ Dec. 9, 2 pm ET
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December 3, 2025 at 6:23 PM
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🗓️ Dec. 9, 2 pm ET
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BREAKING: The FDA just removed longtime over-the-counter drug regulator Theresa Michele from her role, just a day after her boss, Rick Pazdur, announced he was retiring. Pazdur had pushed back on efforts from the commissioner to replace career staff.
www.statnews.com/2025/12/03/t...
www.statnews.com/2025/12/03/t...
FDA removes longtime over-the-counter drugs regulator from her position
The move comes a day after Richard Pazdur, a top FDA official and Michele’s boss, announced his decision to retire.
www.statnews.com
December 3, 2025 at 8:36 PM
BREAKING: The FDA just removed longtime over-the-counter drug regulator Theresa Michele from her role, just a day after her boss, Rick Pazdur, announced he was retiring. Pazdur had pushed back on efforts from the commissioner to replace career staff.
www.statnews.com/2025/12/03/t...
www.statnews.com/2025/12/03/t...
Reposted by Lizzy Lawrence
🔔 Journalists’ sources fear retaliation. We’re all less informed as a result. Join our live webinar with @lizzylawrence.bsky.social, @gracehussain.bsky.social, @fastlerner.bsky.social, Emily Spatz, @harloholm.es and @caitlinvogus.bsky.social.
🗓️ Dec. 9, 2 pm ET
RSVP: freedom.press/silenced-sou...
🗓️ Dec. 9, 2 pm ET
RSVP: freedom.press/silenced-sou...
December 2, 2025 at 9:03 PM
🔔 Journalists’ sources fear retaliation. We’re all less informed as a result. Join our live webinar with @lizzylawrence.bsky.social, @gracehussain.bsky.social, @fastlerner.bsky.social, Emily Spatz, @harloholm.es and @caitlinvogus.bsky.social.
🗓️ Dec. 9, 2 pm ET
RSVP: freedom.press/silenced-sou...
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Reposted by Lizzy Lawrence
STAT's @lizzylawrence.bsky.social had quite a scoop this morning- the FDA's top regulator is retiring after just under a month on the job. @statnews.com www.statnews.com/2025/12/02/r...
December 2, 2025 at 7:36 PM
STAT's @lizzylawrence.bsky.social had quite a scoop this morning- the FDA's top regulator is retiring after just under a month on the job. @statnews.com www.statnews.com/2025/12/02/r...
Reposted by Lizzy Lawrence
RICK PAZDUR is now planning to resign at the end of the year — three weeks after taking the job as FDA's top drug regulator.
Big shake-up after a year of turbulence at the agency.
Story w @rachelroubein.bsky.social.
(And credit to Stat's @lizzylawrence.bsky.social, who beat us out the door.)
Big shake-up after a year of turbulence at the agency.
Story w @rachelroubein.bsky.social.
(And credit to Stat's @lizzylawrence.bsky.social, who beat us out the door.)
December 2, 2025 at 5:06 PM
RICK PAZDUR is now planning to resign at the end of the year — three weeks after taking the job as FDA's top drug regulator.
Big shake-up after a year of turbulence at the agency.
Story w @rachelroubein.bsky.social.
(And credit to Stat's @lizzylawrence.bsky.social, who beat us out the door.)
Big shake-up after a year of turbulence at the agency.
Story w @rachelroubein.bsky.social.
(And credit to Stat's @lizzylawrence.bsky.social, who beat us out the door.)
BREAKING scoop: Top drug regulator Rick Pazdur filed papers to retire from the FDA at the end of this month, according to agency sources. He alerted leaders at the drug center this morning. He could still withdraw the papers. www.statnews.com/2025/12/02/r...
Top drug regulator Richard Pazdur set to leave FDA
Top drug regulator Richard Pazdur filed papers to retire from the Food and Drug Administration at the end of this month, but could withdraw them.
www.statnews.com
December 2, 2025 at 4:10 PM
BREAKING scoop: Top drug regulator Rick Pazdur filed papers to retire from the FDA at the end of this month, according to agency sources. He alerted leaders at the drug center this morning. He could still withdraw the papers. www.statnews.com/2025/12/02/r...