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Michael McCaughan

Michael McCaughan has has 25 years of experience providing analysis and insight about the biopharma industry, including 10 years as Editor-In-Chief of The Pink Sheet and The Pink Sheet DAILY. He speaks frequently on regulatory and policy developments affecting the industry.
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Latest From Michael McCaughan

FDA User Fee Bills: Is It Possible For Reauthorization To Be Too Clean?

First draft of user fee omnibus bill is about as 'clean' as a bill can be – free of the policy riders that have always been attached to US FDA funding legislation in past cycles. That is good news for industry, which is eager to see the program reauthorized with as little drama as possible, but could the bill actually be too clean?

Pricing Debate Legislation

Times Have Changed: FDA Ends ESA REMS Ahead Of First Biosimilars

FDA is ending one of the landmark drug safety programs from the REMS era, announcing it has released Amgen from its mandatory obligations for the erythropoiesis-stimulating agent (ESA) class. The decision comes just ahead of the likely approval of the first biosimilar application in the class.

Drug Safety Biosimilars

CMS Solicits Ideas To Improve Part D: An Opening For Co-Pay Reform And Shaping Priorities

The US Medicare agency signals interest in making administrative changes to the Part D drug insurance program in the coming years. That may be an opening for the pharmaceutical industry to push for new approaches to cost-sharing – but it is also an opportunity for plans to try to shape the evolution of Part D in the Trump administration.

Medicare Regulation

Trump Has Won On Drug Prices – According To Breitbart

The pharmaceutical industry is always struggling to get good press when it comes to drug prices. But a recent headline in Breitbart News is one to savor – as long as the President believes it.

Pricing Debate Policy

PhRMA And Trump: 'Go Boldly,' Or Tread Carefully?

Brand name industry’s image campaign promises to 'Go Boldly' – but there has been nothing bold about its public response to the Trump Administration’s efforts to repeal the Affordable Care Act, the President’s strong words on drug pricing, or even proposed cuts to NIH funding and FDA. Treading carefully makes a lot of sense – but is there a line that PhRMA won’t let the Administration cross?

Pricing Debate Legislation

The Politics Of Opana: US FDA’s Opioid Problems Won’t Go Away

A two-day safety review of Endo’s reformulated Opana ER provided strong support for FDA’s view that products using abuse-deterrent technology cannot simply be assumed to be 'safer' than conventional formulations. However, there are also no easy answers for when and how FDA will be able to move out of the hot seat on opioid abuse.

Advisory Committees FDA
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