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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

DTC And The Art Of Selling An Establishment Pricing Plan To A Populist President

The most surprising proposal coming out the Rose Garden drug pricing event was a call for disclosure of prices in DTC ads. As a policy idea, it may be a dud – but that doesn’t mean it isn’t a critical element of the plan.

Advertising, Marketing & Sales Pricing Debate

Pharma’s Blame-The-Middleman Strategy Pays Off – For Now

Success of drug industry’s campaign to highlight role of 'middlemen' in the supply chain was never more clear than during President Trump’s Rose Garden drug pricing event. But what happens now that the attention is turned squarely back on manufacturers?

Pricing Debate Pharmacy Benefit Management

US FDA Rethinking Post-Market Safety Function As Part Of New Drug Review 'Modernization'

CDER Deputy Director Cavazzoni is leading the review, further indicating her status as heir-apparent to long-time drug center director Janet Woodcock. 
Drug Review Drug Safety

Opioid Manufacturers Should Prepare For A Tobacco Moment

US Senate Democrats are eager to bring in prescription opioid manufacturer executives for a hearing that would recreate the famous image of tobacco industry CEOs being sworn in by Congress. That moment probably won’t come this year – but may be inevitable before the opioid abuse crisis can be declared over.

Advertising, Marketing & Sales Legislation

Rescinding A Refuse-To-File: A Precedent Of Sorts

US FDA’s decision to rescind refuse-to-file letter for Alkermes’ high-profile depression drug is extremely unusual – but not literally unprecedented. One prior example of rescinding an RTF involves an ANDA.

Drug Review Drug Approval Standards

CMS Wants Broader Use of Abuse-Deterrent Opioids – But Needs Help From Congress

Abuse-deterrent formulations are 'potentially useful tool,' but CMS believe it lacks authority to mandate favorable coverage in Part D plans. House E&C committee has nearly three dozen Medicare & Medicaid proposals under consideration – but none that specifically gives CMS the authority it says it needs.

Legislation Medicare
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