@PeterPitts

Former FDA Associate Commissioner. President @DrugWonks. Visiting Professor. Champion for smart policy, radical transparency & patient access. #FDA #DrugPolicy

 NYC
cmpi.org
Joined March 2009
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  • Followers2.7K
104Media
FDA Should Practice the Science It Preaches realclearhealth.com/blog/202…

FDA Should Practice the Science It Preaches

The FDA has plenty of advice for pharmaceutical companies. It publishes guidance documents, establishes scientific expectations, and expects drug developers to explain themselves when they take a diff

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Medicare’s Drug Rule Could Penalize Better Treatments dcjournal.com/medicares-drug…

Medicare’s Drug Rule Could Penalize Better Treatments – DC Journal - InsideSources

A cancer patient has better things to do than spend hours in an infusion chair. A medicine that safely reduces that burden represents progress, even when

dcjournal.com
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Access to the right medical device is critical to quality care. Thank you @RepGregMurphy & @RepSchneider for calling to reevaluate urology and ostomy products in competitive bidding, giving policymakers, providers, and patient advocates time to address care concerns.
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FDA's new Karim sky hook. realclearhealth.com/articles…

Rare Disease Patients Need Better Science, Not More Regulatory Ritual

The FDA has spent years trying to fit rare disease drug development into regulatory models that weren't designed for rare diseases. Its new Framework for Rare Disease Review suggests the agency is fin

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Can I get an "Amen." realclearhealth.com/articles…

The Pandemic Is Never Really Over

America's experience with COVID-19 left us with an odd result. We pulled off something scientifically extraordinary and came out of it with less confidence in many of the institutions responsible for

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Righting 340B. Don't give up the ship! thewellnews.com/opinions/rig…

Righting the 340B Ship: Trust but Verify

The 340B Drug Pricing Program was created for the right reasons. But good intentions aren’t a substitute for good oversight, and after more than three decades, 340B is badly in need of both a reality...

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The COVID-19 trust recession: why the next pandemic will be won – or l… sciencedirect.com/science/ar…
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Some good news out of Atlanta ... realclearhealth.com/articles…

CDC Reorganization: Sound Science Over Pandemic Improvisation

The Centers for Disease Control and Prevention's decision to fold Covid-19 and other respiratory-disease work into its influenza infrastructure is a good idea. If the agency gets the execution right,

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The Uncomfortable Truth About Hospital Price Transparency youtube.com/shorts/nMwzO_Ksx… via @YouTube

The Uncomfortable Truth About Hospital Price Transparency

In a Forefront article, Peter Pitts from the Center for Medicine in...

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The Semaglutide Shortage Is Over and So Is the Excuse realclearhealth.com/articles…

The Semaglutide Shortage Is Over and So Is the Excuse

A drug shortage is a public-health emergency. It is not a corporate growth strategy. That distinction, obvious to almost everyone except the expanding mass-compounding industry, received some welcome

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The Compounding Loophole Has Become a Business Model realclearhealth.com/2026/08/…

The Compounding Loophole Has Become a Business Model

There is an old Washington rule worth remembering: Never let a temporary emergency become a permanent business model. That is precisely what is happening with mass drug compounding. Large-scale compou

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It's great when new ideas get traction. raps.org/resource/experts-di…

Experts discusses need to modernize evidentiary models in rare diseases

Using the US Food and Drug Administration’s (FDA) plausible mechanism framework to allow for greater use of causal inference may help with evidence generation for rare diseases, according to a recent...

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FDA: From product regulator to enterprise steward. publichealth.realclearjourna…

Beyond Reshoring: Building a National Pharmaceutical Resilience Strategy

Drug shortages rarely begin with a single failure. By the time a medicine disappears from hospital shelves, the immediate trigger (a contaminated line, a delayed shipment, a hurricane, or an unexpe...

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A real honor to co-author this article with (among others) Turing Prize winner, Dr. Judea Pearl. Have a look. jci.org/articles/view/211143
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Hospital Price Transparency After Five Years: The Next Challenge Is Incentives, Not Disclosure | Health Affairs healthaffairs.org/content/fo…

Hospital Price Transparency After Five Years: The Next Challenge Is Incentives, Not Disclosure |...

Transparency does not fail because hospitals cannot disclose prices. It fails when public policy asks institutions to behave differently without changing the incentives that shape their behavior.

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The time to act is now. realclearhealth.com/articles…

Who Is Policing the Retatrutide Bootleggers?

In May, I wrote about the emergence of a bootleg market for retatrutide, Eli Lilly’s experimental obesity drug. The problem was already hard to miss. Websites and wellness businesses were sellin

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Adcomms deserve the best and the brightest. realclearhealth.com/articles…

FDA's Toughest Decisions Deserve Its Best Experts

FDA's advisory committee process is one of the agency's greatest institutional strengths. No other major drug regulator conducts scientific advisory meetings as publicly -- or as visibly -- as FDA. Sc

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When the Denominator Disappears realclearhealth.com/articles…

When the Denominator Disappears

The FDA advisory committee's recent vote against Capricor Therapeutics' cell therapy for Duchenne muscular dystrophy looked like a decision about one product. It may ultimately be remembered as somet

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No Fifth Amendment plea from us. Gregory Poland and I have nothing to hide. In The Illusion of Over, we don't dodge the difficult questions surrounding COVID-19, vaccines, public health, regulatory science, or the mistakes that continue to shape public trust. We don't ask readers to agree with every conclusion. We ask them to examine the evidence. No talking points. No spin. No pleading the Fifth. Just facts, context, and an honest conversation about what happened—and what must happen before the next pandemic. The Illusion of Over is now available on Lulu.com and shortly on your favorite eBook sites. #TheIllusionOfOver #GregoryPoland #PublicHealth #RegulatoryScience #COVID19 #MedicalInnovation #HealthcarePolicy lulu.com/shop/peter-pitts-an…

Global Book Printing, Publishing, and Technology Company | Lulu

Lulu is a publishing technology platform for on-demand book printing and global fulfillment, powered by APIs and ecommerce integrations.

lulu.com
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A Diamantas in the rough. realclearhealth.com/2026/07/…

Kyle Diamantas' Vision for a Modern FDA

Every FDA Commissioner inherits unfinished business. Scientific advances continue whether regulators are ready for them or not, and every new Commissioner must decide whether the Agency will merely ke

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