FDA commissioner Rob Califf (Michael Brochstein/Sipa USA/Sipa via AP Images)

FDA com­mis­sion­er spells out agen­cy's top pri­or­i­ties, with a fo­cus on dis­pelling mis­in­for­ma­tion

It’s been a lit­tle more than six months since FDA com­mis­sion­er Rob Califf won Sen­ate con­fir­ma­tion, and while he high­light­ed some of his key goals ear­ly on, he of­fered the agency’s lat­est ar­ray of top pri­or­i­ties in a JA­MA view­point yes­ter­day af­ter­noon.

At the top of the list, even as gen­er­al fa­tigue has tak­en hold among the pub­lic’s per­cep­tion to­ward the pan­dem­ic, is Covid-19, and the on­go­ing opi­oid ad­dic­tion cri­sis, which took more than 100,000 lives in 2021.

Califf, who has gen­er­al­ly avoid­ed the spot­light since tak­ing over FDA, notes that both the Covid-re­lat­ed and opi­oid-re­lat­ed death rates in the US are too high, and the US trails high-in­come coun­tries on Covid-re­lat­ed vac­ci­na­tion and death rates, adding:

The clin­i­cal com­mu­ni­ty must re­main re­silient and work to­ward more eq­ui­table de­liv­ery of ev­i­dence-based ther­a­pies. Sub­stan­tial dis­par­i­ties in COVID-19 vac­ci­na­tion rates and use of ther­a­peu­tics will be closed on­ly with a proac­tive ap­proach by clin­i­cians. Fur­ther­more, the US pub­lic has been ex­posed to high­ly vari­able rec­om­men­da­tions on so­cial me­dia and in pro­fes­sion­al cir­cles about COVID-19 treat­ment and pre­ven­tion. Broad col­lab­o­ra­tion is need­ed across clin­i­cal com­mu­ni­ties to pro­mote re­li­able in­for­ma­tion about life­sav­ing vac­ci­na­tions and treat­ments and counter the spread of med­ical mis­in­for­ma­tion.

This fo­cus on com­bat­ing mis­in­for­ma­tion is on full dis­play with the FDA’s re­cent­ly launched web­page on “Ru­mor Con­trol,” which raised a few eye­brows as any gov­ern­ment web­page at­tempt­ing to con­trol a sto­ry­line would. Mes­sag­ing like, “Don’t be­lieve the ru­mors,” may even end up be­ing coun­ter­in­tu­itive and dif­fi­cult for the gen­er­al pub­lic to un­der­stand in con­text if the FDA isn’t dis­put­ing par­tic­u­lar ru­mors be­yond the four list­ed.”

An­oth­er ma­jor pri­or­i­ty fo­cus Califf points to is around “ev­i­dence gen­er­a­tion,” a top­ic that’s been a part of his ca­reer from the be­gin­ning as one of the na­tion’s top clin­i­cal tri­al ex­perts.

“When the FDA’s de­ci­sions gen­er­ate con­tro­ver­sy, it is of­ten when the sys­tem fails to pro­duce re­li­able ev­i­dence that clar­i­fies an in­ter­ven­tion’s risks and ben­e­fits dur­ing a rel­e­vant time frame,” he ex­plains. “The gap be­tween FDA clear­ance or ap­proval of a med­ical prod­uct (par­tic­u­lar­ly when the ac­cel­er­at­ed ap­proval path­way is used) and use of the prod­uct to treat pa­tients should be filled by an in­vig­o­rat­ed clin­i­cal re­search sys­tem that gen­er­ates ev­i­dence that pa­tients, clin­i­cians, and health sys­tems need to make well-in­formed de­ci­sions.”

Last month, Califf al­so made clear that his sec­ond stint as FDA com­mis­sion­er will em­brace new da­ta, per­haps harken­ing back to his re­cent work with Google’s par­ent com­pa­ny Al­pha­bet, where he led the firm’s pol­i­cy work.

“Our de­liv­ery of ev­i­dence to sup­port de­ci­sion mak­ing is a frac­tion of what it ought to be giv­en the tech­no­log­i­cal ex­per­tise that we have glob­al­ly and in the Unit­ed States,” Califf said at an Al­liance for a Stronger FDA event. “When the ev­i­dence is good, we still have our ar­gu­ments about how to in­ter­pret it, but it’s en­tire­ly dif­fer­ent when the FDA has to make a de­ci­sion by a user-fee man­dat­ed day, and the ev­i­dence is not en­tire­ly clear, and a de­ci­sion is still need­ed.”

Con­tin­u­ing Califf’s in­ter­est in push­ing FDA de­ci­sion-mak­ing fur­ther in­to the space of re­al-world ev­i­dence, he ex­plains how “[i]nno­v­a­tive us­es of da­ta can re­fine cur­rent ap­proach­es to iden­ti­fy­ing dif­fer­ences in health out­comes across the pop­u­la­tion and in­form nec­es­sary in­ter­ven­tions to im­prove out­comes for all. In­equities as­so­ci­at­ed with race and eth­nic­i­ty, age, sex, gen­der, and so­cioe­co­nom­ic fac­tors are read­i­ly ap­par­ent through the lens of geospa­tial da­ta.”

And while the dig­i­tal da­ta ecosys­tem has helped to pro­pel ac­cu­rate di­ag­noses, it hasn’t done enough to close cer­tain eq­ui­ty gaps, and it’s “been con­t­a­m­i­nat­ed by mis­in­for­ma­tion and dis­in­for­ma­tion,” he adds, call­ing on FDA again to be “more proac­tive in pre­empt­ing and coun­ter­ing mis­in­for­ma­tion.”

While FDA is fo­cused on im­prov­ing clin­i­cal tri­al di­ver­si­ty, Califf said that un­less da­ta shar­ing im­proves, “these so­lu­tions will fall short of their po­ten­tial.”

On opi­oids, he al­so notes how the prob­lem “has been wors­ened by easy ac­cess to po­tent, low-cost fen­tanyl and metham­phet­a­mine syn­the­sized on large scales in il­lic­it fac­to­ries and dis­trib­uted via re­fined sys­tems. The FDA will re­dou­ble ef­forts to en­hance ac­cess to nalox­one, im­prove pre­scriber ed­u­ca­tion, and en­cour­age de­vel­op­ment of new ther­a­pies for pain and sub­stance use dis­or­ders.”

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