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NOVEMBER 15: join us for 'Improving Im/migrant Health Care Access: Moving In the Right Direction?' with Program On Regulation, Therapeutics, And Law and Petrie-Flom Center. 🩺 Register here: lp.constantcontactpages.com/ev/reg/ysrb833

Just out NEJM, Joseph Daval Aaron Kesselheim & I discuss strategies to reduce already-delayed confirmatory trials for accelerated approval drugs. In particular we ask: should the FDA use fines to encourage timely trial completion? nejm.org.acs.hcn.com.au/doi/full/10.10… #medtwitter

New piece out led by Jelle Stoelinga examining supplemental indications on oncology drugs in the US vs EU. ejcancer.com/article/S0959-…

Despite the Pediatric Research Equity Act, which applied to only 30% of new drugs approved 2015-2021, >50% of required postmarketing pediatric trials remain incomplete after 5.5 years, highlighting the impact of rare disease exemptions. ja.ma/4gO3xgF

In order to ensure timely testing of drugs that have been granted accelerated approval, the FDA can impose civil monetary penalties on dilatory manufacturers — but has never done so. Read the full Perspective: nej.md/3BvjsAe

The federal government has proven that it can navigate the difficult process of identifying drugs for price negotiation, gathering and analyzing key information, and negotiating with manufacturers. Read the full Perspective: nej.md/48711hx

Interested in the strategies and tools clinicians can use to help their patients afford prescription drugs? Check out this new overview in @JAMA by Hussain Lalani, MD, MPH, MSc, Catherine Hwang, Ben Rome, and Aaron Kesselheim highlighting the options available to patients.

💊 New study in JAMA provides clear steps busy clinicians & staff can take to help patients struggling to afford their prescription drugs! We include an algorithm based on the patient's health insurance status & drug type (brand vs. generic). READ: jamanetwork.com/journals/jama/…

Presenting some work on QALY-based cost-effectiveness analyses at #SMDM24 that shows some arguments against the use of QALYs have little empirical justification. Program On Regulation, Therapeutics, And Law

Published today in JAMA Oncology with Aaron Kesselheim and Program On Regulation, Therapeutics, And Law team. We discuss the case of cancer drug Xtandi whose early stage developments were heavily funded by government grants and public funds but now is priced more in the U.S. than in other high-income countries.

I'm excited to share a new study out today The BMJ comparing the two single-inhaler triple therapies on the US market. Brief thread below! bmj.com/content/387/bm…

Tune in TODAY at 10am ET as PORTAL Director Aaron Kesselheim testifies before the House Ways & Means Health Subcommittee: youtu.be/x_rhGT9AM0k He'll be discussing threats to US biomedical research, the need to protect and expand Medicare drug price negotiation, and more.

Happening now: Ways and Means Committee hearing on lowering costs for patients: The health of the biosimilar market featuring Program On Regulation, Therapeutics, And Law’s Aaron Kesselheim.  Watch here: bit.ly/3YqiXzV

Excited to get this brand new book by Jerry Avorn from Program On Regulation, Therapeutics, And Law in the mail today! Can't wait to give it a read! Brigham and Women's Hospital Harvard Medical School