US FDA

Regulators in the US and Canada are working together to streamline approval timelines for generic drugs through a voluntary information sharing program.

Martin Makary’s photo-op and videos promoting the groundbreaking of a new Novartis US-based manufacturing facility create an appearance of favoritism, President George W. Bush’s former chief ethics lawyer told the Pink Sheet.

As differences emerged between FDA staff and senior political leaders over its COVID-19 safety review, CBER Director Vinay Prasad added an old colleague and critic of US COVID-19 policy to the center.

At an expert panel overwhelmingly composed of people favoring expanded testosterone use and loosened safety warnings, career FDA staff suggested new clinical trials would be required to approve some of the changes.

Experts said the impact of the planned approval standard changes are difficult to assess given the potential for flexibility outlined in the JAMA article, as the FDA again eschews guidance and public comment in making new policy.

The move is intended to allow incoming acting director Tracy Beth Høeg to learn from outgoing director Richard Pazdur before he retires.

The tilt toward approval extended beyond patients and advocates to clinicians, professional societies and industry.

Pink Sheet reporter and editors discuss the likely impacts of Center for Drug Evaluation and Research Director Richard Pazdur’s retirement from the FDA and Tracy Beth Høeg becoming the center’s acting director.

At a CDC vaccine advisory committee criticized for “promoting an anti-vaccine agenda,” the new CDER director championed the committee’s plans and suggested the FDA would make more frequent vaccine label updates due to revised safety frameworks.

The soon-to-be former CDER director will return to the oncology office to complete his FDA tenure, the agency said.

In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.

Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.

Flu vaccines are specifically mentioned in the CBER director's internal email, but all new and some older vaccines seem to be affected. The impact on development programs is unclear.

The FDA leadership drama continues after Richard Pazdur was elevated to drug center director. Can Pazdur, CBER Director Vinay Prasad, and Commissioner Martin Makary get along?

In an email to staff filled with unsupported accusations about the quality of the center’s research, CBER Director Vinay Prasad said no resources or time should be spent on ongoing projects started before he joined the FDA until discussed with him.

Merck, Lilly, and Johnson & Johnson are some of the pharma companies who have snagged the many staff leaving the FDA’s oncology positions. The Pink Sheet estimates CDER’s oncology division is operating with about a 20% vacancy rate.

Five of the six winners of the US FDA’s second batch of Commissioner’s National Priority Vouchers are for secondary indications. That is no accident, Commissioner Makary says.

Elevating the Office of Therapeutic Biologics and Biosimilars out of the Office of New Drugs and providing signatory authority could help speed biosimilar reviews, OTBB Director Sarah Yim said.

From how he will interact with industry to his staff, to a possible advisory committee revival and dangling accelerated approval crackdowns, Pink Sheet looks at how Rick Pazdur's oncology track record could translate to CDER.

The appointment of longtime FDA oncology leader Richard Pazdur to lead FDA's Center for Drug Evaluation and Research is being well received.