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 Advisory Committee Misperceptions Abound … At HHS

1 week 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 week 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 week 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 week 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?

2 weeks 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?

3 weeks 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

3 weeks 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)
US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

3 weeks 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. The FDA's Office of Generic Drugs understands the importance of hitting user fee goal dates. (Shutterstock)
US FDA Center Directors Are Political Now

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

US FDA Center Directors Are Political Now The forced departure of CBER Director Peter Marks is a milestone event for the agency, as center directors now are likely to be treated as political positions subject to change with each new administration. New administrations or FDA commissioners now could expect center directors to leave their posts. (Shutterstock)
US FDA Under Makary: MAHA With A Lighter Touch

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

US FDA Under Makary: MAHA With A Lighter TouchUS FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency. FDA Commissioner nominee Martin Makary could be confirmed by the Senate in the coming days. (Screenshot of Senate Broadcast)