Many re­cent an­tibi­ot­ic ap­provals from the FDA are based on few­er, small­er and less rig­or­ous piv­otal tri­als, which rais­es fresh ques­tions about what new in­cen­tive pro­grams might do for the an­tibi­otics in­dus­try, re­searchers from Har­vard Med­ical School and George Wash­ing­ton Uni­ver­si­ty School of Med­i­cine wrote in the BMJ this week.

The find­ings high­light the need for not on­ly new an­tibi­otics, but al­so ones that show clin­i­cal­ly rel­e­vant ev­i­dence of ef­fec­tive­ness and added ben­e­fits for the pa­tient, they wrote.

“Bot­tom line is that of the new an­tibi­otics ap­proved from 2016-2019, near­ly all were based on few­er, small­er and non-in­fe­ri­or­i­ty piv­otal tri­als that of­ten used sur­ro­gate out­come mea­sures but were com­mon­ly more cost­ly,” co-au­thor Aaron Kessel­heim, a pro­fes­sor at Har­vard, told End­points News.

He al­so said the find­ings sug­gest that the bi­par­ti­san PAS­TEUR Act, which aims to in­cen­tivize new an­tibi­ot­ic de­vel­op­ment, “is a pre­scrip­tion for wast­ed mon­ey un­less it in­cludes a re­quire­ment that drug show im­prove­ments in clin­i­cal out­comes.”

The PhRMA-backed PAS­TEUR Act would in­cen­tivize com­pa­nies by of­fer­ing sub­scrip­tion-based con­tracts un­der fed­er­al health care pro­grams.

Sim­i­lar cri­tiques of the bill were laid out in a let­ter to the bill’s spon­sors last month from sev­er­al physi­cians in­clud­ing Joseph Ross and Resh­ma Ra­machan­dran of Yale School of Med­i­cine, as the PAS­TEUR Act may hitch a ride on one of the year-end spend­ing bills.

“Un­der the PAS­TEUR Act, tax­pay­er dol­lars will be wast­ed as a blank check to phar­ma­ceu­ti­cal man­u­fac­tur­ers for an­timi­cro­bials of lim­it­ed ben­e­fit,” they wrote.

An­timi­cro­bial-re­sis­tant in­fec­tions in­fect as many as three mil­lion Amer­i­cans every year and kill about 50,000 peo­ple, they not­ed, so the race for a so­lu­tion is time sen­si­tive.

But the re­searchers show in their BMJ study that of 15 new an­tibi­otics that re­cent­ly won ap­proval, more than half of the piv­otal tri­als used an ac­tive con­trol non-in­fe­ri­or­i­ty de­sign, and all drugs were ap­proved based on sur­ro­gate out­come mea­sures.

The val­ue of these new an­tibi­otics “is not al­ways clear based on test­ing be­fore ap­proval by the FDA,” they wrote, adding:

Ef­forts like the PAS­TEUR Act deal with the bar­ri­er of low sales po­ten­tial to new an­tibi­ot­ic de­vel­op­ment but might not ac­count for whether these drugs pro­vide suf­fi­cient added ben­e­fit to the pa­tient to jus­ti­fy pay­ment. In­creas­ing the num­ber of agents com­ing to mar­ket should bal­ance the ro­bust­ness of ev­i­dence of im­proved di­rect pa­tient out­comes com­pared with cur­rent stan­dards of care, there­fore meet­ing the needs of pa­tients.

Kessel­heim added: “I think an im­por­tant thing to be in­clud­ed in the PAS­TEUR Act – since the idea be­hind the Act is to bol­ster the pipeline of an­tibi­ot­ic de­vel­op­ment giv­en the need brought on by AMR – is a re­quire­ment that for drugs to qual­i­fy, they need to be shown in con­trolled tri­als to im­prove ac­tu­al clin­i­cal out­comes in pa­tients with an­timi­cro­bial re­sis­tant in­fec­tions.”

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

The DC Circuit Court has struck a blow against the pharmaceutical lobbying group PhRMA and other plaintiffs’ attempt to stop states from importing drugs from Canada.

Joined alongside public health group Partnership for Safe Medicines and advocacy group Council for Affordable Health Coverage, PhRMA was rebuffed by Judge Timothy Kelly on Monday, who dismissed the civil suit due to a lack of standing.

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”