Joined October 2016
- Tweets 53
- Following 394
- Followers 116
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Pinned Tweet
28 Apr 2022
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" papers.ssrn.com/sol3/papers.…
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1 Nov 2023
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
link.springer.com/article/10…
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Joseph Daval retweeted
23 Oct 2023
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.
23 Oct 2023
My op-ed today in @washingtonpost with @akesselheim on the Medicare drug lawsuits: washingtonpost.com/opinions/…
Their arguments rely on the untenable premise that for-profit companies have a constitutionally protected right to receive taxpayer dollars.
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23 Oct 2023
My op-ed today in @washingtonpost with @akesselheim on the Medicare drug lawsuits: washingtonpost.com/opinions/…
Their arguments rely on the untenable premise that for-profit companies have a constitutionally protected right to receive taxpayer dollars.
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Joseph Daval retweeted
27 Sep 2023
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" jamanetwork.com/journals/jam…
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🔥 🔥 🔥 @JAMA_current viewpoint by @DavalJoseph @LiamBendicksen @akesselheim.
Protecting Medicare’s Discretion to Say No to Unproven Therapies
jamanetwork.com/journals/jam…
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8 Sep 2023
My latest in JAMA with @LiamBendicksen and @akesselheim from @PORTAL_Research:
Protecting Medicare’s Discretion to Say No to Unproven Therapies
jamanetwork.com/journals/jam…
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8 Sep 2023
"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."
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Joseph Daval retweeted
8 Aug 2023
We had our annual @PORTAL_Research retreat yesterday! Always inspired by this group.
Looking forward to the year ahead in pharmaceutical policy!
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28 Jul 2023
New papers!
Today in @JAMAInternalMed with @akesselheim @PORTAL_Research:
Can Medicare limit coverage of FDA-approved products? Yes, and it does.
jamanetwork.com/journals/jam…
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28 Jul 2023
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.
jamanetwork.com/journals/jam…
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Joseph Daval retweeted
7 Jul 2023
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 @akesselheim
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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
ALT "When the FDA acts to regulate medical products, it can no longer assume that a reasonable interpretation of the law will be upheld in court." Perspective C. Joseph Ross Daval, J.D., Liam Bendicksen, B.A., and Aaron S. Kesselheim, M.D., J.D., M.P.H.
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Joseph Daval retweeted
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
ALT "When the FDA acts to regulate medical products, it can no longer assume that a reasonable interpretation of the law will be upheld in court." Perspective C. Joseph Ross Daval, J.D., Liam Bendicksen, B.A., and Aaron S. Kesselheim, M.D., J.D., M.P.H.
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13 Mar 2023
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"
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13 Mar 2023
With amazing co-authors @LiamBendicksen and @akesselheim
nejm.org/doi/full/10.1056/NE…
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Joseph Daval retweeted
20 Dec 2022
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: businessofgovernment.org/blo…
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20 Sep 2022
Excellent commentary by @JakeElberg on our new @PORTAL_Research paper, both in @JAMAInternalMed
Great insight on DOJ's approach to enforcement in the health care industry—well worth a read!
20 Sep 2022
I appreciated the opportunity to discuss issues raised by this significant new analysis from @DavalJoseph, @akesselheim, and Jerry Avorn re: DOJ's use (or lack of use) of the Park doctrine to prosecute company executives @JAMAInternalMed @JAMANetwork jamanetwork.com/journals/jam…
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Joseph Daval retweeted
20 Sep 2022
New from @DavalJoseph in @JAMAInternalMed - 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/jam…
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