More than a dozen food and drug law ex­perts ar­gued on Wednes­day that yank­ing the med­ica­tion abor­tion drug mifepri­s­tone from the mar­ket would “un­der­mine the drug ap­proval process far be­yond the con­text of mifepri­s­tone’s ap­proval.”

The com­ments are in re­sponse to a Texas law­suit chal­leng­ing the 2000 ap­proval of mifepri­s­tone, which is used in com­bi­na­tion with miso­pros­tol to end preg­nan­cies with­in the first 10 weeks. Nine­teen schol­ars from sev­er­al uni­ver­si­ties — in­clud­ing Har­vard and Stan­ford’s law schools — ar­gued in an am­i­cus brief that a pre­lim­i­nary or­der to with­draw mifepri­s­tone’s ap­proval would be “un­prece­dent­ed and in­ap­pro­pri­ate.”

“Fi­nal­ly, over­rid­ing FDA’s safe­ty and ef­fi­ca­cy de­ter­mi­na­tion and forc­ing FDA to with­draw a long­stand­ing drug ap­proval would pro­found­ly un­der­mine the statu­to­ry and reg­u­la­to­ry frame­work un­der­pin­ning the ap­proval of new drugs, there­by threat­en­ing pa­tient ac­cess to ther­a­peu­tics and chill­ing in­dus­try re­search and de­vel­op­ment,” they wrote.

The am­i­cus, or “friend of the court,” brief was one of six filed on Wednes­day, in­clud­ing let­ters from the non­prof­it Doc­tors for Amer­i­ca, Re­pub­li­can at­tor­neys gen­er­al and De­mo­c­ra­t­ic at­tor­neys gen­er­al.

While the Re­pub­li­can AGs took is­sue with what they called a “wide-rang­ing mail-or­der abor­tion-drug regime,” De­moc­rats (and one Re­pub­li­can AG) coun­tered that mifepri­s­tone has been “par­tic­u­lar­ly crit­i­cal in pro­vid­ing ac­cess to abor­tion in low-in­come, un­der­served, and rur­al com­mu­ni­ties where pro­ce­dur­al abor­tion may be un­avail­able.”

“And be­cause med­ica­tion abor­tion is the most com­mon method used to ter­mi­nate preg­nan­cy dur­ing the first trimester, elim­i­nat­ing ac­cess to this method will re­sult in more abor­tions tak­ing place lat­er in preg­nan­cy, fur­ther in­creas­ing costs and med­ical risks,” they wrote.

Last month, the FDA urged US Dis­trict Judge Matthew Kac­s­maryk to re­ject a pre­lim­i­nary in­junc­tion re­quest­ed by abor­tion op­po­nents, which would re­quire the with­draw­al of all mifepri­s­tone ap­provals. Reg­u­la­tors ar­gued that a with­draw­al would de­prive peo­ple of a safe and ef­fec­tive drug.

Med­ica­tion abor­tion ac­count­ed for more than half of US abor­tions in 2020, and last month, the FDA ap­proved a mod­i­fi­ca­tion that al­lows cer­tain “spe­cial­ly cer­ti­fied” phar­ma­cies to dis­pense mifepri­s­tone. Pre­vi­ous­ly, poli­cies re­quired pa­tients to re­ceive the drug in a clin­ic, med­ical of­fice or hos­pi­tal, though reg­u­la­tors didn’t en­force in-per­son re­quire­ments at cer­tain times dur­ing the pan­dem­ic.

Up­on con­duct­ing re­views, the FDA said that “there did not ap­pear to be a dif­fer­ence in ad­verse events be­tween pe­ri­ods when in-per­son dis­pens­ing was and was not en­forced.” The mod­i­fi­ca­tion ap­plies to both Dan­co Labs’ brand-name Mifeprex pills and a gener­ic man­u­fac­tured by Gen­Bio­Pro.

“Plain­tiffs are al­so in­cor­rect in as­sert­ing that FDA ap­proved mifepri­s­tone on the ba­sis of in­ad­e­quate ev­i­dence. To the con­trary, FDA has con­duct­ed mul­ti­ple full and com­plete re­views of mifepri­s­tone’s safe­ty and ef­fi­ca­cy, and each time, it act­ed prop­er­ly in de­ter­min­ing that the drug meets the ap­proval stan­dards of the FD­CA and is ap­pro­pri­ate­ly la­beled,” the food and drug schol­ars 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.

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.”

Bluebird bio had expected to submit a BLA for its sickle cell disease gene therapy lovotibeglogene autotemcel, or lovo-cel, by Friday. Now, that deadline is getting punted for at least a couple of weeks.

CEO Andrew Obenshain detailed the update during the company’s full-year earnings call Wednesday morning after the gene therapy specialist reported the development in its Q4 and 2022 report.

“We will likely miss the Q1 2023 submission goal,” Obenshain said, noting the application is fully written and ready to go. But bluebird is still waiting on FDA feedback for the company’s CMC module submitted in early March.