Michael McCaughan

Michael McCaughan

Founder, Prevision Policy

Washington, DC

Michael McCaughan is a founding member of Prevision Policy LLC, a leading provider of regulatory and reimbursement policy analysis for the biopharma industry. He was previously the Editor-In-Chief of The Pink Sheet and remains a contributor to the publication.

Latest from Michael McCaughan

Don’t Ask, Don’t Tell: Senate Democrats Ready To Embrace Makary Heading US FDA

US FDA Commissioner nominee Martin Makary appears set for an easy confirmation after Senate Democrats declined to press him on past inflammatory statements about the agency.

Compounding US FDA’s Problems: The High Stakes In GLP-1 Shortage Actions

The explosion in pharmacy compounding as a source of GLP-1 weight loss medications has put the FDA in a tough spot to defend its drug shortage policies, but it is not the first time that compounding has posed a potentially significant threat to agency authorities.

CAR-T Warning Refinements Coming Soon From US FDA

The US FDA is expected to refine warnings recently added to CAR-T cell therapies about the risk of secondary malignancies after reassuring new data, which is a positive sign for the future of the therapies in autoimmune disorders.

Turning Back The Clock At The US FDA

HHS Secretary Robert F. Kennedy Jr. is nostalgic for the 1960s. Will that include pushing the agency back to the pre-user-fee-era model of defining success based on blocking unsafe drugs, rather than accelerating access to effective ones?

DOGE-ing US FDA: Three Scenarios For What Comes Next

The US FDA has navigated one round of layoff notices, but more cuts could be coming. Here are three potential scenarios.

The Kennedy Era At HHS Begins … With Two Vaccine Approvals

With timing that is purely coincidental, but supremely ironic, the US FDA approved two new vaccines on 14 February, the second day of HHS Secretary Robert F. Kennedy Jr.’s tenure on the job.