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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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Building A Wall? The Plan To End “March In” Threat To US Drug Patents

Calls to exercise “march in” rights on federal patents licensed to pharmaceutical companies are a recurring theme in the US drug pricing debate. Now the Department of Commerce is proposing to make those threats even emptier than they already are.
Pricing Debate Innovation

US FDA’s Slow Start To Approvals In 2019: Don’t Panic

US FDA approved just six new molecular entities in the first quarter of 2019, which seems like quite a letdown after a record-setting year in 2018. But don’t despair: the pattern of NME approvals was back-loaded a year ago – and should be again this year.

Approvals FDA

Filling The Rebate Void: PBMs Versus Wholesalers

The proposal to eliminate rebates in the US raises important follow up questions, including who will be responsible for pharmacy transactions at the point of sale. PBMs say they should stay in that role to assure a smooth transition; independent pharmacies have other ideas.

Reimbursement Pharmacy Benefit Management

PBMs On Capitol Hill: Why Pharma Will Miss Them When They Are Gone

Drug pricing “middlemen” had their day in the hot seat during a Senate Finance Committee hearing on drug pricing. But even amid the finger-pointing between industry and PBMs over the high cost of drugs, the PBM execs offered some strong reminders of their real value to industry in fending off more overt price interventions by government.  
Pharmacy Benefit Management Pricing Debate

The Return Of The “Specialty” Drug Pricing Debate In The US

Pharma has been almost wholly successful in shifting the ground in the US drug pricing debate away from high-cost “specialty” products and towards the large gap between list and net prices, with the most intense focus on older medicines like insulin. What happens when the debate shifts back?
Pricing Debate Reimbursement

“B” Best? Handicapping The Democratic Field For Pharma

Drug pricing is bound to be a dominant theme in the 2020 Democratic primaries and US Presidential election. But there are some differences in the crowded field of candidates, including several who are more likely to emphasis protecting innovation alongside controlling prices.  
Elections Pricing Debate
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