As the systematic dismantling of the U.S. vaccine schedule escalates, the demands to hold Health and Human Services Secretary Robert Kennedy accountable are growing. Claiming that Kennedy has turned his back on science and is endangering public health, Rep. Haley Stevens, D-Mich., formally introduced articles of impeachment against him Dec. 10 for “high crimes and misdemeanors.” Under the Constitution, federal officials can only be impeached for treason, bribery and “other high crimes and misdemeanors.”

The U.S. FDA’s remote regulatory assessment (RRA) program, the subject of a guidance the agency finalized in June 2025, is proving to be one of the trickier bits of navigation for makers of devices, drugs and biologics.

After a more than 13-year period of stability with Janet Woodcock as the head of CDER, with Patrizia Cavazzoni taking charge during the next four years of former U.S. President Joe Biden’s tenure, the FDA division has had no fewer than five different people in charge throughout 2025. Up to bat now as acting director is Tracy Beth Høeg, a physician and epidemiologist who co-authored a paper in 2022 with CBER Director Vinay Prasad, FDA Commissioner Marty Makary and others demonstrating that COVID-19 boosters and college vaccine mandates were harmful to young men due to myocarditis risks.

Individual liberty and choice vs. wider public health became one predictable hinge upon which swung the often-acerbic debates at the CDC’s Advisory Committee for Immunization Practices (ACIP) meeting, which took up – again – the matter of hepatitis B virus (HBV) vaccine scheduling, a day after the panel voted not to vote on such guidance.

Disorganization resulting from last-minute changes to voting questions involving new recommendations for hepatitis B virus vaccines created a moment of déjà vu Dec. 4 when the CDC’s Advisory Committee for Immunization Practices (ACIP) voted 6-3 to once again delay its votes on whether the current recommended birth dose should be pushed back.

On Dec. 2, 2025, the FDA released draft guidance that could reduce the use of nonhuman primates (NHPs) in preclinical testing of monoclonal antibodies. According to the guidance, which the FDA released for the purpose of soliciting comments, “In general, studies longer than 3 months in nonrodent species (e.g., NHPs, dogs, and mini-pigs) are not warranted to evaluate toxicities … when data from 3-month studies are supplemented with a weight-of-evidence (WoE) risk assessment.”

“Do not take us backwards,” many doctors and other stakeholders implored the CDC’s Advisory Committee for Immunization Practices ahead of its meeting that starts Dec. 4 with a day-long discussion and votes on whether the current recommended birth dose of the hepatitis B virus vaccine should be delayed.