Happy to have the opportunity to hype this huge new piece that happened to hit on this holiday: led by Ben Rome, a viewpoint on issues relating to the emergence (hooray!) of new biosimilar Humira: pubmed.ncbi.nlm.nih.gov/37026489/

Introduction of a citrate-free version of adalimumab in 2018 avoided Medicaid's inflationary rebates and led to >$4B excess spending from 2018-2021. ja.ma/3SP2qlf Charlie ChangWon Lee Aaron Kesselheim Ben Rome Program On Regulation, Therapeutics, And Law

New cross-sectional study finds that more than half of #AcceleratedApproval confirmatory trials are completed after the deadline set by the FDA. Aaron Kesselheim Ben Rome Program On Regulation, Therapeutics, And Law ja.ma/3KndEuB

Important session next week on racial discrimination and pulse oximetry in the Program On Regulation, Therapeutics, And Law and Center for Bioethics health policy and bioethics consortium! Register please!

Despite new penalties via the #InflationReductionAct , drug companies raised prices for nearly 1k drugs in January. Is Congress' attempt to curb drug price hikes failing?

Read the #OpEd by Alexander C. Egilman, Aaron Kesselheim & Ben Rome of Program On Regulation, Therapeutics, And Law.
bit.ly/3lVo9vA

Thanks for a great presentation karim / sariahmed.bsky.social!

Prior authorization requirements for 1/3 of new drugs in Medicare Part D are more restrictive than FDA labeling, according this cross-sectional study. LSE Health Policy Research Portal Aaron Kesselheim Robin Forrest ja.ma/3lK4vCD

Is It Business as Usual for the Drug Industry?

In MedPage Today, Alex Egilman, Aaron Kesselheim, and I explain why drug companies continued to raise prices in 2023 despite the #InflationReductionAct

medpagetoday.com/opinion/second…

Watch Program On Regulation, Therapeutics, And Law Ameet Sarpatwari speak at today's SenateHELP Committee hearing on COVID vaccine pricing -- and check out our The Boston Globe op-ed from Hussain Lalani, MD, MPH, MSc on the public funding critical to its development: bostonglobe.com/2023/03/21/opi…

New entry in the NEJM Fundamentals of Health Law Series! Consolidation and competition in the health care sector -- and implications for patients and pricing; from Jaime King. Collect them all!: nejm.org/doi/full/10.10…

Policy makers have several options to maximize benefits from public investments and improve returns for the entire global community, write Hussain Lalani, MD, MPH, MSc, Sarosh Nagar, Jerry Avorn, and Aaron Kesselheim.
trib.al/TmiXjUb

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

Great article from Zach Brennan
Endpoints News today covering our new work Health Affairs on inhaler patents and litigation.

Where are all the generic inhalers for asthma and COPD? Researchers call for patent and FDA reforms - endpts.com/where-are-all-…

According to new findings, some of the most heavily advertised drugs are often no better at treating a disease than lesser known options hrvd.me/DrugAdvertisin…

Interesting point by Sean Dickson… maybe the new Medicaid rebate rules were one of the factors driving Lilly to lower list prices.

Aaron Kesselheim and I wrote about this in JAMA Internal Medicine back in 2021: jamanetwork.com/journals/jamai…

Next in our NEJM Fundamentals of Health Law series: a focus on fraud/abuse and COI rules with Prof Zack Buck from Univ of Tennessee: nejm.org/doi/pdf/10.105…

Medicare price negotiation under the #InflationReductionAct could reduce prescription drug spending by at least 5% in the first 3 years, according to a simulation study. Ben Rome Program On Regulation, Therapeutics, And Law ja.ma/3XmOkrJ

Yesterday, filed an amicus brief in the Amgen v Sanofi SCOTUS Updates case detailing why undeserved broad drug patents harm patients and innovation, w/ Jerry Avorn, National Center for Health Research, Arnold Ventures, & others. Thanks to the great team at Fish & Richardson: supremecourt.gov/DocketPDF/21/2…