Bris­tol My­ers Squibb re­cent­ly joined 11 of its peer phar­ma com­pa­nies in lim­it­ing how many con­tract phar­ma­cies can ac­cess cer­tain drugs dis­count­ed by a fed­er­al pro­gram known as 340B.

Bris­tol My­ers is just the lat­est in a se­ries of high-pro­file phar­ma com­pa­nies mov­ing in their own di­rec­tion as the Biden ad­min­is­tra­tion’s Health Re­sources and Ser­vices Ad­min­is­tra­tion strug­gles to rein in the drug dis­count pro­gram for the need­i­est Amer­i­cans.

Es­tab­lished in 1992, 340B is a fed­er­al health pro­gram that re­quires phar­ma com­pa­nies to of­fer steep dis­counts on their drugs to hos­pi­tals that treat low-in­come pa­tients. But in the last few years, large phar­mas start­ed set­ting their own re­stric­tions on the bal­loon­ing pro­gram, claim­ing that hos­pi­tals are us­ing an un­lim­it­ed num­ber of so-called “con­tract” phar­ma­cies — an out­side phar­ma­cy not owned by the hos­pi­tal — to ob­tain more dis­counts.

The ad­min­is­tra­tion has strug­gled to deal with what phar­ma com­pa­nies see as a pro­gram that’s grown to al­most 10% of the en­tire US phar­ma mar­ket.

Be­gin­ning March 1, 2022, BMS said it will on­ly rec­og­nize up to two des­ig­nat­ed 340B con­tract phar­ma­cy lo­ca­tions (in­clud­ing one for its block­buster mul­ti­ple myelo­ma drugs like Revlim­id and Po­m­a­lyst) per 340B hos­pi­tal that lacks an en­ti­ty-owned phar­ma­cy. Oth­er sim­i­lar moves have cost hos­pi­tals sig­nif­i­cant­ly in lost sav­ings from the dis­count pro­gram. 

Re­cent court de­ci­sions, while con­flict­ing on how com­pa­nies can pro­ceed with their lim­its on con­tract phar­ma­cies, not­ed that Mass­a­chu­setts-based Bev­er­ly Hos­pi­tal says it lost more than $125,000 in 340B sav­ings since Sanofi’s 340B changes took ef­fect. And, they not­ed, Rochester, NY-based Strong Memo­r­i­al Hos­pi­tal said that No­vo Nordisk and oth­er drug­mak­ers “re­fused to of­fer drugs at the 340B ceil­ing price, re­sult­ing in over­charges of more than $2 mil­lion.”

Ac­cord­ing to Bri­an Reid at Re­al Chem­istry’s week­ly newslet­ter, the Bris­tol My­ers move, as well as oth­er com­pa­nies’ sim­i­lar ones, means that re­stric­tions on 340B pric­ing are now in place for eight of the top 10 best-sell­ing drugs in the US, and six of those re­stric­tions have been im­posed since Dec. 1.

HRSA is work­ing on a new pro­posed rule­mak­ing re­lat­ed to its Ad­min­is­tra­tive Dis­pute Res­o­lu­tion rule, which would es­tab­lish new re­quire­ments and pro­ce­dures for the 340B pro­gram’s process. These pro­ce­dures would set up a method for hos­pi­tals and phar­ma com­pa­nies to re­solve dis­putes.

But pur­suant to a court or­der, HRSA is cur­rent­ly en­joined from en­forc­ing these reg­u­la­tions against Eli Lil­ly.

Mau­reen Testoni, pres­i­dent and CEO of the hos­pi­tal as­so­ci­a­tion 340B Health, said Bris­tol My­ers, the 12th drug com­pa­ny “to vi­o­late the 340B statute,” will “weak­en the health care safe­ty net and harm pa­tients who re­ly on 340B providers for ac­cess to af­ford­able drugs and care while en­rich­ing the com­pa­ny and its stock­hold­ers. In 2020, BMS re­port­ed $42.5 bil­lion in rev­enues, with its can­cer drug Revlim­id ac­count­ing for more than $12 bil­lion.”

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.