With the problematic national priority review voucher in the news again today (FDA staff not involved in decisionmaking? Really?), here’s our overview of how it opens the FDA up to corruption and moves us further and further away from “gold standard” reviews: www.statnews.com/2025/11/21/f...

What he said

I filed an amicus brief on behalf of 24 professors challenging the interim PTO director's illegal policy of blocking IPRs for any patent that is more than a few years old. drive.google.com/file/d/1NhrG...

Reprint of my Substack with @ylepidemiologist.bsky.social today in @statnews.com. Check it out if you’re interested in recent “moves” the FDA is making on drug ads. As with most claims this admin makes … IBIWISI: www.statnews.com/2025/09/13/p...

Another fun collaboration with @ylepidemiologist.bsky.social in Substack with a post on DTC drug ads and the new administration announcement claiming to seek greater enforcement: yourlocalepidemiologist.substack.com/p/pharmaceut...

CBER bein’ like

High brand-name drug prices fall once a generic enters the market. In a new @journalgim.bsky.social article, Ravi Gupta, CRRIT Co-Director @jsross119.bsky.social, and colleagues from @portalresearch.org assess associations between patents, revenue, and generic competition.

Superman. See it.

New @healthaffairs.bsky.social Forefront covering the recent EOs on drug prices and tariffs -- little good news for prices or access -- www.healthaffairs.org/content/fore...

New PORTAL Post from @portalresearch.org for June. Sign up to receive these directly to your inbox! mailchi.mp/eb7d1808132b...

Unrecorded manipulation of large datasets has been common in the US government since Trump's election -- bad for science, trust, and transparency -- in @thelancet.com from Janet Freilich and myself: www.thelancet.com/journals/lan...

Language is now back in the Senate version of the OBBA that would undermine Medicare price negotiation for drugs with Orphan Drug Act designation. Here's our HA Forefront published yesterday (!) from Helen Mooney and @benro.me on why it is a very bad idea: www.healthaffairs.org/do/10.1377/f...

New in @jama.com, Joseph Daval and I discuss legal issues surrounding ACIP including its role in setting government policy and dealing with politically-motivated agendas arising from its new membership: jamanetwork.com/journals/jam...

Thanks to the 2024 peer reviewers for @jlme-journal.bsky.social, with a list here: www.cambridge.org/core/journal...

I helped Your Local Epidemiologist answer some of her pressing Substack subscriber questions on drug prices. yourlocalepidemiologist.substack.com/p/your-top-1...

New Health Affairs Forefront post on the Medicare negotiation "biologic bonus" and the massive financial hit to patients and the health care system of delaying small molecule negotiation from 9 to 13 years, led by Chris Cai and @benro.me: www.healthaffairs.org/content/fore...

New op-ed with @drjoshs.bsky.social and Peter Lurie about the agenda-driven reality of 'radical transparency' -- www.washingtonpost.com/opinions/202...

Interesting new op-ed! Very proud of Max: thehill.com/opinion/5180...

Analysis from former @portalresearch.org fellow Catherine Hwang and @benro.me showing the extent of out-of-pocket costs associated with starting brand-name Entresto over ACEI/ARB for heart failure and implications for overall spending: jamanetwork.com/journals/jam...

New in @nejm.org from Peter Ubel, Astrid Grouls and myself on "financial toxicity" and how to consider it in the context of new drugs @portalresearch.org: www.nejm.org/doi/abs/10.1...

Survey of clozapine prescribers shows satisfaction with the REMS but desire for more educational info, led by @asarpatwari.bsky.social & team at @portalresearch.org in collab with FDA, where world class scientists are sadly being censored and forced out of their jobs: jamanetwork.com/journals/jam...

Interesting use of modeling to predict the timing of patent challenges seeking generic drug entry in PLoS Medicine, led by Ally Memedovich and @portalresearch.org faculty affiliate Reed Beall at Univ Calgary - journals.plos.org/plosmedicine...

Feels v strange to post a paper this week, but @akapczynski.bsky.social, Trudel Pare, Sahil Agrawal, and I wrote a legal roadmap to help states win (and defend) public pharma initiatives. We've sent it out, so law review folks- check your inboxes! #lawsky papers.ssrn.com/sol3/papers....

Check out the February edition of the PORTAL Post, featuring analysis on: - the promise and risk of drug repurposing, - drug importation to address shortages, - use of subgroup analysis in cost-effectiveness studies - biosimilar patent litigation, - and much more! #medsky #healthpolicy

Criticism of the QALY includes the idea that it'll be used to limit drug access to patient subgroups, but @araymakers.bsky.social shows in J Cancer Policy that no evidence of QALYs in cancer drugs being used to do that -- from @portalresearch.org: www.sciencedirect.com/science/arti...

Use of Doxepin for insomnia -- example of potentially useful drug repurposing that seems to be under-prescribed among patients who could benefit because of a problematically high pricing point -- from Chris Cai and @benro.me at @portalresearch.org: jamanetwork.com/journals/jam...

New in @jlme-journal.bsky.social from co-first authors Liam Bendicksen and Mirre Scholte as well as others at @repo4eu.bsky.social, a review of results from research and roundtables on regulatory pathways for drug repurposing in the US & EU: www.cambridge.org/core/journal...

New piece led by Anushka Bhaskar @portalresearch.org in STAT First Opinion on protecting public health agencies from damaging political interference -- even the threat of which can greatly affect people's behavior: www.statnews.com/2025/01/31/p...

From Rosa Ahn-Horst @portalresearch.org -- psychiatric drug innovation over the last decade shows widespread use of clinical endpoints but few new mechanisms of action and 3/16 drugs for which < half the trials submitted to FDA were positive (in JAMA Network Open): jamanetwork.com/journals/jam...

Dark times for science. Proud of my colleagues at JLME for speaking up: www.statnews.com/pharmalot/20...

Due to the Trump administration freeze on communication from government agencies, an article JLME planned to publish this spring on research misconduct has been placed on hold. Read more: www.statnews.com/pharmalot/20...

Also out this week a review of new EU pharma policies and their potential impact on repurposed drugs with the excellent Mirre Scholte and Manuela Joore who are collaborating with @portalresearch.org on the REPO4EU project: pubmed.ncbi.nlm.nih.gov/39756647/

In @nejm.org this week led by @tombollyky.bsky.social with Sarosh Nagar of @portalresearch.org and Chloe Searchinger - how a rational regulatory approach to supporting importation of generic drugs can be used to respond to essential medicine shortages: www.nejm.org/doi/full/10....

Congrats to former @portalresearch.org fellow Hussain Lalani for having one of the most-read articles in JAMA Health Forum in 2024: read.alerts.jamanetwork.com/csb/Public/s...

Dry powder inhaler shows similar effectiveness and safety to metered-dose inhaler, w numerous implications including that environmentally-friendly prescribing in this case is also clinically equivalent -- led by @wbfeldman.bsky.social of @portalresearch.org in BMJ: www.bmj.com/content/387/...

The case of cancer drug Xtandi - Bishal Gyawali @akesselheim.bsky.social @jama.com oncodaily.com/science/bish... #Cancer #CancerPolicy #JAMAOncology #OncoDaily #Oncology #Xtandi

Comments for great CNN health reporter Meg Tirrell on new independent generic liraglutide @portalresearch.org: www.cnn.com/2024/12/23/h...

Let's get it passed (next yr)!: @portalresearch.org led by Alex Egilman, @benro.me, and Bryan Walsh cited as basis for bipartisan Skinny Labels, Big Savings Act (www.hickenlooper.senate.gov/wp-content/u...) from Sens Hickenlooper, Cotton, Welch, Collins: www.hickenlooper.senate.gov/wp-content/u...

New survey data led by Sanket Dhruva and Rita Redberg in collab with @portalresearch.org asks physicians how they talk with patients about regulatory info related to new drugs and high-risk medical devices (use of surrogate measures, post-approval req'ts, etc.): journals.sagepub.com/doi/10.1177/...

Fun pharma policy jokes in this week’s SNL monologue! New audience for @portalresearch.org pubs?

Pre-holiday PPV: Fed Circuit in Teva v Amneal follows recommendation in amicus brief written by @wbfeldman.bsky.social and Sean Tu of @portalresearch.org, affirming delisting of improper inhaler patents from OB and helping promote timely generic competition: fedcircuitblog.com/wp-content/u...

Enzalutamide for prostate cancer got millions in public funding but remains exceedingly expensive for US patients. New in JAMA Onc from Bishal Gyawali, former @portalresearch.org fellow and current assoc prof at Queens Univ, as well as Emily Jung and Helen Mooney: jamanetwork.com/journals/jam...

New in JAMA HF from @portalresearch.org's @benro.me and Anushka Bhaskar: tracking use and spending on adalimumab in the first year after biosimilars shows low biosimilar uptake but substantial reductions in overall spending: jamanetwork.com/journals/jam...

Welcome to Blue Sky, @jlme-journal.bsky.social! Please follow if you want to get alerts about new articles and columns published in the oldest peer-reviewed journal at the intersection of law, medicine and ethics. (And to participate in the annual "Where in the World is JLME?" competition.)

The wrong ways and right ways to reform the FDA in the new administration - new in Health Affairs Forefront from me and Josh Sharfstein: www.healthaffairs.org/content/fore...

The Journal of Law, Medicine & Ethics (Cambridge University Press) is seeking qualified candidates to apply for openings on its Board of Editors -- see the description of the journal and the BoE role here: www.cambridge.org/core/journal...

Financial toxicity in cancer meds: @portalresearch.org's collaborator @eddiecliff.bsky.social and others review the potential financial implications of receiving vorasidenib for glioma and how different countries manage the high cost: academic.oup.com/nop/advance-...

Check out important new Viewpoint from @portalresearch.org collaborators @eddiecliff.bsky.social and Kerstin Vokinger on regulatory oversight of AI-enabled medical devices in JAMA Neurology: jamanetwork.com/journals/jam...

Complex new study in American Heart Journal from former @portalresearch.org fellow Catherine Hwang and PORTAL faculty @benro.me about primary adherence to ARNIs vs ACEI/ARBs. Bottom line: no difference but longer to fill for the more expensive ARNIs: tinyurl.com/395bjdvr