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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

Big Pharma CEOs Get Ready To Testify: Preparing For A No-Win Situation

Here is what to expect from – and some free advice for – seven industry executives as they prepare for a hearing on drug pricing in the Senate Finance Committee.
Pricing Debate Legislation

Rebates, Discounts, And Antitrust: HHS Thinks Law Is On Its Side

One concern raised ahead of HHS proposal to eliminate the “Safe Harbor” permitting prescription drug rebates is that the alternative – up-front discounts – may run afoul of antitrust law. HHS, however, is advising stakeholders to review the law more carefully.
Reimbursement Pricing Debate

HHS Rebate Rule: At Least We Know Who Is In Charge

HHS proposal to eliminate the “safe harbor” that allows for prescription drug rebates took a long time to clear White House review. Its release sends a clear message that US HHS Secretary Azar wants to lead the drug pricing debate in 2019.

Medicare Pricing Debate

US FDA's Shutdown Offers One Possible Winner

For most sponsors, shutdown's impact won’t be too dramatic – but for two peanut allergy companies, the stoppage had very different implications. 
Drug Review Drug Approval Standards

US FDA’s REMS Reluctance On Display At Recent Advisory Committees

Drug safety focused meetings would once have been almost certain to focus on mandatory risk management plans as a solution. But FDA not only didn’t propose that approach, it actively discouraged its advisors from considering it.
Drug Safety Risk Management

Democratic Oversight And Trump’s Rx Price Blueprint: Three Possible Routes

House Democrats and the Trump Administration share an interest in taking on high drug prices. They probably won’t cooperate – but will the House actively block administrative changes?
Pricing Debate Legislation
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