Former FDA Associate Commissioner. President @DrugWonks. Visiting Professor. Champion for smart policy, radical transparency & patient access. #FDA#DrugPolicy
The issue is no longer whether regulatory modernization is necessary. That debate has largely been settled. The issue now is whether review culture and operational decision-making will evolve quickly enough to keep pace with scientific reality. https://t.co/URI36rP7g2
At a tough time for the company, Manifold said he sought to set an example by eschewing the usual privileges of his high office, forgoing a chauffeur-driven car, private jet and tickets for sports events. “I made my own coffee,” he said.
Grounds for dismissal?
In 2002, I spoke at an ALS event in DC. After my talk, a patient said to me, "I'll be dead in a year. Please help make a cure possible." I promised that I would. And I intend to keep that promise. https://t.co/R0o5UkbYdB
“A lack of agency predictability gave industry permission to itself be unpredictable,” said Peter Pitts, a former associate commissioner at the FDA during President George W. Bush’s administration, who is
now the president of the Center for Medicine in the Public Interest. “When the agency threw out
process, developers said, ‘Fine, we’ll throw out process too, and we’ll see who wins.'” https://t.co/05iGXMUTs5
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.
https://t.co/0mbhogb7RM
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. https://t.co/cauFAz3ARG
“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. https://t.co/F7aoOw0Mb6