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
The threat of Chinese dominance in the prescription drug sector appears to be a strong, unifying theme for legislators heading into the US Food and Drug Administration user fee reauthorization cycle, but two very different sets of policy issues must be addressed.
The expansion of the US Medicare drug price negotiation to include Part B products for the first time should be a very big deal, but the impact is not going to be significant in the first year and maybe future years.
CMS is proposing enhanced payments for hospitals that commit to purchasing essential medicines from domestic sources, but wants ideas for defining a “domestic” medicine.
US FDA’s vaccine advisors will meet in March to make flu strain selection recommendations, but the context for the meeting makes a “routine” event feel extraordinary.
While defending the FDA’s decision-making on rare disease therapies, along with Director Vinay Prasad, US FDA Commissioner Martin Makary talked about review issues in ways commissioners usually do not.
US FDA Commissioner Martin Makary’s first podcast in three months focused on the agency’s Rare Disease Day activities, but, as usual, covered a wide range of issues. A lot has happened since the last episode in November.