Brendan O'Leary
@boleary.com
Engineer, MedTech consultant, and former regulator.
(he/him)
(he/him)
Reposted by Brendan O'Leary
RFK Jr. has said he does not want to take vaccines away from Americans. But at a closed-door meeting of vaccine scientists in September, a top official at the FDA suggested doing just that. Here's how Vinay Prasad and Tracy Beth Høeg are reshaping vaccine regulation:
www.statnews.com/2025/11/12/f...
www.statnews.com/2025/11/12/f...
How two top FDA officials are quietly upending vaccine regulations
Vinay Prasad and Tracy Beth Høeg mix skepticism with new ways to define risk in pursuing sweeping changes to vaccine policy at the FDA.
www.statnews.com
November 12, 2025 at 1:42 PM
RFK Jr. has said he does not want to take vaccines away from Americans. But at a closed-door meeting of vaccine scientists in September, a top official at the FDA suggested doing just that. Here's how Vinay Prasad and Tracy Beth Høeg are reshaping vaccine regulation:
www.statnews.com/2025/11/12/f...
www.statnews.com/2025/11/12/f...
@lizzylawrence.bsky.social published a big one today: www.statnews.com/2025/11/12/f...
How two top FDA officials are quietly upending vaccine regulations
Vinay Prasad and Tracy Beth Høeg mix skepticism with new ways to define risk in pursuing sweeping changes to vaccine policy at the FDA.
www.statnews.com
November 12, 2025 at 2:49 PM
@lizzylawrence.bsky.social published a big one today: www.statnews.com/2025/11/12/f...
Reposted by Brendan O'Leary
Van Hollen Senate Minority Leader vote when
November 10, 2025 at 3:37 AM
Van Hollen Senate Minority Leader vote when
Reposted by Brendan O'Leary
BREAKING: FDA’s top drug regulator George Tidmarsh has been placed on leave after being accused of abusing his regulatory authority - but also after he questioned the commissioner's plan to speed approvals, and clashed with Vinay Prasad. More here:
www.statnews.com/2025/11/02/f...
www.statnews.com/2025/11/02/f...
FDA’s top drug regulator placed on leave amid investigation
George Tidmarsh, the FDA's top drug regulator, has been placed on leave after being accused of abusing his regulatory authority, STAT has learned.
www.statnews.com
November 2, 2025 at 10:11 PM
BREAKING: FDA’s top drug regulator George Tidmarsh has been placed on leave after being accused of abusing his regulatory authority - but also after he questioned the commissioner's plan to speed approvals, and clashed with Vinay Prasad. More here:
www.statnews.com/2025/11/02/f...
www.statnews.com/2025/11/02/f...
I’m reading the materials for the FDA’s upcoming Digital Health Advisory Committee meeting, and it sure seems like the FDA may be looking to actively regulate LLM therapy bots.
October 30, 2025 at 6:39 PM
I’m reading the materials for the FDA’s upcoming Digital Health Advisory Committee meeting, and it sure seems like the FDA may be looking to actively regulate LLM therapy bots.
Reposted by Brendan O'Leary
Rhode Island opened window shopping today for 2026 ACA marketplace plans. Because of expiring premium tax credit enhancements, a typical 60-year-old couple making $85,000 will have to pay an additional $18,600 annually for benchmark coverage. (1/4)
October 23, 2025 at 1:22 PM
Rhode Island opened window shopping today for 2026 ACA marketplace plans. Because of expiring premium tax credit enhancements, a typical 60-year-old couple making $85,000 will have to pay an additional $18,600 annually for benchmark coverage. (1/4)
Reposted by Brendan O'Leary
This. The president can't extort corporations to pay essentially taxes to him personally so that he can use that money at his personal discretion to do government work.
It flies under the radar because it is overwhelmed by the sheer repulsiveness of the physical destruction of the east wing, but there is no way that a president should be allowed to use private money to change public property. It circumvents the power of the purse.
October 23, 2025 at 12:47 AM
This. The president can't extort corporations to pay essentially taxes to him personally so that he can use that money at his personal discretion to do government work.
There were so many veterans downtown yesterday. Inspiring and not at all surprising.
October 19, 2025 at 2:26 PM
There were so many veterans downtown yesterday. Inspiring and not at all surprising.
Politics is an obvious factor in the FDA’s recent decisions. This increases skepticism abroad, hurting businesses who choose the U.S. as their first market. Americans’ access to safe and effective new drugs, biologics, and devices depends on the quality and credibility of the FDA’s decisions.
Exclusive: How political pressure is shaping the work of the FDA, from searching for autism treatments to heavily focusing on Covid-19 vaccine adverse events. Read for more details on how the leucovorin decision came about, in particular:
www.statnews.com/2025/10/14/f...
www.statnews.com/2025/10/14/f...
Inside FDA, career staffers describe how political pressure is influencing their work
Current and former FDA staff said the level of involvement of political officials in nitty-gritty regulatory matters is unprecedented.
www.statnews.com
October 14, 2025 at 2:28 PM
Politics is an obvious factor in the FDA’s recent decisions. This increases skepticism abroad, hurting businesses who choose the U.S. as their first market. Americans’ access to safe and effective new drugs, biologics, and devices depends on the quality and credibility of the FDA’s decisions.
Reposted by Brendan O'Leary
If you're wondering whether or not to get a flu shot, I didn't get one in time, and I just had a fever dream where I was in the Drew Carey Show because several days ago I was on the Wikipedia page for the Drew Carey Show. You don't have to do this to yourself.
October 13, 2025 at 11:00 PM
If you're wondering whether or not to get a flu shot, I didn't get one in time, and I just had a fever dream where I was in the Drew Carey Show because several days ago I was on the Wikipedia page for the Drew Carey Show. You don't have to do this to yourself.
This is “like driving a car that you know is not being maintained. For now, the car works fine, but one day it will break down. And when it does, the moment to repair the car will have passed.”
Outstanding essay by my colleague Gisela Salim-Peyer
Authoritarianism Feels Surprisingly Normal—Until It Doesn’t
Life in Venezuela was deceptively mundane. Then everything collapsed.
www.theatlantic.com
October 3, 2025 at 9:27 PM
This is “like driving a car that you know is not being maintained. For now, the car works fine, but one day it will break down. And when it does, the moment to repair the car will have passed.”
Reposted by Brendan O'Leary
After ICE agents violently detained a man in Maryland, they kept him pinned to the ground for nine minutes.
He shouts “I live in America! I love America!”
When a witness asks why the man was arrested, the officer shouts “Because he’s a criminal.”
Full story: www.thehandbasket.co/p/ice-agents...
He shouts “I live in America! I love America!”
When a witness asks why the man was arrested, the officer shouts “Because he’s a criminal.”
Full story: www.thehandbasket.co/p/ice-agents...
September 26, 2025 at 4:42 PM
After ICE agents violently detained a man in Maryland, they kept him pinned to the ground for nine minutes.
He shouts “I live in America! I love America!”
When a witness asks why the man was arrested, the officer shouts “Because he’s a criminal.”
Full story: www.thehandbasket.co/p/ice-agents...
He shouts “I live in America! I love America!”
When a witness asks why the man was arrested, the officer shouts “Because he’s a criminal.”
Full story: www.thehandbasket.co/p/ice-agents...
“…it’s hard to ignore the Trump administration’s drift toward a quasi-socialist statism, seizing ownership from private shareholders, dictating staffing, and selectively blocking moves into strategic markets based upon politics and kickbacks.”
September 22, 2025 at 3:38 AM
“…it’s hard to ignore the Trump administration’s drift toward a quasi-socialist statism, seizing ownership from private shareholders, dictating staffing, and selectively blocking moves into strategic markets based upon politics and kickbacks.”
Reposted by Brendan O'Leary
Reposted by Brendan O'Leary
It’s easier to purchase an assault rifle in the U.S. than it is to get a COVID19 vaccine.
But food dyes and wearable fitness monitors are going to fix everything.
But food dyes and wearable fitness monitors are going to fix everything.
August 29, 2025 at 10:38 PM
It’s easier to purchase an assault rifle in the U.S. than it is to get a COVID19 vaccine.
But food dyes and wearable fitness monitors are going to fix everything.
But food dyes and wearable fitness monitors are going to fix everything.
Reposted by Brendan O'Leary
Dear people who are saying that the CDC directors who quit yesterday should have “stayed and fought”,
With all due respect, you do not grasp the magnitude of the problem of RFK Jr.
He is asking them to do unethical and immoral things that will actively harm the people of the United States. 1/3
With all due respect, you do not grasp the magnitude of the problem of RFK Jr.
He is asking them to do unethical and immoral things that will actively harm the people of the United States. 1/3
August 28, 2025 at 4:19 PM
Dear people who are saying that the CDC directors who quit yesterday should have “stayed and fought”,
With all due respect, you do not grasp the magnitude of the problem of RFK Jr.
He is asking them to do unethical and immoral things that will actively harm the people of the United States. 1/3
With all due respect, you do not grasp the magnitude of the problem of RFK Jr.
He is asking them to do unethical and immoral things that will actively harm the people of the United States. 1/3
Reposted by Brendan O'Leary
We have to talk about this also as an insult to the National Guard, who are being used as political props by the President and governors. They signed up to serve their country and their communities, and are now being turned into playthings of a political operation. It’s a slap in the face.
Updated this story @taskandpurpose.com. Ohio and South Carolina are joining West Virginia in sending National Guard troops in DC. That brings the number of Guardsmen activated for this to ~1,500. taskandpurpose.com/news/west-vi...
3 states sending 700 National Guard troops to DC
At least 700 National Guard troops will be sent to Washington, D.C., nearly doubling the number of Guardsmen active in the capital.
taskandpurpose.com
August 17, 2025 at 1:44 AM
We have to talk about this also as an insult to the National Guard, who are being used as political props by the President and governors. They signed up to serve their country and their communities, and are now being turned into playthings of a political operation. It’s a slap in the face.
"The U.S. computing research ecosystem is a national treasure that has delivered unparalleled economic and security benefits. This executive order puts that entire system at risk."
cra.org/govaffairs/b...
cra.org/govaffairs/b...
CRA Issues Statement on President’s Executive Order on Federal Grants
In response to the recently issued executive order on federal grantmaking, the Computing Research Association released the following statement opposing the action and warning of its potential harm …
cra.org
August 15, 2025 at 6:37 PM
"The U.S. computing research ecosystem is a national treasure that has delivered unparalleled economic and security benefits. This executive order puts that entire system at risk."
cra.org/govaffairs/b...
cra.org/govaffairs/b...
Reposted by Brendan O'Leary
BREAKING: Vinay Prasad is out at FDA www.statnews.com/2025/07/29/v...
Vinay Prasad departs the FDA
A top FDA official is out after less than 3 months on the job.
www.statnews.com
July 30, 2025 at 1:04 AM
BREAKING: Vinay Prasad is out at FDA www.statnews.com/2025/07/29/v...
Reposted by Brendan O'Leary
FDA’s cancer review team overseeing breast and gynecological products has lost about 1/3 of its medical review staff and the malignant heme group will lose about 2/3 of its medical review staff—all to voluntary resignations clustered among seasoned reviewers
insights.citeline.com/pink-sheet/a...
insights.citeline.com/pink-sheet/a...
July 26, 2025 at 1:57 PM
FDA’s cancer review team overseeing breast and gynecological products has lost about 1/3 of its medical review staff and the malignant heme group will lose about 2/3 of its medical review staff—all to voluntary resignations clustered among seasoned reviewers
insights.citeline.com/pink-sheet/a...
insights.citeline.com/pink-sheet/a...
Potential coordinated investigational use ("regulatory sandboxes") of AI/ML-enabled medical devices is featured in the action plan the White House published today.
www.whitehouse.gov/wp-content/u...
www.whitehouse.gov/wp-content/u...
July 23, 2025 at 9:47 PM
Potential coordinated investigational use ("regulatory sandboxes") of AI/ML-enabled medical devices is featured in the action plan the White House published today.
www.whitehouse.gov/wp-content/u...
www.whitehouse.gov/wp-content/u...
I’ll keep getting my blood pressure insights from a well-validated technology that has been reviewed and cleared by the FDA. It doesn’t surprise me that the FDA believes it has a role to play in ensuring that these technologies provide accurate results.
July 17, 2025 at 9:58 PM
I’ll keep getting my blood pressure insights from a well-validated technology that has been reviewed and cleared by the FDA. It doesn’t surprise me that the FDA believes it has a role to play in ensuring that these technologies provide accurate results.
Reposted by Brendan O'Leary
The FDA on Thursday published more than 200 letters that it sent to companies when it rejected their medicines — but only letters that have already been made public, for drugs that were ultimately approved.
www.statnews.com/2025/07/10/f...
www.statnews.com/2025/07/10/f...
FDA publishes rejection letters sent to drugmakers, with a big caveat
The FDA published more than 200 letters that it sent to companies when it rejected their medicines, but the letters came with a caveat.
www.statnews.com
July 10, 2025 at 4:33 PM
The FDA on Thursday published more than 200 letters that it sent to companies when it rejected their medicines — but only letters that have already been made public, for drugs that were ultimately approved.
www.statnews.com/2025/07/10/f...
www.statnews.com/2025/07/10/f...
Reposted by Brendan O'Leary
DOJ just issued ~20 subpoenas to clinics that provide gender-affirming care and to drug manufacturers who make testosterone and estrogen. More about what this means and the larger federal push to halt such care, from @theresagaff.bsky.social
www.statnews.com/2025/07/09/d...
www.statnews.com/2025/07/09/d...
Justice Department issues subpoenas to clinics and drugmakers over gender-affirming care
A Justice Department official said it has issued “nearly 20 subpoenas” to clinics that provide gender-affirming care.
www.statnews.com
July 9, 2025 at 9:41 PM
DOJ just issued ~20 subpoenas to clinics that provide gender-affirming care and to drug manufacturers who make testosterone and estrogen. More about what this means and the larger federal push to halt such care, from @theresagaff.bsky.social
www.statnews.com/2025/07/09/d...
www.statnews.com/2025/07/09/d...