21st Cen­tury Cures Act would lower ‘safety stan­dards,’ Ham­burg warns

Modern Healthcare - - LATE NEWS - —Vir­gil Dick­son

WASH­ING­TON—Out­go­ing Food and Drug Ad­min­is­tra­tion Com­mis­sioner Dr. Mar­garet Ham­burg, in what was likely her fi­nal public ad­dress as com­mis­sioner last Fri­day, raised se­ri­ous con­cerns about pos­si­ble pa­tient harm that could oc­cur as the re­sult of the 21st Cen­tury Cures Act now cir­cu­lat­ing on Capitol Hill.

The 393-page bill, re­leased in draft form Jan. 27, would, if en­acted, have wide-rang­ing im­pacts, in­clud­ing speed­ing up the ap­proval path­way for med­i­cal tech­nolo­gies and drugs, in part, by al­low­ing for more “flex­i­ble” clin­i­cal trial de­sign.

“There’s a mis­per­cep­tion that you might be able to speed up in­no­va­tion by low­er­ing the stan­dards for safety and ef­fi­cacy, and I think that would be a ter­ri­ble mis­take that would not only just dam­age pa­tients, but in­dus­try as well,” Ham­burg said at a Na­tional Press Club lun­cheon. The of­ten cash­strapped agency also has con­cerns that en­act­ment of the law will spread its al­ready thin re­sources even thin­ner.

“We are con­cerned through this process that we might be ... asked to take on new tasks (and) that we wouldn’t have the ad­e­quate re­sources to do them,” Ham­burg said. “This would have rip­ple ef­fects on other im­por­tant reg­u­la­tory ac­tiv­i­ties that re­ally mat­ter to pa­tients and con­sumers.”

Ham­burg has been lead­ing the FDA for the past six years and is step­ping down at the end of the month.

“As I look for­ward, I worry,” she said. “FDA has con­stantly been un­der­funded with re­spon­si­bil­i­ties that out­strip the re­sources we get to do our job.”

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