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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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Learning To Love The “CFL”: US FDA’s New Communication Policy

Final guidance on communication “consistent with the label” is noteworthy for how closely it follows Obama-era draft. That may be a surprising twist given the background of the Trump-era FDA Commissioner and HHS Secretary – but on balance is probably the best possible approach for maintaining the current FDA approval climate.
Advertising, Marketing & Sales Legal Issues

Pacira’s Exparel Will Get Separate Medicare Payment; CMS Still Wants Better Opioid-Sparing Data

US Centers for Medicare and Medicaid Services proposes a change to its reimbursement policies for non-opioid pain therapies which will benefit a single product: Pacira’s Exparel. However, the broader message for that company is mixed.

Reimbursement Medicare

Pointing Fingers On Biosimilars: FDA Versus FTC

US FDA is talking tough on antitrust enforcement. But is there any reason to think FTC is listening?
Biosimilars Legal Issues

Part B Reform: HHS Proposal Is Intriguing – But Bigger Message Is Timing

“Immediate” actions on drug pricing reform aren’t necessarily happening soon, given that the competitive bidding proposal is just a request for information.
Pricing Debate Reimbursement

Importation To Address Drug Pricing? Just Do It – But Don’t Justify It

The idea of permitting importation of competitors to products like Daraprim has an undeniable appeal, and – unlike essentially every other idea on the table to deal with drug pricing – would actually address the singular example that helped kick off the current debate. But creating a legal framework to justify the action is very perilous for the industry overall. 
Pricing Debate Policy

GSK Wins First-Ever Voucher Race With Anti-Malarial Approval

US FDA’s approval of tafenoquine for malaria settled a first-of-its-kind race: GSK beat 60 Degrees to market to claim a priority review voucher.
Review Pathway Rare Diseases
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