Senator Cruz’s RESULT Act Contains a Particular View of the FDA’s Role – But What About CMS?

By Rachel Sachs

Last week, I blogged here about the introduction of the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act (text) by Senators Ted Cruz and Mike Lee. As I noted, the Act would require the FDA to speed review of drugs, devices, and biologics that are already approved for marketing in a particular list of countries, including EU member countries, Japan, and Canada. If the FDA declines to grant reciprocal marketing approval, the Act would permit Congress to override the FDA’s decision through a majority vote via a joint resolution.

My post, and additional commentary from numerous other outlets (including RAPS, Vox, and Marginal Revolution) largely focused on the Act itself – on the merits of the various provisions, and on whether those provisions would be effective at accomplishing the Act’s stated goals. But each commentator’s view of the situation depends in large part on their priors about what the purpose of the FDA is, and relatedly, how it should behave to achieve those purposes. In this post, I want to first briefly explain these different views about the purpose of the FDA before explaining the ways in which our views about pharmaceutical regulators are often tied to our views about public health insurers – a point which has largely gone unmentioned in the debate about the RESULT Act.

Continue reading

“Naughty or Nice?’ A Special ‘The Week in Health Law’ Podcast Review of the Year in Health Law & Policy

By Nicolas Terry

twihl 14x14

In a special Holiday-themed show reviewing the year in Health Law & Policy Nic welcomed Nicole Huberfeld, the Ashland-Spears Distinguished Research Professor of Law at the University of Kentucky College of Law, Nicholas Bagley, Professor of Law at the University of Michigan, and honorary ‘Nic’ Elizabeth Weeks Leonard, J. Alton Hosch Professor of Law at the University of Georgia.

The ‘naughty or nice’ round included discussion of the declining numbers of the uninsuredKing v. BurwellArmstrong v. Exceptional Child CenterGobeille v. Liberty Mutual Insurance CompanyChief Justice RobertsSenator Marco Rubio, and FTC cases LabMDPOM WonderfulWyndham & North Carolina Board of Dental Examiners.

Our ‘Happy New Year’ round included the House of Representatives ACA lawsuitUniversal Health Services v. United States ex rel. Escobar, the MMA 2003 non-interference clausehealth care prices, and Whole Woman’s Health v. Cole.

Finally, our ‘carolers-of-choice’ were Justice ScaliaDonald TrumpJimmy Fallon and the FLOTUS with the MOSTEST.

We’ll be back in the New Year. Happy Holidays. Thanks for your support Dear Listeners!

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw