US FDA
The pharmaceutical industry has been quiet on Trump's early federal government overhauls that could harm the drug business, still betting he will help produce better results than Biden.
Stakeholders are waiting for the dust to settle to better understand who was laid off as part of the Trump Administration's cuts at the FDA, the reductions' impact on applications currently under review and broader drug development efforts.
Jim Jones, the head of the FDA's food programs, resigned due to widespread layoffs at the agency imposed by the Trump administration’s Department of Government Efficiency.
Experts worry new restrictions on remote work, plans to eliminate certain employees’ job protections and workforce cuts will make the FDA a less attractive employer and hurt pharma’s efforts to get innovative medicines to patients.
Biotech execs and lobbyists try to explain the Trump Administration's policy strategy and how to thrive in it.
A federal judge granted Doctors for America’s motion for a temporary restraining order directing the FDA and CDC to restore information removed from the agencies’ websites to comply with a presidential executive order targeting “gender ideology extremism.”
HHS communications restrictions are keeping the FDA from publicly scheduling expected advisory committee meetings. The lack of upcoming meetings is raising concern about missed user fee dates or lower-quality agency decision-making.
Trump’s former FDA commissioner sees ‘nothing good’ coming from negotiating a new user fee agreement in the ‘current political environment.’
Pink Sheet reporter and editors discuss what pushed a crucial Senate Finance Committee swing vote to support Robert F. Kennedy Jr. as HHS Secretary and the FDA slowly expanding its communications with the public amid the Trump Administration freeze.
There has been “a lot of fear and anxiety” resulting from the Trump Administration’s early actions aimed at freezing grants and FDA communications, NORD’s Pamela Gavin says.
The US Health and Human Services Secretary nominee’s commitment should be a positive sign for those who want to ensure Americans can access adequate data on drugs in all populations that could use them.
As the US FDA determines what media inquiries it can respond to, HHS is deciding whether planned actions or meetings can move forward, depending on whether they are deemed mission-critical.
CDER and CBER once again posted net employee gains, even during the quarter that included the presidential election, despite fears that many would leave rather than endure the changes to be imposed by President Trump.
Pink Sheet reporter and editors discuss Sara Brenner’s introduction as acting FDA commissioner, Robert F. Kennedy Jr.’s confirmation hearings, the Trump Administration’s plans to end telework, and postponed meetings and other issues related to the communications freeze and travel ban.
Sara Brenner’s introductory memo to staff is generally bland but uses HHS Secretary nominee Robert F. Kennedy Jr.’s “Make American Healthy Again!” slogan, which may rile employees and other stakeholders.
Sara Brenner has been a key figure in the FDA’s diagnostics team, but her choice as acting FDA commissioner likely has more to do with her background with advanced technology and comfort level with the tech-focused side of the Trump transition team.
New details are emerging about how the administration will implement some of President Trump’s workforce shift back to mostly in-office work.
A Trump Administration communications freeze and travel ban may be complicating efforts to convene FDA advisory committees. A 5 February meeting on postmarketing requirements for extended-release/long-acting opioids was postponed, while a 24 February meeting on a Novartis rare disease drug was cancelled.
The FDA's interim leadership takes shape, but the sense of transition chaos still lingers.
Pink Sheet reporter and editors discuss the uncertainty created by the Trump Administration freezing most communications at the Health and Human Services Department, new travel and telework bans, as well as the delay in announcing an acting FDA leader and the impact of new executive orders on the FDA and CMS.