Peter J. Pitts

A patient nearly lost her life after taking compounded version of a GLP-1 drug. Not bought online. Not from the street but prescribed and dispensed by a compounded pharmacy. This must-read Washington Post op-ed is a stark reminder of a parallel drug market hiding in plain sight, out of control and threatening lives. Today we’re seeing large-scale production of copycat versions of complex medicines without FDA pre-market review, without verified quality standards, and often with ingredients sourced through opaque global supply chains. That’s not personalization. That’s a workaround and a prescription for disaster. The FDA has been clear: it cannot verify the safety, quality, or effectiveness of unapproved mass compounded drugs. And yet these products are being aggressively marketed with a wink and a nod as if they are interchangeable with FDA-approved therapies. “Essentially a copy?” – give me a break. And for shame on the pharmacies that peddle these mistruths, half-truths and outright lies. washingtonpost.com/opinions/2026/…

I was honored to be consulted for this important new GAO study. Net/Net --FDA Adcomms don't need to be phased out -- they need to be improved. lnkd.in/e7-8E2aG

“The secretary can do a number of things. For example, he could go back and reinstate every member of every CDC committee who are more or less very pro-vaccine and still do what he wants to do,” Pitts said, noting that while the panel endorses recommendations, the director of the CDC and Kennedy are under no obligation to adopt them. msn.com/en-us/health/o…

RFK Jr.’s Attack on Vaccines Will Backfire in Georgia realclearhealth.com/2026/03/23/rfk…

Why ERISA Needs a Pharmacy Benefit Overhaul realclearhealth.com/2026/03/18/why…

Per the RFK, Jr. court ruling --don't pop those champagne courts quite so fast. The legal case is a mechanistic — not scientific one. It will be litigated and I'd rather not rely on procedural issues that can be addressed by HHS attorneys. But a W is a W. #ModernDayMonkeyTrial npr.org/2026/03/16/nx-…

If you don't think that medical device cybersecurity has nothing to do right-to-repair legislation -- think again (and think hard). wsj.com/politics/natio…

Direct-to-Patient (DTP) mustn't morph into Disintermediate-the-Physician (DTP).

Mass compounding highlights the consequences of putting profit ahead of patients. When companies rush untested or insufficiently evaluated products to market, they are prioritizing speed and revenue over the rigorous evidence needed to ensure safety and effectiveness. Read more about the findings and what they may mean for policymakers, clinicians, and patients @ tinyurl.com/yzxkf33m

"Adverse event reporting should not be a crowdsourcing proposition." raps.org/news-and-artic…

Remodeling Grief: The Most Crucial Dimension realclearhealth.com/articles/2026/…

A (polite) Tar Heel Tirade -- ncpoliticalnews.com/news/north-car…

"FDA's most important recall of the year." -- Peter Pitts insidehealthpolicy.com/share/154013

Lots of news today.

When it comes to non-profit, hospitals and "community benefit" reporting -- detail matters. thebanner.com/community/publ…

STAT reports on some judicial wisdom ... A U.S. judge ruled that a Tennessee law prohibiting pharmaceutical companies from imposing limits on pharmacies participating in the federal 340B Drug Discount Program does not violate federal law or the U.S. Constitution. Six years ago, many drugmakers began limiting some discounts when hospitals or clinics that participate in the program bought medicines and then shipped them to contracted pharmacies for patients to pick up or for delivery, instead of using their own in-house pharmacies. The drug companies claim that using contract pharmacies led to abuses, such as duplicate billings, product diversions, and ineligible rebates. Numerous states subsequently adopted laws to block drug companies from restricting hospitals from using contract pharmacies. Drugmakers, in turn, filed lawsuits to thwart the laws but have lost many of those cases.