Two weeks in­to his tenure lead­ing the FDA’s bi­o­log­ics cen­ter, Vinay Prasad has made his mark with a new frame­work for ap­prov­ing fu­ture Covid-19 vac­cines that he feels will coun­ter­act ex­ist­ing “dog­ma.”

The epi­demi­ol­o­gist, on­col­o­gist and bio­sta­tis­ti­cian — and long­time agency crit­ic — pre­sent­ed the vac­cine pro­pos­al on Tues­day as part of his first ma­jor ac­tion at the agency, rolling it out in a New Eng­land Jour­nal of Med­i­cine ed­i­to­r­i­al and in a we­b­cast with FDA Com­mis­sion­er Mar­ty Makary.

The new pol­i­cy will nar­row the pop­u­la­tion of peo­ple that can get one of the three ap­proved Covid vac­cines, from every­one 6 months and old­er to peo­ple 65 and old­er, or peo­ple who are 6 months to 64 years old who are at high­er risk of se­vere dis­ease.

Sen­ate De­moc­rats grilled HHS Sec­re­tary Robert F. Kennedy Jr. on Tues­day over gaps in his bud­get and fund­ing cuts that have halt­ed or elim­i­nat­ed key clin­i­cal re­search.

For the most part, Kennedy plead­ed ig­no­rance or de­nied clin­i­cal tri­al cuts.

"We are not cut­ting any tri­als," Kennedy said. "Cor­rup­tion, mis­placed pri­or­i­ties, and in­ten­tion­al­ly lim­it­ed scopes of in­quiry have con­fined re­search for years. We’re chang­ing that. In this ad­min­is­tra­tion, Alzheimer’s, the in­fer­til­i­ty cri­sis, ear­ly on­set pu­ber­ty in girls, low testos­terone in men, and more can fi­nal­ly re­ceive the at­ten­tion they de­serve."

The hear­ing be­fore a Sen­ate Ap­pro­pri­a­tions sub­com­mit­tee comes as Kennedy plans to roll out his Make Amer­i­ca Healthy Again vi­sion for HHS in a new re­port on Thurs­day, which he said will spell out his plan to com­bat what he calls the child­hood chron­ic dis­ease cri­sis.

The De­part­ment of Health and Hu­man Ser­vices pro­vid­ed the first de­tails for how it plans to tie US drug prices to rates paid in sim­i­lar­ly de­vel­oped coun­tries as part of Pres­i­dent Don­ald Trump’s most fa­vored na­tion ex­ec­u­tive or­der.

Un­der the pro­gram that was first an­nounced by Trump last week, the US would tar­get prices based on bench­marks from oth­er wealthy na­tions that have a per capi­ta GDP of at least 60% of the US, ac­cord­ing to a press re­lease Tues­day.

The Trump ad­min­is­tra­tion has said that it wants drug de­vel­op­ers to of­fer those low­er prices to con­sumers to buy di­rect­ly. If they don’t com­ply, the ad­min­is­tra­tion would pur­sue reg­u­la­tion to force the low­er prices. HHS said it ex­pects drug man­u­fac­tur­ers to com­ply with this di­rec­tive for all brand­ed prod­ucts that don’t have gener­ics or biosim­i­lars avail­able.

The FDA's On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee vot­ed 8 to 1 against whether Genen­tech's piv­otal tri­al is ap­plic­a­ble to the US pa­tient pop­u­la­tion for a Columvi la­bel ex­pan­sion.

Genen­tech is seek­ing ap­proval for Columvi (glofi­ta­m­ab) in com­bi­na­tion with gem­c­itabine and ox­ali­platin for the treat­ment of adult pa­tients with re­lapsed or re­frac­to­ry dif­fuse large B cell lym­phoma who are not can­di­dates for au­tol­o­gous stem cell trans­plant. But pan­elists ex­pressed reser­va­tions about the gen­er­al­iz­abil­i­ty of da­ta from the Phase 3 tri­al, which was com­prised of about half of its pa­tients from Asia and in­clud­ed just 25 pa­tients (9%) from the US.

"Even if we pre­tend­ed there's a ben­e­fit in the non-Asian pop­u­la­tion, it's a sig­nif­i­cant­ly small­er ben­e­fit" than in the Asian pop­u­la­tion, said ad­comm pan­elist Daniel Spratt of Case West­ern Re­serve Uni­ver­si­ty, who vot­ed "no" on the gen­er­al­iz­abil­i­ty of the tri­al da­ta.