Se­nate panel to dis­cuss fu­ture of FDA user fees

Modern Healthcare - - THE WEEK AHEAD - —Adam Ruben­fire

The U.S. Se­nate Health, Ed­u­ca­tion, La­bor & Pen­sions Com­mit­tee will eval­u­ate the fu­ture of the fees the Food and Drug Ad­min­is­tra­tion levies on med­i­cal prod­ucts dur­ing a hear­ing Tues­day.

The hear­ing comes not long af­ter Pres­i­dent Don­ald Trump re­leased a 2018 bud­get blue­print dou­bling the $1 bil­lion in rev­enue the fees gen­er­ate, though the ad­min­is­tra­tion didn’t spec­ify what por­tion of that would come from med­i­cal de­vices ver­sus phar­ma­ceu­ti­cals, the lat­ter his­tor­i­cally gen­er­at­ing a much larger source of fee rev­enue. The fees fund ways to ex­pe­dite the FDA’s prod­uct ap­proval process and will be piv­otal to Trump’s prom­ises to re­form the agency.

The House En­ergy and Com­merce health sub­com­mit­tee hosted a hear­ing on ex­pected changes to the FDA’s Med­i­cal De­vice User Fee Ad­mend­ments pro­gram last week. The Ad­vanced Med­i­cal Tech­nol­ogy As­so­ci­a­tion, which rep­re­sents de­vice­mak­ers, is on board with the lat­est fee pack­age, which CEO Scott Whi­taker called a “win-win-win for the FDA, for in­no­va­tion and most of all, for pa­tients.”

“The reau­tho­riza­tion (of the changes) will al­low the FDA to build upon the demon­strated suc­cess of this pro­gram, and in so do­ing, fur­ther ben­e­fit pa­tients and af­firm our na­tion’s stand­ing as a global leader in bio­med­i­cal in­no­va­tion,” said Dr. Jef­frey Shuren, di­rec­tor of the FDA’s Cen­ter for De­vices and Ra­di­o­log­i­cal Health, in pre­pared tes­ti­mony.

Vince For­lenza, out­go­ing Ad­vaMed chair­man and CEO of Bec­ton, Dickinson and Co., said the pack­age is a boon for the de­vice in­dus­try and BD, specif­i­cally. “We think it’s the right bill, it has the right el­e­ments in there, and has the right fi­nan­cial struc­ture,” he said.

Crit­ics say an in­crease in fees could hurt smaller firms, in­clud­ing dig­i­tal health star­tups with smaller bud­gets.

Trump’s nom­i­nee to lead the FDA, Dr. Scott Got­tlieb, will be re­spon­si­ble for us­ing the fees to im­ple­ment per­for­mance im­prove­ment pro­grams at the agency.

As of Jan. 21, the FDA had 4,205 generic drug ap­pli­ca­tions await­ing ap­proval. Drug­mak­ers and de­vice­mak­ers alike have chas­tised the agency for hav­ing a large back­log of ap­pli­ca­tions that stymies in­no­va­tion. Trump has called the ap­proval process “slow and bur­den­some” and has vowed to “slash re­straints” on drug de­vel­op­ment.


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