Now Eli Lil­ly has an obe­si­ty pill, too.

On Wednes­day, the FDA ap­proved or­for­glipron, the agency an­nounced. It will be sold as Foun­dayo, and Lil­ly has pre­vi­ous­ly said it plans to sell a start­ing dose for $149 a month and high­er dos­es for up to $349 a month.

The ini­tial price ris­es to $349 for sub­se­quent dos­es if the pa­tient does not re­fill with­in a 45-day win­dow, a Lil­ly spokesper­son con­firmed to End­points News. If they do re­fill with­in that time, it would be a max­i­mum of $299 per month through the Foun­dayo self-pay pro­gram.

The pill was ap­proved un­der the FDA's new Com­mis­sion­er's Na­tion­al Pri­or­i­ty Vouch­er pro­gram, an ex­pe­dit­ed re­view path­way that sparked both promise and con­cern when it launched last year. The agency claimed that Foun­dayo was the fastest ap­proval of a new mol­e­c­u­lar en­ti­ty in more than two decades.

Bio­phar­ma in­dus­try rep­re­sen­ta­tives are tak­ing is­sue with some of the FDA’s more po­lit­i­cal pro­pos­als in the next round of user fee agree­ments, par­tic­u­lar­ly ones that would lim­it the small busi­ness waiv­er to on­ly US ap­pli­cants and re­duce user fees for com­pa­nies that run their Phase 1 tri­als in the US.

Among the in­dus­try con­cerns: Is PDU­FA "the most ap­pro­pri­ate mech­a­nism" for in­cen­tiviz­ing more clin­i­cal de­vel­op­ment in the US? That's ac­cord­ing to the lat­est meet­ing min­utes from a se­ries of Feb­ru­ary ne­go­ti­a­tions lead­ing up to the eighth it­er­a­tion of the pre­scrip­tion drug user fee pro­gram and post­ed on Thurs­day.

The FDA has post­poned its dead­line on whether to ap­prove Or­ca Bio’s T cell ther­a­py by three months to Ju­ly 6.

The agency was ex­pect­ed to reach a ver­dict by April 6, but pushed back the de­ci­sion date af­ter the pri­vate com­pa­ny sub­mit­ted ad­di­tion­al da­ta around the man­u­fac­tur­ing of its cell ther­a­py. Known as Or­ca-T, it is de­signed to cut the risk of chron­ic graft-ver­sus-host dis­ease, a po­ten­tial se­ri­ous com­pli­ca­tion of stem cell trans­plants used for blood can­cer pa­tients.

“As part of that nor­mal re­view process, we had sub­mit­ted quite a bit of da­ta with re­gards to the CMC pack­age late in the re­view cy­cle, in the March time­frame, in re­sponse to some of the FDA ques­tions,” Or­ca Bio co­founder and CEO Nate Fern­hoff told End­points News.

At­tempts by the White House to cur­ry in­dus­try sup­port for leg­is­la­tion that would cod­i­fy last year’s vol­un­tary drug pric­ing deals are be­ing ig­nored by some drug­mak­ers who be­lieve there’s lit­tle to ne­go­ti­ate.

Two sources fa­mil­iar with the White House’s en­gage­ment with in­dus­try said that a num­ber of com­pa­nies have de­clined in­vi­ta­tions to re­view draft leg­isla­tive text. It was not im­me­di­ate­ly clear which com­pa­nies have de­clined, af­ter at least four com­pa­nies met with ad­min­is­tra­tion of­fi­cials ear­li­er this month.

The re­fusals to meet sug­gest a con­cert­ed flip in the re­la­tion­ship be­tween drug­mak­ers and the ad­min­is­tra­tion. Mul­ti­ple large drug­mak­ers told End­points News on con­di­tion of anonymi­ty that they weren’t sup­port­ive of the ef­fort and have held off from en­gag­ing with the ad­min­is­tra­tion. One told End­points that pre­vi­ous threats by CMS Ad­min­is­tra­tor Mehmet Oz that cod­i­fy­ing the deals would avoid po­ten­tial­ly harsh­er leg­is­la­tion down the line from a dif­fer­ent ad­min­is­tra­tion have been met with skep­ti­cism.

Se­nior HHS of­fi­cial and head of Medicare Chris Klomp did­n't mince words when he called com­pe­ti­tion with Chi­na’s as­cend­ing biotech in­dus­try “a war.”

Klomp’s com­ments, made Thurs­day at the an­nu­al Con­ser­v­a­tive Po­lit­i­cal Ac­tion Con­fer­ence in Texas, are the clear­est sign yet that the Trump ad­min­is­tra­tion is pay­ing at­ten­tion to the quick­ly shift­ing glob­al drug de­vel­op­ment land­scape. And they may be a pre­lude to some of the re­forms that the in­dus­try has been clam­or­ing for.

“We face a na­tion­al se­cu­ri­ty threat right now that has­n't been named mean­ing­ful­ly un­til Pres­i­dent Trump,” Klomp said. “It's not one of mis­siles and tanks. It's of lab­o­ra­to­ries and life-sav­ing med­ica­tions. It's a war right now with Chi­na on Amer­i­can in­no­va­tion and biotech­nol­o­gy.”