Rachel Sachs
@rachelsachs.bsky.social
Law professor. Researching and writing about innovation and access to new healthcare technologies, mostly in health law, FDA law, and patent law.
Reposted by Rachel Sachs
Pazdur, a longtime FDA employee, has taken issue with Commissioner Marty Makary's plans to reduce the number of research studies needed to justify more drug-related decisions — with Makary arguing just one study is sufficient.
Also has warned that new Trump drug voucher plan may not be legal.
Also has warned that new Trump drug voucher plan may not be legal.
November 21, 2025 at 10:27 PM
Pazdur, a longtime FDA employee, has taken issue with Commissioner Marty Makary's plans to reduce the number of research studies needed to justify more drug-related decisions — with Makary arguing just one study is sufficient.
Also has warned that new Trump drug voucher plan may not be legal.
Also has warned that new Trump drug voucher plan may not be legal.
Reposted by Rachel Sachs
NEW: FDA review staff was excluded from voting on whether to approve first priority voucher drug. Top leaders like Vinay Prasad, George Tidmarsh, and Tracy Høeg led the vote instead. Read for the full list, and expert reaction from @hollylynchez.bsky.social: www.statnews.com/2025/11/21/t...
FDA review staff was excluded from voting on whether to approve first priority voucher drug
Top officials like Vinay Prasad and George Tidmarsh voted on the drug, a major break from the FDA's typical practice.
www.statnews.com
November 21, 2025 at 4:33 PM
NEW: FDA review staff was excluded from voting on whether to approve first priority voucher drug. Top leaders like Vinay Prasad, George Tidmarsh, and Tracy Høeg led the vote instead. Read for the full list, and expert reaction from @hollylynchez.bsky.social: www.statnews.com/2025/11/21/t...
This is highly misleading. CMS exercised significant discretion in the design of the Rural Health Transformation Program (RHTP) and made a number of substantive choices which were not compelled by Congress. Here are just a few examples. 1/6
Kennedy is getting grilled by governors on the Rural Health Fund and concerns about the fairness of how the $50 billion will be distributed. He responded by distancing himself from it, saying that the House and Senate decided how the program works and he won't be able to change it.
November 21, 2025 at 2:50 AM
This is highly misleading. CMS exercised significant discretion in the design of the Rural Health Transformation Program (RHTP) and made a number of substantive choices which were not compelled by Congress. Here are just a few examples. 1/6
Reposted by Rachel Sachs
Policy merits or demerits aside, it is logistically impossible to set up a brand new HSA scheme in the next six weeks. I suspect it could prove logistically impossible to execute in the next six months.
People are picking their plans for 2026 between now and January 15.
People are picking their plans for 2026 between now and January 15.
Cassidy pitches his alternative to extending extra ACA subsidies
Cassidy wants to replace enhanced ACA subsidies with payments to health savings accounts.
www.statnews.com
November 17, 2025 at 10:43 PM
Policy merits or demerits aside, it is logistically impossible to set up a brand new HSA scheme in the next six weeks. I suspect it could prove logistically impossible to execute in the next six months.
People are picking their plans for 2026 between now and January 15.
People are picking their plans for 2026 between now and January 15.
Thread.
Democrats didn't funnel subsidy dollars directly to insurers because of their great love for industry. It's just the approach that's most user-friendly and administratively efficient.
November 12, 2025 at 5:20 PM
Thread.
"[Prasad] and Høeg have also seized control from career scientists who run the FDA’s vaccine surveillance programs... Prasad and Høeg are changing procedures rapidly and with little input from career staff. They have not discussed their ideas in a public forum..."
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 2:17 PM
"[Prasad] and Høeg have also seized control from career scientists who run the FDA’s vaccine surveillance programs... Prasad and Høeg are changing procedures rapidly and with little input from career staff. They have not discussed their ideas in a public forum..."
Reposted by Rachel Sachs
As the ~discourse~ seems to bend interminably towards Republicans trying to figure out how they can (further) HDHP-ify ACA coverage, it's worth revisiting what is probably our best (most rigorous) study on the effect of deductibles in health insurance.
academic.oup.com/qje/article-...
academic.oup.com/qje/article-...
November 10, 2025 at 9:51 PM
As the ~discourse~ seems to bend interminably towards Republicans trying to figure out how they can (further) HDHP-ify ACA coverage, it's worth revisiting what is probably our best (most rigorous) study on the effect of deductibles in health insurance.
academic.oup.com/qje/article-...
academic.oup.com/qje/article-...
Reposted by Rachel Sachs
I don't think that Trump has any specific health care plan to point to — he never has — but Cassidy is a different story.
He was advocating for "Roth HSAs" back in 2017 and 2017, in the lead up to the ACA's near-repeal.
From Tim Jost in 2017:
He was advocating for "Roth HSAs" back in 2017 and 2017, in the lead up to the ACA's near-repeal.
From Tim Jost in 2017:
ACA Replacement Bill From Cassidy And Colleagues Offers State Options, Roth HSAs | Health Affairs Forefront
A new ACA replacement plan from Senators Cassidy, Collins, Isakson, and Capito gives states three choices. They can 1) keep the ACA (more or less); 2) adopt a different approach based on subsidized “R...
www.healthaffairs.org
November 9, 2025 at 6:22 PM
I don't think that Trump has any specific health care plan to point to — he never has — but Cassidy is a different story.
He was advocating for "Roth HSAs" back in 2017 and 2017, in the lead up to the ACA's near-repeal.
From Tim Jost in 2017:
He was advocating for "Roth HSAs" back in 2017 and 2017, in the lead up to the ACA's near-repeal.
From Tim Jost in 2017:
Glad to join the @healthaffairs.bsky.social This Week podcast to discuss my recent Forefront article with Kristi Martin about the 2028 Medicare Drug Price Negotiation final guidance. It's timely, as we await the announcement of the 2027 negotiated prices. www.healthaffairs.org/do/10.1377/h...
Podcast: CMS Drug Price Negotiation Guidance Updates with Rachel Sachs | Health Affairs Podcast
Health Affairs' Jeff Byers welcomes Rachel Sachs from Washington University in St. Louis and Deputy Editor Chris Fleming back to the pod to discuss CMS' final guidance for the latest round of the Medi...
www.healthaffairs.org
November 7, 2025 at 5:31 PM
Glad to join the @healthaffairs.bsky.social This Week podcast to discuss my recent Forefront article with Kristi Martin about the 2028 Medicare Drug Price Negotiation final guidance. It's timely, as we await the announcement of the 2027 negotiated prices. www.healthaffairs.org/do/10.1377/h...
Reposted by Rachel Sachs
Lots of thoughts regarding today's White House announcements on drug pricing policies for GLP-1s and the Medicaid drug pricing model. But clouding all of this are the 4 patients I saw today in clinic who asked me about food pantries due to their SNAP benefits being cut and... #MedSky
November 7, 2025 at 3:12 AM
Lots of thoughts regarding today's White House announcements on drug pricing policies for GLP-1s and the Medicaid drug pricing model. But clouding all of this are the 4 patients I saw today in clinic who asked me about food pantries due to their SNAP benefits being cut and... #MedSky
There are a lot of very interesting design choices in this model. A brief thread. 1/4
November 6, 2025 at 10:34 PM
There are a lot of very interesting design choices in this model. A brief thread. 1/4
1: "In return for dropping prices, Novo and Lilly each received a priority review voucher, which guarantees a regulatory decision within one to two months." Also 2: "agency watchdogs have worried that the program may primarily be a way to hand out political favors rather than advance public health."
NEW: FDA announces six new recipients of priority vouchers, including GLP-1s from Eli Lilly and Novo Nordisk. Most of the recipients have already received some type of FDA approval.
www.statnews.com/2025/11/06/f...
www.statnews.com/2025/11/06/f...
FDA announces next round of priority review vouchers
The FDA announced the second batch of companies being granted a “Commissioner’s National Priority Voucher,” a ticket to speedier drug reviews.
www.statnews.com
November 6, 2025 at 7:34 PM
1: "In return for dropping prices, Novo and Lilly each received a priority review voucher, which guarantees a regulatory decision within one to two months." Also 2: "agency watchdogs have worried that the program may primarily be a way to hand out political favors rather than advance public health."
Drug pricing law/policy experts have many questions going into this announcement. For those watching, here are just a few important ones. 1. What's the form of the "deal"? Is it a model through CMMI (as suggested in @ddiamond.bsky.social's reporting)? How enforceable is the deal (and by whom)? 1/6
Trump has long been fixated on the "fat pill," the "fat drug," the "fat shot," the "fat killer" — you get the idea.
(He's also questioned if the drugs work.)
Today Trump will announce a deal with Eli Lilly and Novo Nordisk in the Oval Office to lower the price of some of their drugs. More to come.
(He's also questioned if the drugs work.)
Today Trump will announce a deal with Eli Lilly and Novo Nordisk in the Oval Office to lower the price of some of their drugs. More to come.
Trump, long fixated on ‘fat drug,’ to announce deal to lower its price
The president has cited the high cost of GLP-1 drugs, which help with weight loss, as his go-to example in his push to reduce U.S. drug prices.
www.washingtonpost.com
November 6, 2025 at 2:51 PM
Drug pricing law/policy experts have many questions going into this announcement. For those watching, here are just a few important ones. 1. What's the form of the "deal"? Is it a model through CMMI (as suggested in @ddiamond.bsky.social's reporting)? How enforceable is the deal (and by whom)? 1/6
Important new analysis from @matthewherper.bsky.social and @lizzylawrence.bsky.social about the ongoing situation at FDA. This quote from an agency staffer sums up the potential concerns. www.statnews.com/2025/11/04/f...
November 4, 2025 at 2:41 PM
Important new analysis from @matthewherper.bsky.social and @lizzylawrence.bsky.social about the ongoing situation at FDA. This quote from an agency staffer sums up the potential concerns. www.statnews.com/2025/11/04/f...
Reposted by Rachel Sachs
Tidmarsh posted on LinkedIn w/ fair concerns abt how FDA uses surrogate endpts. But the drug example he named didn't make sense, except maybe for Tidmarsh's personal connection to that drugmaker's board chair...who has now filed a complaint w/ FDA, after the post caused the co's stock to drop 16%.
November 2, 2025 at 10:17 PM
Tidmarsh posted on LinkedIn w/ fair concerns abt how FDA uses surrogate endpts. But the drug example he named didn't make sense, except maybe for Tidmarsh's personal connection to that drugmaker's board chair...who has now filed a complaint w/ FDA, after the post caused the co's stock to drop 16%.
CDER Director Tidmarsh said "he believed the new [voucher] program injected politics into the drug review program, superseding decisions based on science" and "raised concerns about [its] legal basis." www.nytimes.com/2025/11/02/h... 1/3
F.D.A. Drug Unit Chief Is Placed on Leave, and Cites a ‘Toxic’ Environment
www.nytimes.com
November 2, 2025 at 10:12 PM
CDER Director Tidmarsh said "he believed the new [voucher] program injected politics into the drug review program, superseding decisions based on science" and "raised concerns about [its] legal basis." www.nytimes.com/2025/11/02/h... 1/3
"CBER employees are concerned that the exodus of employees and the worsening morale problems will affect the functioning of the center, which ensures the safety and efficacy of vaccines and helps speed potentially lifesaving therapies to rare disease patients."
EXCLUSIVE: A slow-boiling feud between Vinay Prasad and his staff at the FDA is threatening the future of the center that regulates the nation’s vaccines, biological products, and blood supply. Read more here:
www.statnews.com/2025/10/31/v...
www.statnews.com/2025/10/31/v...
Under Vinay Prasad, employees at a key FDA center fear speaking out, look for the exits
Exclusive: Vinay Prasad has rattled FDA staff by expanding his power and pushing out senior leaders.
www.statnews.com
October 31, 2025 at 2:25 PM
"CBER employees are concerned that the exodus of employees and the worsening morale problems will affect the functioning of the center, which ensures the safety and efficacy of vaccines and helps speed potentially lifesaving therapies to rare disease patients."
Reposted by Rachel Sachs
New: As open enrollment is about to begin, we estimate ACA insurers are raising premiums by an average of 26%. But if enhanced tax credits expire, 22 million enrollees will see their payments increase by way more than that, more than doubling.
www.kff.org/quick-take/a...
www.kff.org/quick-take/a...
October 29, 2025 at 12:51 AM
New: As open enrollment is about to begin, we estimate ACA insurers are raising premiums by an average of 26%. But if enhanced tax credits expire, 22 million enrollees will see their payments increase by way more than that, more than doubling.
www.kff.org/quick-take/a...
www.kff.org/quick-take/a...
Important reporting from @lizzylawrence.bsky.social, finding that "[f]ive companies actively applied, while the other four were surprised to learn they were selected after being nominated by reviewers inside the agency." This is another important way the program has changed without public input. 1/4
NEW: I talked with the nine companies that won FDA priority review vouchers and asked them how they did it: www.statnews.com/2025/10/24/h...
How the first nine drug companies won priority review vouchers from Marty Makary’s FDA
The winners include a gene therapy for a rare form of deafness, a drug for vaping addiction, and a generic antibiotic.
www.statnews.com
October 24, 2025 at 7:32 PM
Important reporting from @lizzylawrence.bsky.social, finding that "[f]ive companies actively applied, while the other four were surprised to learn they were selected after being nominated by reviewers inside the agency." This is another important way the program has changed without public input. 1/4
Excited to see this published as part of @jhppl.bsky.social's 50th anniversary edition! The balance between the role of the government and the private sector even in traditionally public programs has continued to evolve in ways which may become even more important in the future.
@rachelsachs.bsky.social & Allison Hoffman examine the government's changing role in health law, with expanding role of the private sector in public insurance & enactment of ACA. They argue that the government's regulatory power may be constrained moving forward. read.dukeupress.edu/jhppl/articl...
The Changing Role of the Government in American Health Law | Journal of Health Politics, Policy and Law | Duke University Press
read.dukeupress.edu
October 23, 2025 at 3:53 PM
Excited to see this published as part of @jhppl.bsky.social's 50th anniversary edition! The balance between the role of the government and the private sector even in traditionally public programs has continued to evolve in ways which may become even more important in the future.
CBO has now revised its estimate of the reconciliation law's expansion of the orphan drug exemption to the Medicare Drug Price Negotiation Program, increasing its estimated cost from $4.9 billion to $8.8 billion. A few thoughts. 1/4
www.cbo.gov/publication/...
www.cbo.gov/publication/...
Revised Estimate of Changes Under the 2025 Reconciliation Act for Exemptions From Medicare Price Negotiations for Orphan Drugs
CBO responds to questions regarding the orphan drug exemption under Public Law 119-25, the 2025 reconciliation act.
www.cbo.gov
October 20, 2025 at 3:40 PM
CBO has now revised its estimate of the reconciliation law's expansion of the orphan drug exemption to the Medicare Drug Price Negotiation Program, increasing its estimated cost from $4.9 billion to $8.8 billion. A few thoughts. 1/4
www.cbo.gov/publication/...
www.cbo.gov/publication/...
FDA has updated their CBER/CDER net hiring data for FY 2025. Although both Centers grew in FY2023 and FY2024, in FY2025 they've lost ~16-18% (respectively) of staff, over a thousand people at CDER alone. www.fda.gov/industry/fda...
October 17, 2025 at 6:16 PM
FDA has updated their CBER/CDER net hiring data for FY 2025. Although both Centers grew in FY2023 and FY2024, in FY2025 they've lost ~16-18% (respectively) of staff, over a thousand people at CDER alone. www.fda.gov/industry/fda...
FYI to other FDA National Priority Voucher watchers: yes, the July version of the website did say that "no more than 5" vouchers would be given out "during the initial year." (Screenshot below.) That language is not present in the current version of the website. www.fda.gov/industry/com...
October 16, 2025 at 8:52 PM
FYI to other FDA National Priority Voucher watchers: yes, the July version of the website did say that "no more than 5" vouchers would be given out "during the initial year." (Screenshot below.) That language is not present in the current version of the website. www.fda.gov/industry/com...
Reposted by Rachel Sachs
Great reporting by @lizzylawrence.bsky.social.
Great, insightful quotes from @reshmagar.bsky.social, @nathancortez.bsky.social & @rachelsachs.bsky.social.
Not great news, to say the least, for public health, innovation, or any of us.
Great, insightful quotes from @reshmagar.bsky.social, @nathancortez.bsky.social & @rachelsachs.bsky.social.
Not great news, to say the least, for public health, innovation, or any of us.
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 8:01 PM
Great reporting by @lizzylawrence.bsky.social.
Great, insightful quotes from @reshmagar.bsky.social, @nathancortez.bsky.social & @rachelsachs.bsky.social.
Not great news, to say the least, for public health, innovation, or any of us.
Great, insightful quotes from @reshmagar.bsky.social, @nathancortez.bsky.social & @rachelsachs.bsky.social.
Not great news, to say the least, for public health, innovation, or any of us.