Rachel Sachs

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....

Vaccine Makers Curtail Research and Cut Jobs

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."

It's a timely topic of interest to policymakers - the private-label biosimilar topic, in addition to other PBM behaviors that have been in the news, came up at Wednesday's E&C hearing on the role of the prescription drug supply chain in affordability. 2/2 bsky.app/profile/rach...

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

www.wsj.com/health/healt...

Health Subcommittee: Lowering Health Care Costs for All Americans: An Examination of the Prescription Drug Supply Chain The Committee on Energy and Commerce is the oldest standing legislative committee in the U.S. House of Representatives and is vested with the broadest jurisdiction of any congressional authorizing com...

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...

I wrote about these issues relating to the final rule in 2020. If it's too difficult to import lower-priced drugs at scale, one option is to import the lower prices paid abroad - leading to the current administration's international reference pricing push. 2/2 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.

Drug Pricing in Trump 2.0: Where are We and What's Ahead? This panel will bring together experts to explore the evidence for whether the Trump administration's initiatives are likely to deliver meaningful relief for consumers and to discuss what to expect from drug pricing policy under the current administration.

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

The Great Healthcare Plan calls for codifying the Trump Administration’s Most-Favored-Nation deals to get Americans the same low prices for prescription drugs that people in other countries pay. This would build off President Trump’s landmark actions that made insulin more affordable in his first term and the successful voluntary negotiations following his recent Executive Order to lower drug prices. Voluntarily negotiated deals with HHS/CMS will be grandfathered in.

www.whitehouse.gov/fact-sheets/...

Trump administration strikes deal with AbbVie to cut costs of certain drugs | CNN Politics The Trump administration has finalized a deal with drugmaker AbbVie to cut the cost of certain medicines, marking the latest pact as part of its “Most Favored Nation” pricing initiative.

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...

And in the eyes of the market, pharma doesn’t appear to have given up much of value in the negotiation, despite Trump’s promise that certain drug prices would come down by “over 1,000%.” The actual details of each agreement are known only to the government and the drugmakers themselves, but the major pricing concessions apply to Medicaid, which already gets steep discounts, and to patients paying cash for certain drugs, a small fraction of the overall market. Moreover, public companies are required by law to publicize material changes to their business. Not one drugmaker has made such a disclosure to the Securities and Exchange Commission, a lack of smoke suggesting there’s no fire, said Spencer Perlman, managing partner at Veda Partners.

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...

Health Affairs Journal

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...

Drug Pricing in Trump 2.0: Where are We and What’s Ahead? This panel will bring together experts to explore the evidence for whether the Trump administration’s initiatives are likely to deliver meaningful relief for consumers and to discuss what to expect fr...

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/...

With political savvy and outrage over drug prices, advocate David Mitchell was ahead of his time David Mitchell, who helped launch Patients for Affordable Drugs to raise awareness of high drug prices and seek to bring them down, died at age 75.

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...

Memorandum in Support of Motion – #145 in American Academy of Pediatrics v. Kennedy (D. Mass., 1:25-cv-11916) – CourtListener.com MEMORANDUM in Support re 144 MOTION to Dismiss for Lack of Jurisdiction MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM filed by Centers for Disease Control and Prevention, Robert F. Kennedy, Jr, Unite...

Using the AAP v. Kennedy case as a comparator, the government is arguing both that ACIP votes moot similar types of challenges and also that plaintiffs there lack standing. Here, there hasn't (yet) been an ACIP vote, though presumably that could change. 2/2 storage.courtlistener.com/recap/gov.us...

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...