Staff told Pazdur that "this administration had issued 'an edict' that reviewers will meet all deadlines." Given the large-scale firings/departures at FDA, it's important to ask how prioritizing review deadlines might negatively impact other key agency activities. endpoints.news/former-fda-c...

Glad to join @sbagen.bsky.social and @drsinhaesq.bsky.social on this panel at @nusl.bsky.social's annual health law conference, with very thoughtful moderation from @davidasimon.bsky.social. Thanks to @doritreiss.bsky.social for liveposting!

In @jama.com we estimate how many newly eligible Part D enrollees could be covered under the #CMMI BALANCE model for GLP-1s without new spending. Only 4.4% of the newly eligible population. Hard to see how Part D plans cover these drugs and indications without substantial additional spending.

Now up at Health Affairs Forefront, Kristi Martin and I analyze the published explanations for the 2027 cycle of the Medicare drug price negotiation program. We focus on what's in (and what's not in) the explanations, as well as implications for future cycles. www.healthaffairs.org/content/fore...

Excited to see this piece with @michaelannica.bsky.social and @rachelsachs.bsky.social out We looked at the Rural Health Transformation Program: Its funding formula had a clear small-state bias; we ask whether its scoring methodology also perhaps favored red states academic.oup.com/healthaffair...

Glad to see STAT highlight the issue of delaying overseas launches, including linking to the public comments @rgfrank.bsky.social, Kristi Martin, and I submitted to CMS on the international reference pricing models. www.statnews.com/2026/03/24/t... www.brookings.edu/articles/com...

The TrumpRx website says, prominently, "Find the world's lowest prices on prescription drugs." And then: "TrumpRx is rewriting the script, bringing major savings on essential medications for all Americans." That's difficult to square with Klomp's remarks. 1/3 www.statnews.com/2026/03/19/c...

"[W]ith some drugs, Mr. Trump appears to have modestly narrowed the gap between European and U.S. prices. But the gap persists, and the reality does not match his hyperbole." www.nytimes.com/2026/03/18/w...

New @jama.com commentary by @rachelsachs.bsky.social @dusetzinas.bsky.social &myself on biosimilar drug competition and price declines. jamanetwork.com/journals/jam...

BREAKING: Vinay Prasad is leaving the FDA for the second time. First reported by the WSJ www.statnews.com/2026/03/06/f...

This RAND report puts the RHTP's inability to offset upcoming Medicaid cuts in grim perspective www.rand.org/pubs/researc...

President Trump didn't mention at all in his SOTU the most significant changes to health care he and Republicans in Congress have engineered: the biggest Medicaid cuts ever, expiration of enhanced ACA premium subsidies, and scaling back recommended vaccines.

Excited that my latest article, Regulating Healthcare Technologies in a Post-FDA World, is forthcoming in the Northwestern University Law Review. I contextualize recent events w/in the theories underlying FDA & FDA's institutional position in the regulatory ecosystem. papers.ssrn.com/sol3/papers....

In light of "the Trump administration’s dismantling of the longstanding federal support for vaccines," "'[t]here will be less invention, investment and innovation in vaccines generally, across all the companies,' Dr. Stephen Hoge, the president of Moderna, said..." www.nytimes.com/2026/02/16/h...

From Alec Gaffney at @agencyiq.bsky.social: "There doesn’t seem to be a coherent approach to evidentiary requirements at the FDA at this time, other than one that demonizes vaccines."

Excited to see @mcarrier.bsky.social and my essay about PBMs' creation of private-label biosimilars, their competitive effects, and the potential antitrust issues involved now published in the Yale Journal of Health Policy, Law, and Ethics. yaleconnect.yale.edu/get_file?pid... 1/2

Honored to be testifying before the Health Subcommittee of the House Committee on Energy & Commerce today to discuss the role of the prescription drug supply chain in drug affordability. My testimony is linked below. energycommerce.house.gov/events/healt...

Now up at Health Affairs Forefront, Kristi Martin and I analyze the drugs selected for the 2028 cycle of the Medicare drug price negotiation program. We focus on what will be new this cycle, but also what didn't (but could have) happened this year. www.healthaffairs.org/content/fore...

Great article on FL's inability to import lower-priced drugs. As Commissioner Califf notes, this was known. As just one example, FDA's 2019 preliminary regulatory impact assessment flagged this issue. 1/2

Join us on February 17, 11-12pm ET as @rachelsachs.bsky.social, @profgenkanter.bsky.social, Chris Meekins, and I discuss "FDA and Its Changing Relationship to Industry" This event is for Health Affairs Insiders only - but if you'd like to attend, let me know! www.healthaffairs.org/do/10.1377/h...

So much going on right now but for those of you who care about FDA, @pzettler.bsky.social, @stevejoffe.bsky.social, @rachelsachs.bsky.social, @reshmagar.bsky.social + I have a 2 part commentary in @healthaffairs.bsky.social Forefront on the new plausible mechanism pathway. Link to Part 1 below.

THANK YOU to the hundreds of attendees across the country who tuned in to our virtual seminar today featuring experts @avik.bsky.social, @rachelsachs.bsky.social, @martawosinska.bsky.social, and LDI Executive Director @rachelwerner.bsky.social 📹 Video recap drops next week! https://bit.ly/497G5rE

All four of AbbVie's drugs named in this article already have generic or biosimilar competitors, which is unlikely to change the perception that these deals are relatively weak. www.cnn.com/2026/01/12/p...

Note that this would number would *include* people who were auto-renewed but declined to pay their January premium. The full fallout from nonpayment will play out over months, but the earliest we'd have any data on nonpayment-related attrition — because of the three-month grace period — is April.

Glad to have the opportunity to join @nejm.org for a new podcast about this article with @dusetzinas.bsky.social. It's especially timely in light of the newly released BALANCE model, which aims to instantiate the agreements reached with GLP-1 manufacturers. podcasts.apple.com/us/podcast/n...

Great piece on the impact of the Trump Administration's drug pricing deals and their potential longer-term consequences for industry. www.statnews.com/2026/01/07/j...

Now up at Health Affairs Forefront, my look back at five significant prescription drug policy issues of 2025 (including IRA implementation, FDA turmoil, drug pricing deals, and the 340B program) and a look ahead to five areas to watch in 2026. www.healthaffairs.org/content/fore...

Next Up: ▶️ Drug Pricing in Trump 2.0: Where Are We and What’s Ahead? 🗓️ January 16, 2026 @ 12pm ET Featuring experts @avik.bsky.social, @rachelsachs.bsky.social, @martawosinska.bsky.social, and LDI Executive Director @rachelwerner.bsky.social. Register today: ldi.upenn.edu/events/drug-...

And here's the government's position on insurance coverage: "The shift to recommending one dose could lead to insurers eventually not covering a second HPV dose, an HHS spokesman said." www.washingtonpost.com/health/2026/...

I was very sad to learn of the passing of David Mitchell, a cancer patient who turned his own battle into a fight to make medicines more affordable. Here, @pharmalot.bsky.social gets at why Mitchell was so special. www.statnews.com/2026/01/05/d...

One reason the insurance coverage issue matters is it may possibly impact the ability to challenge these changes in court. A patient who newly has to pay out of pocket for a vaccine (or a dose of one) would seemingly experience a financial harm that's traceable to these changes. 1/2

Although some previously recommended vaccines moved to shared decision-making, it looks like at least the 2nd dose of HPV may have been removed entirely. Would appreciate hearing from experts about the effects of dose deletion on coverage, as CMS is saying there will be no coverage consequences.

This is a policy choice. As Dr. Gottlieb recently put the issue on CNBC: if we substantially reduce vaccination rates, "we're going to have to build new pediatric hospitals." www.youtube.com/watch?v=e8CJ...

For those continuing to monitor the interaction between the various drug pricing models, as Kristi and I note in our Health Affairs piece, CMS has a new update to the GENEROUS manufacturer RFA which raises additional concerns about this question. 1/4 www.cms.gov/priorities/i...

Flagging for drug pricing law & policy people who may have missed it - the 340B rebate pilot program (scheduled to go into effect this week) was enjoined yesterday by a district court judge on procedural grounds. storage.courtlistener.com/recap/gov.us... 1/2

This article notes several choices CMS made that benefit or penalize states on rural health $ based on unrelated legal/institutional structures. Whether the legislature is in/out of session, whether policy change can be made by a governor or requires legislation, etc can be worth millions.

Oncologists should support - not oppose - Medicare drug price negotiation. Lower drug prices benefit patients; this should supersede revenue concerns. So @dusetzinas.bsky.social @rachelsachs.bsky.social and I argue today in @jamaoncology.com jamanetwork.com/journals/jam... 1/

Now up at Health Affairs Forefront, Kristi Martin and I analyze CMMI's newly released proposals for international reference pricing in Medicare (GLOBE and GUARD), including the way they may interact with other important federal programs. www.healthaffairs.org/content/fore...

Drug pricing watchers: CMMI has now announced its model to expand GLP-1 coverage in Part D/Medicaid. I may have more analysis later, but for now a couple of thoughts. www.cms.gov/priorities/i... 1/4

For all drug pricing/federal register followers, the proposed Medicare drug pricing models are out. Looking forward to reading and analyzing.

As an example of these dynamics, if the administration is concerned about the perception that these deals are unlikely to be meaningful, I don't know if it is helpful to center at the press conference the price reduction for brand-name Plavix, a drug which has had generic competition since 2012.

"'When you saw the lack of impact to earnings of the initial companies’ deals, for most coming after, it’s a no-brainer,' said Chris Meekins." Despite the perception that these deals are weak, the administration continues to choose to keep key details confidential, which is unlikely to help.

"One agency source said at least one division is having to pour all of its resources into reviewing drugs that received a voucher, taking time away from other medical products."

Summarizing the current state of pricing and coverage for GLP1s in the US with @rachelsachs.bsky.social in @nejm.org this week! Read it before things change (again)! www.nejm.org/doi/full/10....

Now up at Health Affairs Forefront, Kristi Martin and I identify important aspects of the 2027 Medicare drug price negotiation cycle, including its interactions with other IRA drug pricing reforms. www.healthaffairs.org/content/fore...