Any future FDA Commissioner will have to face eroding trust in our public health institutions. Accelerated approval accounts for a minority of approvals but encapsulates trends feeding mistrust, making a good starting point to restoring FDA’s credibility. www.healthaffairs.org/content/fore...

New from Institute for Clinical and Economic Review (ICER) and Verdant Research: We revisited our 2021 white paper on FDA's accelerated approval pathway. icer.org/news-insight...

Scoop: Vinay Prasad is out at FDA. HHS spokesperson said "he did not want to be a distraction to the great work of the FDA in the Trump administration." Story TK in Pink Sheet.

🚨 Top 5 Takeaways from our 2024 Biopharma Wrap-Up 🚨 Every 6 months, my team and I review biopharma R&D and investment decisions. Our latest report examines 2024. Much of the last year was shaped by the ongoing race to fill impending revenue gaps as older drugs face LOE. More below 👇

🩺📊 #medsky

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...

I had a chance to join CBS News and Major Garrett to discuss my recent @newyorker.com piece on the consequences of money in medicine. Is U.S. health care entering a "gilded age"?

Is U.S. health care in a "gilded age"?

A New Yorker article argues that we are in "the gilded age of medicine." So what does that mean for U.S. health care? Dr. Dhruv Khullar, associate professor of health and economics at Weill Cornell Me...

cbsnews.com

Vertex $VRTX touts pain drug results, but medicine does not outperform placebo in sciatica study www.statnews.com/2024/12/19/v... via @matthewherper.bsky.social

Vertex touts pain drug results, but medicine does not outperform placebo in sciatica study

A Vertex drug hit its mark in a Phase 2 study in chronic pain, but faces questions about its performance versus placebo.

statnews.com

At @kff.org, we’ve been busy updating our interactive with national health spending data released yesterday. Explore trends in US health care costs from 1960-2023 and make your own charts using this tool: www.healthsystemtracker.org/health-spend...

National Health Spending Explorer - Peterson-KFF Health System Tracker

This interactive tool provides up-to-date information on U.S. health spending by federal and local governments, private companies, and individuals. It was developed by KFF using data from the National...

healthsystemtracker.org

www.nytimes.com/2024/11/22/o...

Opinion | In This House, We’re Angry When Government Fails

The Democratic Party needs to rethink what it means to be the party of institutions.

nytimes.com

Every drug I used when I took care of kids with cancer had serious risks. The only thing that could justify my using them was that their benefits outweighed their risks. But without proof of efficacy, there’s no way to make that calculation. Safety & efficacy are 2 sides of the same coin.

Doctors for America@drsforamerica.bsky.social · 2y ago

HHS Deputy Secretary pick Jim O’Neill, believes the FDA should only consider safety and not efficacy when making approval decisions. Someone should let him know that taking ineffective medical products DOES affect patient safety. thehill.com/homenews/adm...

A costly symptom of our complicated drug reimbursement system: People in the same Medicare drug plan face wildly different prices for the same drug

Medicare Pays Wildly Different Prices for the Same Drug

Middlemen negotiate prescription costs at thousands of different price points, depending on your insurance plan.

wsj.com

We are hiring new fellows and faculty in PORTAL. Please reach out if interested! And spread the word.

Program On Regulation, Therapeutics, And Law (PORTAL)@handle.invalid · 2y ago

📣PORTAL is hiring! 📣 There are less than 2 weeks left to apply for our Postdoctoral and General Medicine Fellowships, both with a focus on pharmaceutical law, health policy, and health services research. Apply by December 1, 2024. Learn more: mailchi.mp/3e02f38a708b/portal-hiring-2025

How to write a scientific paper in four slides. Full guide here: www.surgeryredesign.com/s/WritingFor... YouTube format here: youtu.be/fgeahUrXVaY?... #meded #medsky #research

On the DHHS and CMS news, I will not allow MAHA. I may allow for MWAHA because, sarcasm. Health journalists and academics, say no to the acronym. First act of resistance. ##healthpolicy #youmustbejoking

a cartoon character wearing a hoodie is laughing in front of a fire background .

ALT: a cartoon character wearing a hoodie is laughing in front of a fire background .

media.tenor.com

I already have a headache sorting signal from noise and it‘s not even 2025 yet. Gonna be a while before we have a clear picture of what this means for Rx. www.axios.com/2024/11/19/r...

RFK Jr. vs. Vivek: Trump world's two paths for pharma regulation

Between RFK Jr. and Vivek Ramaswamy, the incoming Trump administration has widely divergent views on regulating the drug industry.

axios.com

"We’ve had members and manufacturers say, OK we will not invest in developing a biosimilar in Medicare Part D or in the PBM space, if the PBM system does not change.” - Juliana Reed of the Biosimilars Forum #healthpolicy

Time To Tip the Scales? Humira Biosimilars And The Limitations Of Competition In US Health Care

<p>In year two, Humira biosimilar uptake – or the lack thereof – continues to build the case for policy reform to incentivize use of cheaper biologics in the outpatient setting. </p>

pink.citeline.com

A big congrats to Biden administration and CMMI on moving forward with a novel payment approach for cell and gene therapies! www.cms.gov/newsroom/pre...

Incentive for R&D is always a topic in Pharma policy, but debate usually focuses on investment and development. I fear the pressure to show novelty at the bench is being overlooked. How much money and effort is going into chasing scientific dead ends? www.statnews.com/2024/01/19/d...

For any docs out there who struggle with prior auth and would love to have your biases confirmed, I highly recommend this new study by @michaelannica.bsky.social and Nancy Keating, out yesterday in JCO: pubmed.ncbi.nlm.nih.gov/38086013/ 1/

NON-profit hospitals — what’s in a name? Check out my @nytimes.com oped asking nonprofit boards to come back to their mission www.nytimes.com/2023/11/30/o... @sangerkatz.bsky.social @dusetzinas.bsky.social @stevejoffe.bsky.social

Opinion | How to Put ‘Community’ Back in the Mission of Community Hospitals

Nonprofit hospitals are behaving in ways that seem to focus more on dollars than patients.

nytimes.com

In a recent Health Affairs Forefront post, National Pharmaceutical Council put forward cherry-picked examples to argue that Medicare negotiation will harm incentives to innovate. The problem: their own examples show the opposite. Here’s our response. @dusetzinas.bsky.social @bnrome.bsky.social

What professional development topics do you wish you learned about in grad school (in a PhD program, in particular)? #healthpolicy

This would be such an long-overdue win for those living with Hepatitis C. www.nytimes.com/2023/11/28/o...

Will be key to keep track of FDA's success in this effort to get needed long-term data on gene therapies. #healthpolicy pink.citeline.com/PS149041/US-...

US FDA Struggling With Long-Term Follow-Up Requirements For Gene Therapies

<p>OTP Director Nicole Verdun acknowledged the agency may need help to determine how to ensure 15 years of patient follow-up is completed despite physician retirements, company closures and other issu...

pink.citeline.com

I think this $NOVO suit may be one of the most interesting to watch in terms of the Medicare negotiation challenges. #healthpolicy

Novo Files Suit Over IRA As It Joins Others In Signing On To Price Negotiations

<p>The nine drug manufacturers with products selected for Medicare drug price negotiations have agreed to participate in the program. Seven of them now have pending suits challenging the Inflation Red...

pink.citeline.com