The Supreme Court re­cent­ly de­clined to wade in­to a fight over a state’s reg­u­la­tion of phar­ma­cy ben­e­fit man­agers. But le­gal ex­perts say it like­ly won’t be the last time the broad­er is­sue makes its way up to the high court.

The jus­tices left in place an ap­pel­late court de­ci­sion against cer­tain pro­vi­sions in an Ok­la­homa law that im­posed re­quire­ments on PBMs and their phar­ma­cy net­works. The case could have of­fered clar­i­ty on an is­sue that has trig­gered a wave of lit­i­ga­tion. But in­stead, low­er courts in oth­er cir­cuits are left to nav­i­gate a com­plex web of cas­es as states con­tin­ue to crack down on the en­ti­ties that have come un­der fire for their role in drug pric­ing.

A group of or­ga­ni­za­tions rep­re­sent­ing thou­sands of doc­tors na­tion­wide sued HHS Sec­re­tary Robert F. Kennedy Jr. over his de­ci­sion to change Covid-19 vac­cine rec­om­men­da­tions for kids and preg­nant women.

The fed­er­al law­suit filed Mon­day in Mass­a­chu­setts is led by the Amer­i­can Acad­e­my of Pe­di­atrics and al­leges that Kennedy's ac­tion “im­me­di­ate­ly ex­pos­es these vul­ner­a­ble pop­u­la­tions to a se­ri­ous ill­ness with po­ten­tial­ly ir­re­versible long-term ef­fects and, in some cas­es, death.”

“This is not a hy­po­thet­i­cal con­cern, but a press­ing pub­lic health emer­gency that de­mands im­me­di­ate le­gal ac­tion and cor­rec­tion,” ac­cord­ing to the com­plaint. The plain­tiffs are look­ing to over­turn Kennedy’s di­rec­tive that in­sti­tut­ed the change.

Pres­i­dent Don­ald Trump on Ju­ly 4 signed in­to law his wide-rang­ing tax cuts and rec­on­cil­i­a­tion pack­age, in­clud­ing an ex­pan­sion of or­phan drug pro­tec­tions from Medicare ne­go­ti­a­tions, and near­ly $1 tril­lion in Med­ic­aid cuts that could up­end the op­er­a­tions of hos­pi­tals that pro­vide cheap­er drugs and care un­der the 340B fed­er­al pro­gram.

The or­phan drug pro­vi­sion is a sig­nif­i­cant win for the drug in­dus­try. Un­der the law, which is for­mal­ly called the One Big Beau­ti­ful Bill Act, any or­phan or rare dis­ease drugs, po­ten­tial­ly in­clud­ing block­busters with mul­ti­ple or­phan in­di­ca­tions, won't face Medicare price ne­go­ti­a­tions un­der the In­fla­tion Re­duc­tion Act.

Nei­ther of the first two rounds of drugs se­lect­ed for ne­go­ti­a­tion in­clud­ed or­phan drugs. But the phar­ma in­dus­try raised con­cerns that the way the IRA was writ­ten could lim­it the ex­clu­sion to on­ly drugs with one rare dis­ease in­di­ca­tion.

FDA Com­mis­sion­er Mar­ty Makary pledged to "mean­ing­ful­ly re­duce" un­nec­es­sary an­i­mal test­ing that's cur­rent­ly used to bring new drugs to mar­ket and to test them in ear­ly de­vel­op­men­tal stages.

While Makary's pro­pos­al is light on specifics, a re­duc­tion of an­i­mal test­ing could low­er R&D costs, speed up drug de­vel­op­ment, and "po­ten­tial­ly even trans­late in­to low­er drug prices," Makary said at an FDA-NIH work­shop at the FDA's head­quar­ters on Mon­day.

"One of our biggest goals is to re­duce an­i­mal test­ing in a way that's mean­ing­ful and con­tin­ues to pro­tect against pub­lic safe­ty," he added.

Makary's FDA in April said an­i­mal test­ing re­quire­ments, which vary de­pend­ing on the type of drug in de­vel­op­ment, will be "re­duced, re­fined, or po­ten­tial­ly re­placed" via "a range of ap­proach­es, in­clud­ing AI-based com­pu­ta­tion­al mod­els of tox­i­c­i­ty and cell lines and organoid tox­i­c­i­ty test­ing in a lab­o­ra­to­ry set­ting."