New from Joseph Daval in JAMA Internal Medicine - the Park doctrine is available to hold corporate officers directly responsible for fraud; why hasn't it been applied to more rx drug/med device cases?: jamanetwork.com/journals/jamai…

Excellent commentary by Jake Elberg on our new Program On Regulation, Therapeutics, And Law paper, both in JAMA Internal Medicine Great insight on DOJ's approach to enforcement in the health care industry—well worth a read!

Pleased to announce a recent small grant from the IBM Center for The Business of Government to support a comprehensive report on FDA Advisory Committee performance and reform led by Program On Regulation, Therapeutics, And Law fellow Joseph Daval coming in 2023: businessofgovernment.org/blog/new-resea…

The FDA has long conducted its oversight of prescription drugs and other products with deference from courts. But mounting judicial skepticism of agency authority threatens to upend this norm. nej.md/3J8jKx0

New Program On Regulation, Therapeutics, And Law perspective out NEJM this week from Joseph Daval @LiamBendicksen Aaron Kesselheim

Consistent alignment with advisory recommendations, along with an overall decrease in meetings, suggests that FDA is leaning away from independent expert advice even as it continues to follow it, according to this quality improvement study. ja.ma/3NGcsmr Aaron Kesselheim

We had our annual Program On Regulation, Therapeutics, And Law retreat yesterday! Always inspired by this group. Looking forward to the year ahead in pharmaceutical policy!

🔥 🔥 🔥 JAMA viewpoint by Joseph Daval Liam Bendicksen Aaron Kesselheim. Protecting Medicare’s Discretion to Say No to Unproven Therapies jamanetwork.com/journals/jama/…

Nice piece Joseph Daval on protecting CMSGov's coverage discretion: "A system in which taxpayers are required to pay for inferior treatments is not a competitive marketplace—it is an entitlement program for for-profit companies subsidized by the public" jamanetwork.com/journals/jama/…

My op-ed today in The Washington Post with Aaron Kesselheim on the Medicare drug lawsuits: washingtonpost.com/opinions/2023/… Their arguments rely on the untenable premise that for-profit companies have a constitutionally protected right to receive taxpayer dollars.

Big Pharma's legal arguments against price negotiation are absurd. Pharmaceutical manufacturers are not entitled to limitless profits at the expense of the American taxpayer. They should not abuse the legal system to stop the IRA's drug price provisions from going into effect.

FDA uses advisory committees for recs on new drug approvals, but how does EMA use its scientific advisory groups? New piece in JGIM Journal of General Internal Medicine from Program On Regulation, Therapeutics, And Law with Ameet Sarpatwari, Leigh Sharpless, and Aaron Kesselheim link.springer.com/article/10.100…