The FDA qui­et­ly an­nounced on Tues­day that just be­fore New Year’s eve, the agency again paused all of its non-mis­sion-crit­i­cal in­spec­tions in the US, like­ly lead­ing to an even larg­er back­log of in­spec­tions world­wide.

The pause, which will last at least two weeks, is meant to en­sure the safe­ty of FDA em­ploy­ees and the com­pa­nies it reg­u­lates as the agency fur­ther adapts to the spread of Omi­cron.

“Through Jan.19, the agency in­tends to con­tin­ue mis­sion-crit­i­cal work but has tem­porar­i­ly post­poned cer­tain in­spec­tion­al ac­tiv­i­ties with the hopes of restart­ing these ac­tiv­i­ties as soon as pos­si­ble,” the FDA said in a state­ment.

The agency had on­ly just re­turned to rel­a­tive­ly nor­mal do­mes­tic in­spec­tions last Ju­ly, af­ter a long pre­vi­ous pause that be­gan as the pan­dem­ic hit in ear­ly 2020. In a re­port from last No­vem­ber, the agency not­ed that 52 new drug ap­pli­ca­tions were de­layed as a re­sult of the in­spec­tion back­log cre­at­ed by that long pause.

On the for­eign in­spec­tion side, where ac­tiv­i­ties have still been most­ly on pause since ear­ly 2020, FDA said it’s post­pon­ing the plan­ning of pri­or­i­tized sur­veil­lance for­eign in­spec­tion as­sign­ments that were sched­uled to be­gin in Feb­ru­ary 2022.

But the FDA said it will con­tin­ue con­duct­ing mis­sion-crit­i­cal for­eign and do­mes­tic in­spec­tions.

Be­tween April and Sep­tem­ber 2021, the FDA said it com­plet­ed just 37 for­eign drug in­spec­tions, which com­pares with more than 1,200 in 2019.

And the FDA’s to­tal tal­ly for drug and bi­o­log­ic in­spec­tions in 2020 shows how the agency con­duct­ed 1,500 few­er in­spec­tions in 2020, when com­pared to 2019 (and over 2,600 few­er when com­pared to 2011). On­ly 74 in­spec­tions end­ed with an Of­fi­cial Ac­tion In­di­cat­ed in 2020, which com­pared with 202 OAIs in 2019.

The agency has sought to shift to more re­mote as­sess­ments of fa­cil­i­ties, but that hasn’t proven to be a ma­jor help as the back­log is filled most­ly with sur­veil­lance in­spec­tions, and the le­gal de­f­i­n­i­tion of an in­spec­tion is one that is con­duct­ed on site.

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

In a first for 2022, the FDA’s Office of Prescription Drug Promotion has issued an untitled letter, which was recently sent to Eli Lilly over what the agency calls a “misleading” and “particularly concerning” Instagram ad the company posted for its type 2 diabetes drug Trulicity.

The questionable Instagram post, which has since been deleted by Lilly, failed to adequately communicate the indication and limitations of use associated with Trulicity, FDA says.

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.

Two monoclonal antibody combos from Eli Lilly and Regeneron are no longer authorized in the US, and shipments to states have ceased because HHS said they are “highly unlikely” to work against the sweeping new variant Omicron.

The move by the FDA comes as states like Florida have become insistent that the mAbs need to be independently evaluated, although the federal Department of Health and Human Services, which has shipped hundreds of thousands of these two mAbs to states in recent weeks, did not ship any this week.

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.