Se­nate panel to ex­am­ine pro­posed FDA cuts

Modern Healthcare - - THE WEEK AHEAD - —Vir­gil Dick­son

The White House on Tues­day will de­fend pro­posed cuts to the Food and Drug Ad­min­is­tra­tion bud­get. Physi­cians fear that the cuts will mean lax over­sight of drug ap­proval, po­ten­tially putting pa­tients at risk.

A Se­nate Ap­pro­pri­a­tions Com­mit­tee sub­com­mit­tee has sched­uled a hear­ing on Pres­i­dent Don­ald Trump’s 2018 bud­get pro­posal for the FDA, which calls for a $854 mil­lion cut, down 31% com­pared with 2017.

The pro­posal has sent a shud­der through the provider com­mu­nity. “Fi­nan­cially starv­ing the FDA se­verely ham­pers the agency’s abil­ity to pro­tect (pa­tients) from drugs that are in­ef­fec­tive at best and ac­tively harm­ful at worst,” Dr. John Meigs, pres­i­dent of the Amer­i­can Academy of Fam­ily Physi­cians, said in a state­ment re­leased in re­sponse to Trump’s bud­get.

To off­set the loss, the bud­get pro­poses a $1.3 bil­lion in­crease in user fees, paid by drug and de­vice mak­ers and used to sup­port staff that as­sesses new prod­ucts.

It’s un­clear if Repub­li­cans will seek the in­crease in user fees. Ne­go­ti­a­tions be­tween con­gres­sional staffers, in­dus­try stake­hold­ers and the FDA were al­ready pretty far along in late May when Trump re­leased his full bud­get pro­posal.

Ear­lier this year, Se­nate Repub­li­cans set an end of June dead­line to con­clude reau­tho­riza­tion of the drug and de­vice user fees and warned that fur­lough no­tices could go out as soon as July if that dead­line is missed.

Newspapers in English

Newspapers from USA

© PressReader. All rights reserved.