Sens. Cory Book­er (D-NJ) and Rand Paul (R-KY) like­ly don’t share much in com­mon when it comes to pol­i­cy views, but that didn’t stop the pair from in­tro­duc­ing a new bill this week that would al­ter the con­tro­ver­sial Right to Try Act to al­low ter­mi­nal­ly ill pa­tients to ac­cess Sched­ule I drugs af­ter a Phase I tri­al has been com­plet­ed.

Build­ing off its pre­de­ces­sor, the bill would skirt around the FDA’s ex­pand­ed ac­cess pro­gram and the DEA’s reg­u­la­tions around con­trolled sub­stances, and al­low pa­tients to po­ten­tial­ly ac­cess Sched­ule I drugs — like MD­MA and psilo­cy­bin — much more eas­i­ly, as the sen­a­tors say these drugs “have shown ex­cep­tion­al promise in treat­ing a va­ri­ety of men­tal health con­di­tions, in­clud­ing sui­ci­dal de­pres­sion, anx­i­ety, and PTSD.”

But as with Right to Try, the FDA is not the bar­ri­er that many as­sume it to be when it comes to ac­cess­ing in­ves­ti­ga­tion­al drugs. The agency signs off on more than 99% of all ex­pand­ed ac­cess re­quests it re­ceives. It al­so re­mains un­clear how many have at­tempt­ed and failed to gain ac­cess to Sched­ule I sub­stances out­side of clin­i­cal tri­als or FDA’s ex­pand­ed ac­cess pro­gram.

Al­i­son Bate­man-House

Al­i­son Bate­man-House, as­sis­tant pro­fes­sor at New York Uni­ver­si­ty and an ex­pert on ex­pand­ed ac­cess, ex­plained to End­points News how this bill builds on oth­er state ex­pan­sions of RTT leg­is­la­tion, even as any doc­tor with the ap­pro­pri­ate li­cens­ing can pre­scribe con­trolled sub­stances.

“This is not an at­tack on the FDA, but just on reg­u­la­tions in gen­er­al, as they don’t care who’s reg­u­lat­ing when it comes to bar­ri­ers to ac­cess,” Bate­man-House said.

But she said she has heard that there’s been a lot of in­ter­est from pa­tients around clin­i­cal tri­als test­ing MD­MA and psilo­cy­bin, al­though some of the larg­er play­ers in this space al­ready have ex­pand­ed ac­cess pro­grams set up.

The Wis­con­sin-based Usona In­sti­tute, for in­stance, pro­vides cGMP psilo­cy­bin for clin­i­cal stud­ies and has a process set up where­by el­i­gi­ble aca­d­e­m­ic re­searchers can ac­cess the sup­plies to ad­vance sci­en­tif­ic and med­ical un­der­stand­ing of psy­che­delics.

“Re­cent stud­ies sug­gest that MD­MA and psilo­cy­bin could rep­re­sent an enor­mous ad­vance­ment in men­tal health and psy­chophar­ma­col­o­gy,” Book­er said in a state­ment. “Un­for­tu­nate­ly, many el­i­gi­ble pa­tients who ur­gent­ly need care do not cur­rent­ly have ac­cess to these promis­ing ther­a­pies.”

Com­pan­ion leg­is­la­tion will be in­tro­duced in the House by Reps. Earl Blu­me­nauer (D-OR) and Nan­cy Mace (R-SC).

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.