Rachel Sachs
@resachs
Professor of Law, Washington University in St. Louis. Researching and writing about innovation policy, mostly in health law, FDA law, and patent law.
ID: 1263255792
http://law.wustl.edu/faculty_profiles/profiles.aspx?id=10753 13-03-2013 01:13:06
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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…
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…
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…
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…
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.
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.
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/…
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/…