Photo: Allen G. Breed/AP Images (file)

Gener­ic abor­tion drug man­u­fac­tur­er sues West Vir­ginia over re­stric­tions

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.

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.

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