FDA user fee clears House; Se­nate must act be­fore Oc­to­ber

Modern Healthcare - - NEWS - By Alex Kacik

With the clock tick­ing, the House of Rep­re­sen­ta­tives last week took a ma­jor step to­ward reau­tho­riz­ing the Food and Drug Ad­min­is­tra­tion’s abil­ity to col­lect user fees from drug and de­vice mak­ers and avoid hav­ing to hand out pink slips to thou­sands of agency staffers.

The House ap­proved a bill call­ing for more than $400 mil­lion in new user fees in fis­cal 2018, with in­cre­men­tal in­creases each year there­after. It would al­low the FDA to hire more staffers and speed up ap­proval of drugs and de­vices, which could help health­care com­pa­nies stream­line op­er­a­tions, sup­port­ers ar­gue.

Yet, crit­ics claim that the ris­ing fees dis­pro­por­tion­ately af­fect smaller com­pa­nies and that ex­pe­dit­ing the re­view of drugs and med­i­cal de­vices could com­pro­mise qual­ity.

The bill in­cludes an amend­ment pro­vid­ing a six-month ex­clu­sive rights pe­riod to any generic man­u­fac­turer choos­ing to com­pete against an off-patent drug that has no com­pe­ti­tion. Cur­rently, that ex­clu­siv­ity is avail­able only to a first en­trant. Other pro­vi­sions in­clude eas­ing re­quire­ments for med­i­cal imag­ing de­vices, cre­at­ing a pi­lot project to eval­u­ate the post-mar­ket safety of med­i­cal de­vices, form­ing a new reg­u­la­tory class of hear­ing aids that could be sold over the counter and ad­just­ing the risk-based clas­si­fi­ca­tion of med­i­cal de­vices in an ef­fort to im­prove the pre­dictabil­ity of re­view pe­ri­ods.

The user-fee pro­gram must be reau­tho­rized by the end of Septem­ber or the FDA will have to lay off more than 5,000 em­ploy­ees. A de­lay also would post­pone the re­view of many drugs and de­vices.

The Se­nate Health, Ed­u­ca­tion, La­bor and Pen­sions Com­mit­tee ap­proved its ver­sion of a bill in May, but the full Se­nate has yet to take ac­tion, and the win­dow is clos­ing given an al­ready packed agenda that in­cludes re­peal­ing and re­plac­ing the Af­ford­able Care Act, ad­dress­ing the debt ceil­ing and pass­ing a bud­get. House and Se­nate ver­sions of the bill have to rec­on­ciled be­fore be­ing sent to the pres­i­dent.

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