Re­pub­li­can sen­a­tors are speak­ing out against a pro­posed test mod­el in which drug­mak­ers would ef­fec­tive­ly make less for drugs ap­proved via the FDA’s ac­cel­er­at­ed ap­proval.

The test pro­gram, dubbed the Ac­cel­er­at­ing Clin­i­cal Ev­i­dence Mod­el, was an­nounced last month as a way to in­cen­tivize quick­er con­fir­ma­to­ry tri­als and “re­duce Medicare spend­ing on drugs that have no con­firmed clin­i­cal ben­e­fit.” HHS Sec­re­tary Xavier Be­cer­ra di­rect­ed CMS to be­gin con­sul­ta­tion with the FDA on the mod­el this year.

How­ev­er, 18 Re­pub­li­can sen­a­tors urged Be­cer­ra and CMS Ad­min­is­tra­tor Chiq­ui­ta Brooks-La­Sure not to pur­sue the mod­el in a let­ter on Wednes­day.

“By bring­ing ground­break­ing ther­a­pies to pa­tients years be­fore these prod­ucts could oth­er­wise reach the mar­ket, the FDA’s Ac­cel­er­at­ed Ap­proval Pro­gram (AAP) has saved count­less lives while up­hold­ing strong safe­guards and stan­dards,” they wrote. “The Ac­cel­er­at­ing Clin­i­cal Ev­i­dence Mod­el re­cent­ly an­nounced by the Biden Ad­min­is­tra­tion, un­for­tu­nate­ly, risks un­der­min­ing or even re­vers­ing this trend, trig­ger­ing ac­cess gaps for se­niors, as well as im­pos­ing cuts on front­line providers.”

In an Oc­to­ber re­port, HHS’ in­spec­tor gen­er­al said that Medicare and Med­ic­aid spent more than $18 bil­lion from 2018 to 2021 for ther­a­pies with in­com­plete con­fir­ma­to­ry tri­als past their orig­i­nal planned com­ple­tion dates.

“Giv­en the in­creas­ing num­ber of AAP ap­provals, some ex­perts are con­cerned the num­ber of past-due tri­als may con­tin­ue to in­crease,” the re­port states. Con­gress and Pres­i­dent Joe Biden re­cent­ly signed off on new au­thor­i­ty for the FDA to be­gin re­quir­ing con­fir­ma­to­ry tri­als pri­or to an ap­proval.

Last month, a CMS spokesper­son told End­points News that the agency is “still ex­plor­ing the spe­cif­ic ap­proach­es to pay­ment ad­just­ments in the Ac­cel­er­at­ing Clin­i­cal Ev­i­dence Mod­el, and any ap­proach will be de­vel­oped in close co­or­di­na­tion with the Food and Drug Ad­min­is­tra­tion.”

While HHS’ re­port claimed that any ad­just­ments would be made “in a man­ner that at­tempts to avoid pe­nal­iz­ing physi­cians or ben­e­fi­cia­ries for choos­ing (or avoid­ing) an ac­cel­er­at­ed ap­proval treat­ment,” the sen­a­tors ar­gued on Wednes­day that cer­tain con­fir­ma­to­ry tri­als may still take years to com­plete in dif­fi­cult dis­eases such as Alzheimer’s or some can­cers.

“Puni­tive treat­ment of prod­ucts that opt for ac­cel­er­at­ed ap­proval sends a pre­car­i­ous sig­nal to pa­tients, providers, pay­ers, and the pub­lic that CMS lacks con­fi­dence in this life-sav­ing path­way,” they wrote.

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”