As the FDA has yet to au­tho­rize any state plans to im­port pre­scrip­tion drugs from Cana­da, the Biden ad­min­is­tra­tion called on the US Dis­trict Court for DC late last week to dis­miss a PhRMA law­suit over the im­ports be­cause any po­ten­tial harms re­main spec­u­la­tive.

Biden’s HHS said PhRMA’s “whole­sale at­tack” on the rule that al­lows states to sub­mit such plans to the FDA has not yet af­fect­ed their mem­ber com­pa­nies “in any con­crete way and per­haps nev­er will.”

The call to dis­miss the suit, which aligns the Biden ad­min­is­tra­tion with the Trump pol­i­cy, notes that two pro­pos­als from Flori­da and New Mex­i­co have been sub­mit­ted to FDA, but the agency has not of­fered a time­line for when it will de­cide on ei­ther one.

Law firm Cov­ing­ton & Burl­ing, on be­half of PhRMA, filed a cit­i­zen pe­ti­tion with the FDA in Jan­u­ary to de­ny Flori­da’s ap­pli­ca­tion, and it filed an­oth­er cit­i­zen pe­ti­tion in March call­ing to de­ny New Mex­i­co’s too.

For Flori­da, PhRMA crit­i­cized the pro­pos­al be­cause it does not in­clude the name of a Cana­di­an whole­saler that would be nec­es­sary for the plan to work, and it del­e­gates sig­nif­i­cant re­spon­si­bil­i­ties to a pri­vate sec­tor ven­dor to work out the de­tails. For New Mex­i­co, PhRMA took is­sue be­cause the state did not pro­vide a for­eign sell­er, im­porter, or FDA-reg­is­tered repack­ager or re­la­bel­er, and it pro­vides on­ly the first it­er­a­tion of the list of drugs to be im­port­ed.

But Biden’s HHS ex­plains how the rule al­low­ing the sub­mis­sion of these state pro­pos­als asks noth­ing of PhRMA’s mem­ber com­pa­nies. And be­cause the rule and state pro­pos­al process has on­ly been in the works for a few months, FDA needs time to eval­u­ate whether to ac­cept or de­ny the ap­pli­ca­tions, Biden’s HHS main­tains.

“To even be el­i­gi­ble for au­tho­riza­tion, a pro­gram must sat­is­fy up­front (and con­tin­ue to demon­strate there­after) a host of strin­gent reg­u­la­to­ry re­quire­ments re­lat­ed to pa­tient safe­ty and drug sup­ply chain se­cu­ri­ty, as well as show sig­nif­i­cant cost sav­ings to Amer­i­can con­sumers,” the Biden ad­min­is­tra­tion’s mo­tion to dis­miss says. “FDA pos­sess­es dis­cre­tion to de­ny any pro­pos­al that does not fa­cial­ly meet the reg­u­la­to­ry re­quire­ments. Even if a pro­pos­al is fa­cial­ly com­plete, the agency still may with­hold au­tho­riza­tion.”

Fol­low­ing the court fil­ing, Flori­da Gov. Ron De­San­tis (R) on Fri­day as­sert­ed that it “puts the Biden Ad­min­is­tra­tion on the record in sup­port of the FDA rule,” which he said could po­ten­tial­ly save the state be­tween $80 mil­lion and $150 mil­lion in the first year alone. He al­so pushed the FDA to act quick­ly in de­cid­ing on the pro­pos­al, say­ing, “Florid­i­ans have been wait­ing long enough for low­er drug prices, and there is no good rea­son to keep them wait­ing.”

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

The FDA on Tuesday released a warning letter sent to a Minnesota physician who failed to exclude vulnerable populations from two clinical trials comparing the anesthetic ketamine with haloperidol and midazolam as potential severe agitation treatments.

The letter makes clear that not only did Jon Cole, emergency doc at Minneapolis’ Hennepin County Medical Center, never file INDs for the trials with the FDA, as required by law, he also didn’t write appropriate protocols to ensure that children and pregnant women weren’t enrolled, and didn’t exclude those who were under the influence of intoxicants, in whom the use of ketamine is cautioned.