Regulatory bodies

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

HHS Secretary Robet F. Kennedy Jr. and FDA Commissioner Marty Makary to announce planned changes as “a major step forward” as part of Kennedy’s “Make America Healthy Again” campaign President Trump has adopted for his administration.

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Mark Meador most recently worked as a visiting fellow at conservative think tank Heritage Foundation’s Tech Policy Center and worked during Trump’s first term as a trial attorney in the Department of Justice’s Antitrust Division. The two Democrat-appointee seats remain open while the members Trump recently fired contest his controversial decision.

Industry should be more vocal about the harms the recent reduction-in-force will have on getting drugs to market, NTEU Chapter 282 President Anthony Lee said in an interview with Pink Sheet.

Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.

FDA introduced the option because it didn’t have sufficient staff to handle the volume of GRAS submission reviews requested by food and other firms for ingredients. Requiring submissions for all GRAS determinations “would just be an unworkable situation for the food industry if somehow submitting notice, submitting notices for FDA review and concurrence, was required,” says food and drug attorney Federick Stearns.

Instead of arguing FDA’s not authorized to offer option under authority from 1958 Food Additives Amendments, potential litigation could contend the law requires agency to continue making self-GRAS without notification available.

HHS Secretary Kennedy ‘s opposition to allowing GRAS without notifications has support but also questions just as strong about whether FDA is authorized to conduct a rulemaking to eliminate the option.

Reps. Latta, Crenshaw and Miller-Meeks contend language in ACNU final rule preamble would allow a sponsor of an approved application to litigate to halt Rx availability of same formulation and “risk eliminating the very rule on which its product approval was based.”