The Sen­ate has unan­i­mous­ly cleared an amend­ment to the an­nu­al de­fense pol­i­cy bill that would al­low the FDA to re­tain sole pow­er to ap­prove drugs and med­ical de­vices. The move comes just days af­ter the bill’s pol­i­cy lan­guage sparked con­tro­ver­sy about the Pen­ta­gon usurp­ing the FDA’s pow­er.

As first writ­ten, the bill would have giv­en the Pen­ta­gon au­thor­i­ty to OK the use of ex­per­i­men­tal and un­ap­proved drugs and med­ical de­vices for emer­gency use on mil­i­tary per­son­nel and “in­di­vid­u­als as­so­ci­at­ed with de­ployed mem­bers of the armed forces.” The hope was that cer­tain un­ap­proved prod­ucts could “re­duce deaths and sever­i­ty of in­juries caused by agents of war.”

Scott Got­tlieb

First re­port­ed by Politi­co, the bill’s vague lan­guage con­cerned con­gres­sion­al staff, Health and Hu­man Ser­vices of­fi­cials, and FDA Com­mis­sion­er Scott Got­tlieb.

The pro­vi­sion was sought by the DoD, in part, so it could fast-track ap­proval of freeze-dried plas­ma for sol­diers, which it’s thought could save the lives of sol­diers on the bat­tle­field.

The con­tro­ver­sial lan­guage prompt­ed ne­go­ti­a­tions be­tween the agen­cies and re­sult­ed in a com­pro­mise. The new lan­guage pre­serves the FDA’s au­thor­i­ty, while ex­pe­dit­ing some treat­ments for Pen­ta­gon needs and in­creas­ing the com­mu­ni­ca­tion be­tween the DoD and the FDA.

En­hanced col­lab­o­ra­tion be­tween the agen­cies means the FDA will meet with the DoD twice a year to “con­duct a full re­view of the rel­e­vant prod­ucts in the De­part­ment of De­fense port­fo­lio.” The FDA will al­so meet quar­ter­ly with the Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty to dis­cuss “the sta­tus of re­gen­er­a­tive med­i­cine ad­vanced ther­a­py, blood, and vac­cine med­ical prod­ucts and projects that are the high­est pri­or­i­ties to the De­part­ment of De­fense (which may in­clude freeze dried plas­ma prod­ucts and platelet al­ter­na­tives),” the amend­ment states.

Read the full text of the bill’s amend­ment.