It’s well un­der­stood that racial and eth­nic mi­nori­ties of­ten lack ac­cess to clin­i­cal tri­als in the US, ei­ther be­cause of re­strict­ed in­clu­sion/ex­clu­sion cri­te­ria or be­cause they don’t have the time, in­sur­ance, in­ter­est or un­der­stand­ing of what clin­i­cal tri­als are avail­able.

But what about eth­nic and racial mi­nori­ties ac­cess­ing the FDA’s ex­pand­ed ac­cess pro­gram?

That’s what the FDA wants to know, as the agency is now propos­ing to add an op­tion­al item re­gard­ing race and eth­nic­i­ty un­der the “Clin­i­cal In­for­ma­tion/Brief Clin­i­cal His­to­ry” field in its form that physi­cians have to fill out for ex­pand­ed ac­cess re­quests for in­di­vid­ual pa­tient INDs.

The FDA’s ex­pand­ed ac­cess or “com­pas­sion­ate use” pro­gram, known as EAP, of­fers peo­ple with se­ri­ous or im­me­di­ate­ly life-threat­en­ing ill­ness­es or con­di­tions ac­cess to po­ten­tial new drugs, even if they don’t qual­i­fy for a clin­i­cal tri­al. The on­ly catch is that the drug­mak­er de­vel­op­ing the po­ten­tial drug has to OK its use out­side of a tri­al, which can be a lim­i­ta­tion to ac­cess, al­though the FDA signs off on more than 99% of all EAP re­quests.

Al­i­son Bate­man-House, an as­sis­tant pro­fes­sor at the NYU Gross­man School of Med­i­cine who stud­ies ex­pand­ed ac­cess, told End­points News that she’s en­cour­aged by this pro­pos­al from FDA to col­lect more race and eth­nic­i­ty da­ta around its EAPs as it will “goad spon­sors in­to col­lect­ing this da­ta” more fre­quent­ly.

“The ques­tion we want an­swered is are some of these mi­nori­ties who are shut out of tri­als able to be ac­com­mo­dat­ed by ex­pand­ed ac­cess, or is it the priv­i­leged few who are get­ting ac­cess to tri­als” and EAPs, she said. “My hunch is the lat­ter.”

The push from FDA comes as it has re­leased a new frame­work around how it plans to bet­ter ad­dress these racial and eth­nic dis­par­i­ties. Part of that frame­work in­cludes set­ting goals for en­roll­ment and spec­i­fy­ing re­ten­tion strate­gies, such as pro­vid­ing lan­guage as­sis­tance and re­duc­ing the bur­dens of par­tic­i­pa­tion with tools like tele­health.

“Go­ing for­ward, achiev­ing greater di­ver­si­ty will be a key fo­cus through­out the FDA to fa­cil­i­tate the de­vel­op­ment of bet­ter treat­ments and bet­ter ways to fight dis­eases that of­ten dis­pro­por­tion­ate­ly im­pact di­verse com­mu­ni­ties,” FDA com­mis­sion­er Rob Califf said in a state­ment.

More peo­ple are al­so in­ter­est­ed in ex­pand­ed ac­cess now be­cause of the pan­dem­ic, Bate­man-House said in ex­plain­ing the re­cent rise in EAPs, par­tic­u­lar­ly as for­mer Pres­i­dent Don­ald Trump used FDA pro­grams to gain ac­cess to Re­gen­eron’s mon­o­clon­al an­ti­body com­bo treat­ment.

For in­stance, CBER re­port­ed more than 6,000 sin­gle pa­tient emer­gency IND re­quests in FY 2020, com­pared with 216 in FY 2021. CDER al­so re­port­ed al­most twice as many re­quests in 2020 when com­pared to oth­er re­cent years.

“The thing we’re think­ing about is how much the struc­tur­al in­equal­i­ties in clin­i­cal tri­als are repli­cat­ed or en­hanced in ex­pand­ed ac­cess,” Bate­man-House added.

And the FDA is ex­pect­ing those high­er num­bers to con­tin­ue, not­ing in the Fed­er­al Reg­is­ter on Wednes­day that its in­for­ma­tion col­lec­tion around EAP “re­flects an in­crease in 254,750 bur­den hours and 11,568 re­spons­es an­nu­al­ly since the last OMB re­view and ap­proval of the in­for­ma­tion col­lec­tion. We at­tribute this to an in­crease in the num­ber of sub­mis­sions.”

The es­ti­mate of 254,750 hours cal­cu­lates out to about 122 new em­ploy­ees work­ing 40 hours per week for one year.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”