When @US_FDA goes to court, @TheJusticeDept is its lawyer. But how does DOJ control of litigation shape FDA policy? I interviewed 20 former FDA and DOJ attorneys for my Article "Litigating Authority for the FDA" https://t.co/HFlAAePUdl
FDA uses advisory committees for recs on new drug approvals, but how does EMA use its scientific advisory groups?
New piece in @JournalGIM from @PORTAL_Research with @AmeetSarpatwari, @LeighSharpless, and @akesselheim
https://t.co/1IxhXuqz2V
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.
My op-ed today in @washingtonpost with @akesselheim on the Medicare drug lawsuits: https://t.co/axwCsDHEtu
Their arguments rely on the untenable premise that for-profit companies have a constitutionally protected right to receive taxpayer dollars.
Nice piece @DavalJoseph 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" https://t.co/GZohBWTtFa
🔥 🔥 🔥 @JAMA_current viewpoint by @DavalJoseph @LiamBendicksen @akesselheim.
Protecting Medicare’s Discretion to Say No to Unproven Therapies
https://t.co/nHU6B1L2eY
"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."
My latest in JAMA with @LiamBendicksen and @akesselheim from @PORTAL_Research:
Protecting Medicare’s Discretion to Say No to Unproven Therapies
https://t.co/rJbFLMHUuV
And (a few weeks ago) in @JAMAHealthForum with @akesselheim@argMaxRusso & Theodore Teng @PORTAL:
Dramatic decrease in FDA use of drug advisory committees, but FDA continues to follow their recommendations in most cases.
https://t.co/q5fyjwwlZo
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. https://t.co/meelHTpXdz @akesselheim
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. https://t.co/hhYGve4CTz
How will the major questions doctrine affect FDA's authority to protect public health?
Excited to share a new @NEJM Perspective from @PORTAL_Research: "Eroding Judicial Deference to the FDA—Consequences for Public Health"
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 @PORTAL_Research fellow @DavalJoseph coming in 2023: https://t.co/CJ960yt3jI