The House is set to vote this week on a bi­par­ti­san bill to keep the gov­ern­ment open be­yond Jan. 30, with new pro­pos­als to change how phar­ma­cy ben­e­fit man­agers op­er­ate and to reau­tho­rize a lapsed FDA vouch­er pro­gram for rare pe­di­atric drugs.

The spend­ing bill, which the Sen­ate is ex­pect­ed to vote on next week, fea­tures PBM re­forms that have been float­ed for years, in­clud­ing re­quire­ments that HHS re­view the fees or oth­er forms of com­pen­sa­tion paid to PBMs or their af­fil­i­ates. The bill would al­so re­quire PBMs to give HHS and in­sur­ers a new an­nu­al re­port that in­cludes drug pric­ing and re­bate da­ta, as well as writ­ten jus­ti­fi­ca­tions in sev­er­al ar­eas — such as for pro­vid­ing more fa­vor­able cov­er­age for a ref­er­ence bi­o­log­ic rather than a biosim­i­lar.

As Chi­na sees in­creased biotech in­vest­ments, li­cens­ing deals and faster ear­ly-phase clin­i­cal tri­al starts, FDA Com­mis­sion­er Mar­ty Makary said his agency is re­work­ing Phase 1 tri­al reg­u­la­tions to speed that en­try process and tweak­ing user fees to en­cour­age R&D in the US.

"We can come up with some pro­tec­tion strate­gies, but ul­ti­mate­ly, what we need to do is be more com­pet­i­tive with what's go­ing on with Phase 1s" and in­ves­ti­ga­tion­al new drug ap­pli­ca­tions, Makary told the "All-In Pod­cast" in a near­ly 90-minute in­ter­view, re­fer­ring to the way Chi­na has in­creas­ing­ly sped up the ac­ti­va­tion of new ear­ly-phase tri­als.

Makary al­so said he's go­ing to help in­cen­tivize US-based drug de­vel­op­ment by charg­ing com­pa­nies high­er fees if they de­vel­op their drugs out­side of the coun­try.

The US Supreme Court has agreed to re­view a gener­ic drug la­bel rul­ing that Hik­ma Phar­ma­ceu­ti­cals says could “ef­fec­tive­ly vi­ti­ate” a com­mon prac­tice for bring­ing low-cost med­ica­tions to mar­ket.

The jus­tices on Fri­day grant­ed Hik­ma’s pe­ti­tion to re­view a de­ci­sion by the US Court of Ap­peals for the Fed­er­al Cir­cuit, which re­vived Amarin’s patent law­suit against Hik­ma. The law­suit claims that Hik­ma en­cour­aged physi­cians to pre­scribe a gener­ic ver­sion of Amarin’s Vas­cepa for an in­fring­ing use, even though Hik­ma left Amarin’s patent­ed in­di­ca­tion off the gener­ic’s la­bel.

The case gives the high court the chance to weigh in on the prac­tice known as “skin­ny la­bel­ing” and clar­i­fy the ex­tent to which gener­ic drug­mak­ers may still be held li­able in court, even when their prod­uct is on­ly la­beled for un-patent­ed us­es. The US so­lic­i­tor gen­er­al in De­cem­ber had urged the jus­tices to take the case.

John­son & John­son, which has sev­er­al drugs ap­proved for mul­ti­ple myelo­ma, praised the FDA's just-re­leased draft guid­ance on how the agency will al­low the use of min­i­mal resid­ual dis­ease as a pri­ma­ry end­point for ac­cel­er­at­ed ap­provals of treat­ments for the blood can­cer.

The nine-page draft pub­lished Tues­day spells out how drug de­vel­op­ers can use MRD as an end­point in sev­er­al ways, in­clud­ing via a sin­gle-arm tri­al, with the on­go­ing tri­al con­tin­u­ing to eval­u­ate pro­gres­sion-free-sur­vival or over­all sur­vival to sup­port a full ap­proval. An FDA ad­vi­so­ry com­mit­tee in 2024 vot­ed unan­i­mous­ly to al­low the use of MRD as an end­point.

J&J pi­o­neered much of the ev­i­dence be­hind the use of MRD, EVP John Reed said on Wednes­day's earn­ings call, "so we’re ex­cit­ed that that is an op­tion."

Pres­i­dent Don­ald Trump wants new leg­is­la­tion that ce­ments his "most fa­vored na­tion" deals with drug­mak­ers, ask­ing Con­gress to put the drug price dis­counts in­to law that the phar­ma in­dus­try has so far vol­un­tar­i­ly agreed to.

In a video state­ment re­leased Thurs­day, Trump called for a broad set of health­care re­forms that in­clude cod­i­fy­ing MFN pric­ing. He said he want­ed Con­gress to “com­plete the work that we’ve start­ed” and re­it­er­at­ed that he wants Amer­i­cans to pay the low­est drug prices in the world.

It’s not clear what ex­act­ly would be cod­i­fied, giv­en that the pre­cise terms of the deals struck with 16 large phar­mas have not been pub­licly re­leased. The com­pa­nies that have signed deals with the White House so far have agreed to pro­vide sup­ple­men­tal re­bates to Med­ic­aid through a vol­un­tary pi­lot pro­gram and sell se­lect med­i­cines at a dis­count di­rect­ly to cash-pay­ing pa­tients. They've al­so agreed to launch new prod­ucts at MFN prices.