Rx Drugs

FDA drug center director Janet Woodcock, who last May joined the Trump administration’s Operation Warp Speed initiative and recused herself from FDA’s COVID-19 product review decisions, will take on a new role at FDA -- principal medical adviser to FDA chief Stephen Hahn.

FDA announced late Monday evening (Jan. 4) that changing the doses for authorized COVID-19 vaccines is not backed by scientific evidence and could pose health risks despite recent suggestions by a top Operation Warp Speed official that some of the vaccines could be safely administered in half-doses.

The drug and device industries are pushing back against FDA’s plans to finalize a rule this month that will amend the definition of “intended use,” alleging the rule would violate the First and Fifth Amendments.

Specialty drugs spending is on the rise, but the use of biosimilars could help lower overall costs, according to the Pharmaceuticals Strategy Group’s year-end report on drug costs.

As other countries start planning human challenge trials to study and speed development of COVID-19 vaccines, debate continues in the United States over whether the controversial trial approach, in which participants are infected with the live virus, is ethical or necessary.

Medicare seems to have figured out how to make coronavirus antibody therapies free for everyone in Medicare after initially struggling to determine how to make the administration of antibody therapies free for Part B beneficiaries who lack supplemental coverage.

The Trump administration managed to buy another 100 million doses of Pfizer’s coronavirus vaccine for about $2 billion after turning down the extra 100 million doses this summer, and as recently as this November, and finding itself in a bind because other countries bought those doses in the interim.

The U.S. government and Moderna are considering conducting dose sparing trials of the company’s COVID-19 vaccine to see if it could be just as effective at doses lower than the 100 micrograms for which it’s currently indicated, Operation Warp Speed chief Moncef Slaoui said during a press call Tuesday (Dec. 21).

Drug makers are largely unscathed by the year-end government spending bill because Congress instead used hospital surprise billing legislation to pay for coronavirus relief, but the legislative package does include proposals that were part of drug price transparency bills, including one to give congressional Medicare and Medicaid advisers data on closely guarded rebates.