One of the gener­ic man­u­fac­tur­ers of a drug used to end ear­ly preg­nan­cies sued West Vir­ginia’s at­tor­ney gen­er­al to­day, claim­ing that fed­er­al law and the FDA’s reg­u­la­tions su­per­sede West Vir­ginia’s law ban­ning the drug.

The case will like­ly be close­ly fol­lowed, giv­en the fact that med­ica­tion abor­tions are now the ma­jor­i­ty of all abor­tions, and as the Supreme Court last Sep­tem­ber re­voked the right to abor­tion, paving the way for bans in al­most all cas­es. And if West Vir­ginia’s re­stric­tions are over­turned, as Gen­Bio­Pro claims they “func­tion­al­ly dis­place FDA’s judg­ment in ap­prov­ing mifepri­s­tone and im­pos­ing a REMS,” this might be a test case for oth­er states.

These law­suits are su­per im­por­tant bc they could re­store ac­cess to med­ica­tion abor­tion na­tion­wide, even in states with bans. But they come against the back­drop of a law­suit in TX try­ing to re­move mife from the mar­ket na­tion­wide, filed be­fore a con­ser­v­a­tive ide­o­logue judge.

— Greer Don­ley (@Greer­Don­ley) Jan­u­ary 25, 2023

But the suit notes that even be­fore Roe v. Wade was over­turned, West Vir­ginia had re­stric­tions around the use of mifepri­s­tone, in­clud­ing a wait­ing pe­ri­od re­quire­ment be­fore ob­tain­ing it, and a pro­hi­bi­tion on ob­tain­ing it via telemed­i­cine.

“Fed­er­al law pre­empts West Vir­ginia’s Ban and Re­stric­tions,” the gener­ic drug com­pa­ny Gen­Bio­Pro wrote in its suit in West Vir­ginia dis­trict court Wednes­day. “These laws im­per­mis­si­bly re­strict pa­tients’ ac­cess to mifepri­s­tone and Gen­Bio­Pro’s op­por­tu­ni­ty and abil­i­ty to mar­ket, pro­mote, and sell the med­ica­tion in the State.”

The com­pa­ny al­so makes clear that Con­gress au­tho­rized the FDA, and on­ly the FDA, to im­pose its re­stric­tions on ac­cess to mifepri­s­tone.

“West Vir­ginia can­not over­ride FDA’s de­ter­mi­na­tions about the ap­pro­pri­ate re­stric­tions on a med­ica­tion that FDA ap­proved for use and Con­gress sub­ject­ed to this en­hanced reg­u­la­to­ry regime,” they added.

Ear­li­er this month, the FDA an­nounced that cer­tain phar­ma­cies could be­gin dis­pens­ing mifepri­s­tone. Af­ter con­duct­ing a “com­pre­hen­sive re­view” of mifepri­s­tone’s risk eval­u­a­tion and mit­i­ga­tion strat­e­gy (REMS) — which pre­vi­ous­ly re­quired pa­tients to re­ceive the drug in a clin­ic, med­ical of­fice or hos­pi­tal — the agency ap­proved a mod­i­fi­ca­tion that per­mits cer­ti­fied phar­ma­cies to sell Dan­co Lab­o­ra­to­ries’ brand-name Mifeprex pills and the gener­ic man­u­fac­tured by Gen­Bio­Pro.

Gen­Bio­Pro’s suit al­so al­leges that West Vir­ginia law vi­o­lates the Com­merce Clause “by pre­vent­ing providers from pre­scrib­ing mifepri­s­tone via telemed­i­cine,” mean­ing that pa­tients are re­quired to vis­it a health­care pro­fes­sion­al in per­son to ob­tain a pre­scrip­tion.

Since 2019, when it first won ap­proval for its gener­ic mifepri­s­tone, Gen­Bio­Pro said it has mar­ket­ed and sold ap­prox­i­mate­ly 850,000 units of the drug.

Mean­while, pre­vi­ous phar­ma com­pa­nies have chal­lenged state bans on cer­tain drugs, like with the pow­er­ful opi­oid Zo­hy­dro in Mass­a­chu­setts in 2014, and won in court.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.