The FDA is seek­ing feed­back ahead of a pub­lic meet­ing this sum­mer to eval­u­ate the progress of a vouch­er pi­lot that has so far ac­cel­er­at­ed four drug ap­provals.

Cre­at­ed last June, the Com­mis­sion­er's Na­tion­al Pri­or­i­ty Vouch­er pi­lot looks to shave months off of new drug and bi­o­log­ic re­views if they align with sev­er­al strate­gic pri­or­i­ties, such as meet­ing un­met med­ical needs or in­creas­ing af­ford­abil­i­ty through pric­ing. The agency last Ju­ly said it sought to award up to five vouch­ers, but to date, the agency has award­ed 18 vouch­ers and grant­ed four ap­provals.

On Fri­day, the FDA an­nounced a pub­lic hear­ing on the pi­lot for June 12. The agency said in a Fed­er­al Reg­is­ter no­tice that it wants in­put on el­i­gi­bil­i­ty cri­te­ria, the vouch­er se­lec­tion process, spon­sor re­spon­si­bil­i­ties, FDA re­view pro­ce­dures and pro­gram im­ple­men­ta­tion.

A group of biotech in­vestors will meet with mem­bers of a con­gres­sion­al com­mis­sion that's been charged with keep­ing the US com­pet­i­tive in biotech and pro­tect­ing na­tion­al se­cu­ri­ty, amid the rise of Chi­na's own life sci­ences in­dus­try and shift­ing pric­ing dy­nam­ics around the globe.

Known as the Na­tion­al Se­cu­ri­ty Com­mis­sion on Emerg­ing Biotech­nol­o­gy (NSCEB), the group was es­tab­lished in 2021, and has been hold­ing ses­sions with biotech stake­hold­ers, as well as hold­ing lis­ten­ing events around the US. On Tues­day, it will meet with at least sev­en biotech in­vestors, in­clud­ing rep­re­sen­ta­tives from JP Mor­gan, Pfiz­er, and sev­er­al oth­er ven­ture cap­i­tal firms, End­points News has learned.

Ac­cord­ing to an agen­da and at­tendee list re­viewed by End­points, the group will dis­cuss the com­mis­sion’s pri­or­i­ties, the im­pacts of the Trump ad­min­is­tra­tion’s push to low­er drug prices, FDA un­cer­tain­ty and IP pro­tec­tions.

The lead drug pric­ing ne­go­tia­tor at the White House said the over­ar­ch­ing goal of TrumpRx is to im­prove price trans­paren­cy, not to be a large mar­ket­place for dis­count­ed med­i­cines.

Chris Klomp, head of Medicare and chief coun­selor to HHS Sec­re­tary Robert F. Kennedy Jr., on Thurs­day tamped down ex­pec­ta­tions for the White House’s di­rect-to-con­sumer med­i­cines hub when asked at a STAT News event how many Amer­i­cans he hopes to reach.

“TrumpRx right now is a cash-pay-on­ly mar­ket,” Klomp said. “And so the goal was not ac­tu­al­ly some mas­sive reach.”

The FDA will now con­sid­er grant­i­ng its re­gen­er­a­tive med­i­cine des­ig­na­tions to ex­per­i­men­tal ther­a­pies even if they are on clin­i­cal hold, a shift in op­er­at­ing pro­ce­dures that could help small­er biotechs de­vel­op­ing cell and gene ther­a­pies to treat se­ri­ous con­di­tions.

The Re­gen­er­a­tive Med­i­cine Ad­vanced Ther­a­py (RMAT) des­ig­na­tion al­lows com­pa­nies to work ear­li­er and more close­ly with the FDA on an ap­pli­ca­tion, and it in­cludes all the ben­e­fits of the agen­cy's oth­er fast track and break­through des­ig­na­tion pro­grams.

While the agency pre­vi­ous­ly made clear in guid­ance and on its web­site that it will not grant an RMAT des­ig­na­tion "if an IND is on hold or is placed on hold dur­ing the des­ig­na­tion re­view," the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search said in an up­date this week that it's chang­ing course.

The FDA ap­proved a high-dose ver­sion of No­vo Nordisk's block­buster weight loss in­jec­tion We­govy, giv­ing its go-ahead about two months faster than nor­mal thanks to a vouch­er re­ceived from the com­mis­sion­er's pro­gram.

Thurs­day's ap­proval is based on da­ta re­leased in Jan­u­ary, when No­vo re­port­ed that pa­tients giv­en the 7.2 mg dose had an av­er­age weight loss of 20.7% af­ter 72 weeks. That was bet­ter than the 17.5% weight loss for peo­ple giv­en the al­ready-ap­proved 2.4 mg dose in the tri­al.

While the high-dose We­govy is stronger than the pre­vi­ous­ly ap­proved ver­sion, it is slight­ly be­hind its com­peti­tor, Eli Lil­ly's Zep­bound. In its piv­otal tri­al, the 15 mg dose of Lil­ly’s GIP/GLP-1 ag­o­nist, ap­proved in No­vem­ber 2023, achieved 22.5% weight loss at 72 weeks.