About a fourth of US adults live with some type of dis­abil­i­ty, ac­cord­ing to the CDC. On Wednes­day, Bris­tol My­ers Squibb launched a new ini­tia­tive to en­sure those pa­tients get ac­cess to clin­i­cal tri­als.

The phar­ma gi­ant is team­ing up with the non­prof­it Dis­abil­i­ty So­lu­tions to cre­ate the Dis­abil­i­ty Di­ver­si­ty in Clin­i­cal Tri­als (DDiCT) Ini­tia­tive, a pro­gram that’s ini­tial­ly fo­cus­ing on com­ing up with a set of rec­om­men­da­tions for im­prov­ing ac­cess, speed of en­roll­ment and par­tic­i­pa­tion of peo­ple with dis­abil­i­ties in tri­als.

“We col­lect da­ta around oth­er un­der­rep­re­sent­ed groups in clin­i­cal tri­als,” Julie Sowash, ex­ec­u­tive di­rec­tor of Dis­abil­i­ty So­lu­tions, told End­points News. “Peo­ple with dis­abil­i­ties are al­most al­ways ex­clud­ed from that de­mo­graph­ic col­lec­tion.”

The news comes as phar­ma com­pa­nies face mount­ing pres­sure to make clin­i­cal tri­als more in­clu­sive. A slate of phar­ma com­pa­nies has set eq­ui­ty goals, in­clud­ing Gilead, which to­day an­nounced an $85 mil­lion con­tri­bu­tion to the Gilead Foun­da­tion to sup­port health eq­ui­ty.

A re­cent re­view of stud­ies in the UK’s Na­tion­al In­sti­tute for Health and Care Re­search port­fo­lio found that 60% ex­clud­ed learn­ing dis­abil­i­ty groups — and re­searchers have not­ed sim­i­lar ex­clu­sion in the US. Ac­cord­ing to a JA­MA re­view of Phase III and IV stud­ies, ex­plic­it ex­clu­sion cri­te­ria pre­vent­ed a sig­nif­i­cant num­ber of peo­ple with in­tel­lec­tu­al, de­vel­op­men­tal or phys­i­cal dis­abil­i­ties from par­tic­i­pat­ing in tri­als.

Oth­er bar­ri­ers to par­tic­i­pa­tion in­clude in­ac­ces­si­ble tri­al sites, med­ical equip­ment and “ableist bi­as­es which de­ter this com­mu­ni­ty from re­ceiv­ing po­ten­tial­ly life-sav­ing treat­ments,” BMS said in a state­ment. Sowash cit­ed in­formed con­sent as one spe­cif­ic ex­am­ple of this.

“There are a lot of reg­u­la­tions around can a per­son with a dis­abil­i­ty con­sent, who can con­sent for them?” she said. “And we need to just see, are those med­ical­ly nec­es­sary? Are they med­ical­ly rel­e­vant to the re­search process?”

Samit Hi­rawat

The ini­tia­tive aligns with BMS’ broad­er di­ver­si­ty goals, in­clud­ing a com­mit­ment to lo­cate a quar­ter of its clin­i­cal tri­al sites in “high­ly di­verse com­mu­ni­ties” this year. It was ini­ti­at­ed by BMS’ Dis­abil­i­ty Ad­vance­ment Work­place Net­work (DAWN), and will be co-led by the com­pa­ny’s glob­al drug de­vel­op­ment team.

While Sowash hopes the ini­tia­tive will even­tu­al­ly help set a new in­dus­try stan­dard for clin­i­cal tri­al pro­to­cols, she ac­knowl­edged that they’re still in the “knowl­edge-gath­er­ing stage,” which in­volves col­lect­ing da­ta, iden­ti­fy­ing bar­ri­ers and un­der­stand­ing how to make tri­als more ac­ces­si­ble.

“We’re go­ing to start to see what those gaps and op­por­tu­ni­ties are to make what could be dra­mat­ic im­prove­ments to ac­cess for health­care for peo­ple with dis­abil­i­ties,” she said.

“Through this work, Bris­tol My­ers Squibb can set the stan­dard and stage for ac­cess to life-chang­ing and life-sav­ing med­i­cines for peo­ple with dis­abil­i­ties,” BMS CMO Samit Hi­rawat said in a state­ment. “The long-term goal of our DDiCT pro­gram is to de­vel­op and pi­lot tri­als that are ac­ces­si­ble to the widest va­ri­ety of pa­tients.”

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.