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.”

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Senators on Sunday finalized the text of a massive, bipartisan infrastructure bill that contains little that might impact the biopharma industry other than two ways the legislators are planning to pay for the $1.2 trillion deal.

On the one hand, senators are seeking to further delay a Trump-era Medicare Part D rule related to drug rebates, this time until 2026. Senators claim the rule could end up saving about $49 billion, but the PBM industry has attacked it as it would remove rebates from a safe harbor that provides protection from federal anti-kickback laws. The pharmaceutical industry, however, is in favor of the rule and opposes this latest delay as it continues to point its finger at the PBM industry for the rising cost of out-of-pocket expenses.

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.