Michael McCaughan

Contributor at Scrip

Founding Member, Prevision Policy LLC Business Implications of FDA and CMS Policy; Policy Implications of Biopharma Business

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Articles

US FDA Meeting Drought Ends … With A Vengeance

1 week ago | insights.citeline.com | Michael McCaughan

US FDA Meeting Drought Ends … With A Vengeance The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly. Is a flood of FDA public meetings upcoming now that the apparent freeze has ended? (Shutterstock)
US FDA’s Familiar Drug Pricing To-Do List

1 week ago | insights.citeline.com | Michael McCaughan

US FDA’s Familiar Drug Pricing To-Do List President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace. A provision in a Trump executive order on drug pricing looking to limit anti-competitive behavior seems largely benign. (Shutterstock)
US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

2 weeks ago | insights.citeline.com | Michael McCaughan

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It SeemsUS FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea. Martin Makary and Robert Califf support COVID-19 vaccine placebo-controlled trials. (Shutterstock)
US FDA Advisory Committee Misperceptions Abound … At HHS

1 month ago | insights.citeline.com | Michael McCaughan

US FDA Advisory Committee Misperceptions Abound … At HHS HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs. Eliminating industry representatives on advisory committees may be a small price to settle HHS Secretary Robert F.
Makary’s Reorganization Decision A Turning Point For US FDA?

1 month ago | insights.citeline.com | Michael McCaughan

Makary’s Reorganization Decision A Turning Point For US FDA? US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.
What MAHA Means For US FDA: Prevention Is Not What You Think

1 month ago | insights.citeline.com | Michael McCaughan

What MAHA Means For US FDA: Prevention Is Not What You Think US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution. MAHA wants new FDA approval pathways for treatments addressing the root cause of chronic diseases. (Shutterstock)
Makary’s Reorganization Decision A Turning Point For US FDA?

1 month ago | insights.citeline.com | Michael McCaughan

Makary’s Reorganization Decision A Turning Point For US FDA? US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse. Without a major reorganization to worry about, FDA staff may be able to adjust to the new normal. (Shutterstock)
Political Influence And The US FDA: A New Era?

1 month ago | insights.citeline.com | Michael McCaughan

Political Influence And The US FDA: A New Era? FDA Commissioner Martin Makary declared during an interview with former Fox News host Megyn Kelly that there “should be nothing political” about the US FDA, but it feels like politics is infecting the agency in unprecedented ways about three weeks into his tenure. Politics continues to creep into FDA actions despite Commissioner Martin Makary's declaration that the agency should be apolitical. (Shutterstock)
Political Influence And The US FDA: A New Era?

1 month ago | insights.citeline.com | Michael McCaughan

Political Influence And The US FDA: A New Era? FDA Commissioner Martin Makary declared during an interview with former Fox News host Megyn Kelly that there “should be nothing political” about the US FDA, but it feels like politics is infecting the agency in unprecedented ways about three weeks into his tenure. Politics continues to creep into FDA actions despite Commissioner Martin Makary's declaration that the agency should be apolitical. (Shutterstock)
US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

1 month ago | insights.citeline.com | Michael McCaughan

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals. FDA's Office of Generic Drugs understands the importance of hitting the mark on user fee goal dates. (Shutterstock)