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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 Advertising: The 'Kick Me' Sign On Big Pharma’s Backs

Treating mandatory wholesale acquisition cost disclosure in TV ads as a major drug pricing reform is close to ludicrous. But the broad approval of the action is an important sign of the continued public image cost of the ads to the drug companies.

 

Pricing Debate Reimbursement

Tired Of Winning? When It Comes To US FDA Appeals, “Denied” Can Still Mean Victory

Success rate for sponsors pursuing appeals of FDA rejections is much higher than reported by agency, a leading US regulatory law firm argues. Agile Therapeutics’ “loss” of an appeal is a good example of how sponsors can still benefit even if their formal request is denied.
Drug Review Regulation

Credibility And Crying Wolf: US FDA Petition Guidance Says Past Practices Can Count Against You

FDA is warning sponsors that a history of generic-delaying tactics may come back to haunt them when the agency considers whether a Citizen Petition is frivolous and potentially anti-competitive. But so will waiting too long to speak up.
Generic Drugs Regulation

Gilead’s Price Reduction Strategy: A Serious Move, But Not A Long-Term Model For US

“Authorized generics” for Gilead's leading hepatitis C brands stands out from prior, largely symbolic responses to the lower list prices. This is not a political move, but a business one. It is also the clearest demonstration yet of why pricing reforms are necessary if lower list prices are the policy goal.
Pricing Debate Infectious Diseases

Opioid Prescribing Guidelines Put US FDA In Unfamiliar Territory

FDA has always described its role as stopping short of regulating the practice of medicine. When it comes to opioids, that is no longer the case. 
Legislation Regulation

Value-Based Drug Reviews? US FDA Guidance Emphasizes “Accountability, Communication & Consistency”

Updated Good Review Management Principles focus exclusively on “fundamental values and operational principles” underpinning the new drug review process – leaving nuts-and-bolts procedures to be spelled out elsewhere.
Drug Review Drug Approval Standards
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