Regulatory bodies

As many as 700 employees reportedly dismissed from posts starting on 14 February as the culling of the federal workforce by the Trump administration’s Department of Government Efficiency reaches FDA.

President Trump's Executive Order creating the commission names mental health and weight-loss drugs as treatments of concern. But it does not mention vaccines, which Kennedy has criticized.

Trade groups say they welcome working with Robert F. Kennedy Jr. on expanding and improving consumer access to OTC drugs and dietary supplements. White House “Department of Government Efficiency Workforce Optimization Initiative” limits filling federal agency vacancies.

Restrictions on commonly used chemicals, increased reporting requirements and enhanced environmental risk assessments are just some of the new EU sustainability and environmental rules pharmaceutical companies are potentially facing. While some measures are multi-sectoral, others are pharma specific. The Pink Sheet takes a look at some of the developments in 2024 and expectations for 2025 and beyond.

During Trump’s second administration and with Republican majorities currently in both chambers of Congress, FDA may find even less support than it traditionally has for appeals for additional resources to improve compliance with the NDIN requirement. Likewise for FDA request mandatory product listing requirement for supplements available to US consumers.

“We've heard perhaps some kind of support for non-drug approaches to addressing a range of conditions,” says food and drug regulation attorney Jessica O’Connell. “For the first time in the nearly 80 years of HHS, we will have a secretary who actually sees our commodity is valuable and not just some nuisance they have to deal with,” says NPA CEO Daneil Fabricant.

New details are emerging about how the administration will implement some of President Trump’s workforce shift back to mostly in-office work.

Avandra CEO says the company has created the world’s largest federated network for de-identified imaging data, providing researchers access to medical images that will accelerate the advancement of clinical trials, precision medicine and AI applications.

The FDA's interim leadership takes shape, but the sense of transition chaos still lingers.

Supplies from Mexico and Canada could become even more important to US firms as well as more reliable than their current systems, says Rob Handfield, Bank of America distinguished professor of supply chain management at NC State.