One interesting development is that several of these tech startups (and others in the staffing space) have funding from health systems and their VC arms, in addition to funding from more traditional generalist or health-specific VC firms.

Thrilled to see these updates to Circular A-4: whitehouse.gov/omb/briefing-r…. There are so many excellent revisions I cannot capture them all here, but a short thread on some important changes 1/10

Many people are wondering whether pharma will get involved in the appeal of the Texas decision. Rachel Sachs & I wrote abt what is at stake for their industry a few weeks ago for the The Washington Post. washingtonpost.com/opinions/2023/…

What strikes me, for now: this is not an opinion crafted to limit its effect on FDA & pharmaceutical innovation more broadly.

This should worry everyone, as me, Eli Adashi & I. Glenn Cohen discussed: nejm.org/doi/full/10.10…

Greer Donley & Rachel Sachs discussed: washingtonpost.com/opinions/2023/…

“If [Judge Kacsmaryk’s] ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.” whitehouse.gov/briefing-room/…

Follow David, Greer Donley, Patti Zettler, Ameet Sarpatwari, and other FDA law profs for more on this ruling. By his own admission, Judge Kacsmaryk is second-guessing a decision FDA made over 20 years ago. He would permit judicial reevaluation of even decades-old FDA approvals.

Thread, from FDA. As Sue Sutter has written, the existence of generic versions of Makena (approved in 2011) informed the agency's decision to issue a formal withdrawal order, rather than permit Makena's mfr to withdraw voluntarily.

Excited to see my latest article, The Accidental Innovation Policymakers, in print in the Duke Law Journal! I analyze key legislative developments in innovation policy (both health & IP) and explore implications for the legislative process and innovation. scholarship.law.duke.edu/dlj/vol72/iss7…

Really thrilled to work with the wonderful editors at Harvard JOLT on our article (with Arti Rai and Nicholson Price (@[email protected])) on the interaction of patent reform and the Inflation Reduction Act! papers.ssrn.com/sol3/papers.cf…

This The New York Times story on Judge O'Connor's decision misses a key point. The decision only applies to PSTF guidelines issued *after 2010*.

Mammographies for women 50-74 were covered with a 'B' rating in 2009, so no one's going to lose coverage for them. uspreventiveservicestaskforce.org/uspstf/recomme…

'O’Connor... has found the ACA to be unconstitutional, either in whole or in part, at least four times now, leaving the appellate courts to clean up his many messes.'

The SG's brief clarifies the stakes of the case, noting that the Federal Circuit's opinion 'invites gamesmanship by brand-name manufacturers' and 'threatens significant harm to competition and to consumers.'

It's worth noting that despite the amicus briefs filed by medical societies and patient groups warning of the potential harms to patients if Judge O'Connor were to issue a broad injunction, Judge O'Connor's opinion today makes zero mention of the effect his ruling will have.

What does Judge O’Connor’s decision mean when it comes to access to preventive services? UM V-BID Center and I have the answers for you: healthaffairs.org/content/forefr…

To the long list of law+policy wrongs in Braidwood opinion, add:

🤫It stares in #ERISA preemption as deregulatory agenda's silent partner.

An opinion striking federal health insurance law boosts deregulatory effects because states *can't* fully fill the void it leaves.👇1/2

Fifteen states have policies to protect no-copay preventive services if the ACA provision is nullified. commonwealthfund.org/blog/2022/aca-…

But those state protections don't—can't—extend to self-insured employer plans (which is to say, most private insurance)

Context: the ACA requires health plans to cover highly effective preventive services with no copays because they have public health benefits & there’s a strong public interest in not letting copays deter people from getting preventive care.

As expected, Judge O'Connor has struck down the Affordable Care Act's preventive services mandate. His decision applies nationwide. Reviewing the decision now; will highlight key portions as I read. /1 storage.courtlistener.com/recap/gov.usco…