Elections

Biotech execs and lobbyists try to explain the Trump Administration's policy strategy and how to thrive in it.

Robert F. Kennedy Jr. will become HHS secretary while retaining his anti-vaccine positions. His first action likely will be creating a new safety commission, which industry must hope holds off more drastic action.

At a lively AAM Access! conference in Florida, AAM President and CEO John Murphy acknowledged the negative effects of potential tariffs, but also suggested that the second Trump Administration could be an opportunity for the generics and biosimilars sectors to advance market reforms.

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.

The FDA's recent communications freeze has blocked participation in international standards development groups, which could impact the alignment of US and international requirements.

The Trump transition so far has all the hallmarks of the tech industry’s favorite management slogan, but that might not work well for biopharma companies if the FDA is one of the agencies that gets broken.

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.

The chair of the Senate Health, Education, Labor and Pensions Committee questioned whether Kennedy could reject anti-vaccine views in the face of data affirming their safety and efficacy.

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.

The cell and gene therapy field has reached an inflection point in the US as the second Trump Administration begins and advocates argue the sector could fit well with the “MAHA” agenda.

The White House is expected to name Sara Brenner, chief medical officer for in vitro diagnostics at CDRH and a veteran of the first Trump administration, as acting commissioner, but the lack of a formal announcement is creating uncertainty. New executive orders on telework and the senior executive service also could impact agency staff.

Pink Sheet editors consider ex-FDA officials’ advice for the Trump Administration on implementing FDA reforms, comments CDER Director Patrizia Cavazzoni made before her departure from the agency about wanting to release review documents for applications that received complete response letters, and diverging trends between CDER and CBER novel application approvals.

Robert Califf’s final appearance on Capitol Hill as US FDA commissioner, a 5 December Senate hearing focused on the agency’s food and nutrition functions, was an appropriate coda to his tenure and preview of things to come under the Trump Administration.

Former FDA commissioners Mark McClellan and Scott Gottlieb, former acting commissioner Janet Woodcock and current commissioner Robert Califf offered advice on successfully implementing reforms and preventing a mass exodus of FDA employees as inklings emerge that the Trump team is already engaged on this front.

6 January 2025 will be remembered in Washington, DC, as the date Congress certified Donald Trump’s second presidential election victory and a snowstorm shut down most of the city, but for FDA watchers it will be the day the agency released more than two dozen new draft and final guidances.

Despite GOP criticism of the Part D stabilization program and its budgetary impact, the Trump Administration may decide to keep it in part to avoid blame for a premium increase.

Some pharma industry CEOs appear to have done well in their meeting with President-elect Donald Trump and his health care team.

Former Sen. Richard Burr suggested to the Pink Sheet that Trump’s HHS leadership picks will have less ability to enact their agendas than people expect.

The incoming Trump Administration’s “Department Of Government Efficiency” has big plans for sweeping cuts to the federal bureaucracy and regulation. The US FDA likely will feel some effects, but could avoid the most damaging mandates.