Tim­o­thy Bax­ter, who was sen­tenced last De­cem­ber to six months home de­ten­tion and fined $100,000 for send­ing false and mis­lead­ing in­for­ma­tion on the opi­oid ad­dic­tion drug Sub­ox­one, is now seek­ing to de­bate the FDA’s pro­pos­al to de­bar him.

Bax­ter, the for­mer med­ical di­rec­tor of In­di­v­ior, pre­vi­ous­ly ad­mit­ted that he failed to pre­vent In­di­v­ior from send­ing false and mis­lead­ing in­for­ma­tion to the Mass­a­chu­setts Med­ic­aid pro­gram on the rel­a­tive safe­ty of a film ver­sion of Sub­ox­one for chil­dren.

But now in re­sponse to the FDA’s pro­pos­al to de­bar Bax­ter for five years from work­ing in the in­dus­try, Bax­ter’s lawyers are re­quest­ing a hear­ing on “dis­put­ed is­sues of ma­te­r­i­al fact.”

For in­stance, Bax­ter’s lawyers say Bax­ter didn’t send the mis­lead­ing in­for­ma­tion but was su­per­vis­ing some­one who re­layed the mis­lead­ing in­for­ma­tion to the Mass­a­chu­setts Med­ic­aid pro­gram.

“Dr. Bax­ter’s con­vic­tion was not premised on the pro­vi­sion of mis­lead­ing in­for­ma­tion about the ‘rate of un­in­tend­ed pe­di­atric ex­po­sures to Sub­ox­one Film’ – the mis­lead­ing in­for­ma­tion per­tained to oth­er med­ica­tions,” the lawyers wrote.

They al­so claim that the FDA and CDC have con­clud­ed that Sub­ox­one Film is as­so­ci­at­ed with a low­er rate of pe­di­atric ex­po­sure than com­pa­ra­ble drugs.

But El­ton Mal­one, as­sis­tant in­spec­tor gen­er­al for in­ves­ti­ga­tions with­in HHS, said at the time of his sen­tenc­ing, “Bax­ter’s know­ing false and mis­lead­ing rep­re­sen­ta­tion of Sub­ox­one is no small is­sue— es­pe­cial­ly at a time when our coun­try bat­tles the on­go­ing opi­oid cri­sis.”

In ad­di­tion to the $1.4 bil­lion res­o­lu­tion with In­di­v­ior’s for­mer par­ent com­pa­ny, Reckitt Benckiser, from 2019, and a plea agree­ment with In­di­v­ior for­mer CEO Shaun Thax­ter, the to­tal res­o­lu­tion re­lat­ing to the mar­ket­ing of Sub­ox­one is more than $2 bil­lion — the largest-ever res­o­lu­tion in a case brought by the De­part­ment of Jus­tice in­volv­ing an opi­oid drug.

Bluebird bio was hit with a patent infringement lawsuit last week from a Chicago-based biotech it has had an ongoing beef with calling for $2 billion to help cure the “irreparable harm” caused by alleged willful infringement.

Bluebird bio is facing a lawsuit from Errant Gene Therapeutics for violating patent law in two instances, the company says.

The suit alleges that bluebird infringed the rights of EGT’s recombinant vectors used in the gene therapy treatment of rare diseases such as sickle cell disease and beta thalassemia for its drugs Zynteglo and LentiGlobin. EGT has an exclusive license from the Memorial Sloan Kettering Cancer Center to patents titled “vector encoding human global gene and use thereof in treatment of Hemoglobinopathies.”

It’s been a month since the FDA cleared the first biosimilar to Roche’s blockbuster wet age-related macular degeneration (AMD) drug ranibizumab. But the pharma giant isn’t going down without a fight.

Roche’s Genentech got approval on Friday for a new ranibizumab administration route that will allow wet AMD patients to ditch their current monthly injections and opt instead for as few as twice-annual treatments.