As the speed of biotech in­no­va­tion out­paces reg­u­la­tors, a new re­port from the Na­tion­al Se­cu­ri­ty Com­mis­sion on Emerg­ing Biotech­nol­o­gy is rec­om­mend­ing al­most two dozen pol­i­cy changes to help the FDA nav­i­gate the space.

The bi­par­ti­san NSCEB, cre­at­ed by Con­gress in 2022 to re­view emerg­ing biotech ad­vance­ments, is tak­ing is­sue with the way the FDA is reg­u­lat­ing cer­tain bio­phar­ma com­pa­nies and is call­ing on Con­gress to take ac­tion.

For in­stance, the NSCEB says Con­gress should “re­quire that the FDA use for­mal no­tice-and-com­ment rule­mak­ing” to cre­ate FDA Com­mis­sion­er Mar­ty Makary and bi­o­log­ics di­rec­tor Vinay Prasad’s new "plau­si­ble mech­a­nism" path­way to ap­prove cer­tain rare dis­ease ther­a­pies.

The FDA asked man­u­fac­tur­ers of a half-dozen flu vac­cines to up­date their la­bels to men­tion the risk of febrile seizures, which are con­vul­sions caused by fevers in young chil­dren.

In let­ters last Fri­day, the agency said its de­ci­sion to up­date the la­bels was based on da­ta from the 2023-2024 and 2024-2025 sea­sons as it looked in­to three com­mer­cial in­sur­ance claims da­ta sources in self-con­trolled case se­ries analy­ses. The re­view iden­ti­fied "sig­nif­i­cant­ly in­creased risks of febrile seizures in the first day fol­low­ing in­fluen­za vac­ci­na­tion," the let­ters say.

The tar­get­ed prod­ucts in­clud­ed GSK's Flulaval and Flu­ar­ix, As­traZeneca's Flu­Mist, CSL Se­qirus' Afluria and Flucel­vax, and Sanofi's Flu­zone. The com­pa­nies did­n't im­me­di­ate­ly re­spond to re­quests for com­ment.

HHS con­firmed that it en­list­ed Pfiz­er to help com­bat the short­age of a drug that Robert F. Kennedy Jr.'s de­part­ment is pro­mot­ing as a po­ten­tial new autism drug de­spite shaky ev­i­dence.

Pfiz­er told health­care providers in a let­ter dat­ed last month that the FDA asked it to help by co­or­di­nat­ing to tem­porar­i­ly im­port un­ap­proved ver­sions of leu­cov­orin sourced in Cana­da and made by the Span­ish con­tract man­u­fac­tur­er Far­masier­ra. An HHS spokesper­son con­firmed to End­points News that Pfiz­er helped with the im­ports from Cana­da.

The FDA asked No­vo Nordisk and Eli Lil­ly to re­move warn­ings about sui­ci­dal ideation or be­hav­ior from the la­bels of their block­buster GLP-1 weight loss drugs.

Novo's Sax­en­da and We­govy, as well as Lil­ly's Zep­bound, were sin­gled out for la­bel up­dates fol­low­ing "a com­pre­hen­sive FDA re­view" that found no in­creased risk of such sui­ci­dal ten­den­cies. The agency said Tues­day it wants to "en­sure con­sis­tent mes­sag­ing," since la­bels on oth­er GLP-1s that were ap­proved to im­prove blood sug­ar con­trol or di­a­betes com­pli­ca­tions don't cur­rent­ly de­scribe a risk of SI/B.

Clin­i­cal tri­al da­ta found no as­so­ci­a­tion be­tween the use of GLP-1s and sui­ci­dal thoughts and ac­tions, the FDA said, while not­ing a few in­stances were ob­served in in­di­vid­ual tri­als. FDA said its com­pre­hen­sive meta-analy­sis of 91 place­bo-con­trolled clin­i­cal tri­als across GLP-1 de­vel­op­ment pro­grams "did not show an in­creased risk for SI/B or for oth­er rel­e­vant psy­chi­atric ad­verse events such as anx­i­ety, de­pres­sion, ir­ri­tabil­i­ty, or psy­chosis."

The FDA is tak­ing steps to ease some man­u­fac­tur­ing re­quire­ments for cell and gene ther­a­pies in an ef­fort to ex­pe­dite their de­vel­op­ment.

Tra­di­tion­al­ly, the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search has used the same chem­istry, man­u­fac­tur­ing and con­trol re­quire­ments for all dif­fer­ent types of ther­a­pies, but cell and gene ther­a­py prod­ucts are more com­pli­cat­ed to make and are of­ten in­di­vid­u­al­ized for pa­tients, the FDA said Sun­day.

The agency said it rec­og­nizes that since the pa­tient pop­u­la­tions for CGTs are small­er com­pared to oth­er drugs, com­pa­nies can't show large batch num­bers when sub­mit­ting a CGT prod­uct for ap­proval. As a re­sult, the FDA said it will be more flex­i­ble in its prod­uct re­lease spec­i­fi­ca­tions for new CGTs.

The FDA has once again re­ject­ed a T cell ther­a­py for a rare and se­ri­ous trans­plant com­pli­ca­tion re­lat­ed to Ep­stein-Barr virus.

Atara Bio­ther­a­peu­tic­s' treat­ment, called tab­ele­cleu­cel or tab-cel, is de­signed to treat pa­tients with Ep­stein-Barr virus pos­i­tive post-trans­plant lym­pho­pro­lif­er­a­tive dis­ease (PTLD) who have re­ceived at least one pri­or ther­a­py. The FDA re­ject­ed the drug again af­ter de­ter­min­ing that the sin­gle-arm study was "no longer con­sid­ered to be ad­e­quate" as a ba­sis for ap­proval de­spite pre­vi­ous­ly say­ing so, ac­cord­ing to Atara in a Mon­day re­lease.

The agency had al­ready pre­vi­ous­ly re­ject­ed tab-cel in Jan­u­ary 2025 due to “in­spec­tion find­ings at a third-par­ty man­u­fac­tur­er.” Those is­sues were reme­died in the new sub­mis­sion, Atara said in the re­lease.