With the FDA run­ning out of funds, health­care groups warn that the drug ap­proval process will soon be de­railed

The longest ever US gov­ern­ment shut­down has forced the FDA to fur­lough work­ers and hun­ker down around key tasks. But with cash run­ning out and their hands tied on gath­er­ing new fees, the agency is on the verge of see­ing its work on new drug ap­provals be­gin to grind to a halt. And a host of promi­nent health­care groups — in­clud­ing some well known sci­en­tif­ic or­ga­ni­za­tions — are warn­ing that the shut­down now threat­ens the na­tion’s ac­cess to cru­cial new ther­a­pies.

In a let­ter to Pres­i­dent Trump, Speak­er Nan­cy Pelosi and oth­er law­mak­ers on Tues­day, 46 ad­vo­ca­cy or­ga­ni­za­tions and pro­fes­sion­al so­ci­eties called for an end to the shut­down and asked that the FDA re­turn to full ca­pac­i­ty be­cause the health of Amer­i­cans is at stake.

“(W)e fear that this con­tin­ued shut­down not on­ly puts the cur­rent health and safe­ty of Amer­i­cans at risk, but has be­gun to put fu­ture sci­en­tif­ic dis­cov­ery and in­no­va­tion in jeop­ardy,” they wrote. “The on­go­ing gov­ern­ment shut­down forces the FDA to make dif­fi­cult choic­es re­gard­ing to which es­sen­tial func­tions its great­ly re­duced re­sources are di­rect­ed. These are de­ci­sions that nev­er should have to be made — the health and safe­ty of Amer­i­cans to­day should nev­er be weighed against the prospect of new life-sav­ing ther­a­pies for pa­tients…”

“While we ap­plaud Com­mis­sion­er Got­tlieb, FDA lead­er­ship, and ‘es­sen­tial staff’ for tru­ly hero­ic work to keep many as­pects of its mis­sion func­tion­ing, we fear that this con­tin­ued shut­down not on­ly puts the cur­rent health and safe­ty of Amer­i­cans at risk, but has be­gun to put fu­ture sci­en­tif­ic dis­cov­ery and in­no­va­tion in jeop­ardy.”

The group in­cludes AS­CO and the Na­tion­al Or­ga­ni­za­tion for Rare Dis­eases, which play a role in fo­cus­ing at­ten­tion on im­por­tant new sci­en­tif­ic de­vel­op­ments in their re­spec­tive fields.

Ex­perts sug­gest the FDA has rough­ly 2 to 3 months of fund­ing on the de­vice side. The drug side is less flush, with about a month of fund­ing left. Sub­mis­sions made pri­or to the shut­down on De­cem­ber 22 will be dealt with as usu­al, while sub­mis­sions made af­ter that date are placed in queue and will like­ly not be worked on un­til the shut­down is re­solved, ac­cord­ing to Jef­feries an­a­lysts, who added that if the shut­down con­tin­ues be­yond a month from now, the FDA will on­ly be able to fo­cus on es­sen­tial mat­ters such as food/prod­uct/man­u­fac­tur­ing safe­ty and pri­or­i­ty re­view.

Over the past few years, the FDA has grown in­creas­ing­ly pop­u­lar with bio­phar­ma com­pa­nies, which have en­joyed the most re­spon­sive agency they’ve ever known. The fo­cus un­der Scott Got­tlieb has been on ac­cel­er­at­ed ap­provals and rapid re­sponse to hur­ry along new drugs from es­tab­lished com­pa­nies. And all of that is be­ing jeop­ar­dized by the shut­down af­ter a pe­ri­od of climb­ing pro­duc­tiv­i­ty and record drug ap­provals.

If the shut­down con­tin­ues for the fore­see­able fu­ture, “the agency will have some al­go­rithm of how they go through the queue with drugs/agents with pri­or­i­ty re­view and/or oth­er high need tak­ing pri­or­i­ty…our es­ti­mate is a PDU­FA could get de­layed by per­haps the length of time from when funds dry up (next month) to when the gov­ern­ment is back open,” Jef­feries an­a­lysts said.

A sep­a­rate let­ter from more than 280 or­ga­ni­za­tions rep­re­sent­ing health, the en­vi­ron­ment, doc­tors and pa­tients al­so urged Pres­i­dent Trump last week to re­open the gov­ern­ment.

“Sev­er­al agen­cies’ abil­i­ty to pro­vide crit­i­cal ser­vices, rang­ing from food and en­vi­ron­men­tal risk in­spec­tions to health ser­vices, have al­ready been dras­ti­cal­ly re­duced or are threat­ened if the shut­down con­tin­ues. We fear a pro­longed shut­down will cause need­less suf­fer­ing and have long-last­ing health con­se­quences,” they wrote.

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