Tar­get: Drug short­ages

User-fee bill ad­dresses pre­scrip­tion dis­rup­tions

Modern Healthcare - - THE WEEK IN HEALTHCARE - Rich Daly

A Se­nate-passed mea­sure to re­new ex­pir­ing user-fee pro­grams for drug and de­vice man­u­fac­tur­ers also would ad­dress the grow­ing con­cern over drug short­ages. The House of Rep­re­sen­ta­tives was ex­pected to con­sider its user-fee mea­sure on Wed­nes­day.

The bill reau­tho­riz­ing the Food and Drug Ad­min­is­tra­tion’s user-fee pro­grams and cre­at­ing new generic and biosim­i­lar user-fee pro­grams passed the Se­nate 96-1 on May 24. The pro­grams are in­tended to im­prove, ex­pe­dite and help pay for prod­uct re­views.

The bill in­cludes sev­eral ini­tia­tives aimed at re­liev­ing pre­scrip­tion drug short­ages. It would re­quire man­u­fac­tur­ers to pro­vide ex­panded no­ti­fi­ca­tion to HHS of po­ten­tial short­ages or dis­rup­tions and give the FDA au­thor­ity to ex­pe­dite drug re­views aimed at mit­i­gat­ing the ef­fects of a short­age. It also would al­low reg­u­la­tors to con­duct ex­pe­dited in­spec­tions of fa­cil­i­ties that could help pre­vent a short­age and es­tab­lish an Hhs-led task force to mit­i­gate and pre­vent short­ages through public-pri­vate co­or­di­na­tion and plan­ning.

“This plan would en­sure FDA pri­or­i­tizes drug short­age con­cerns, en­hance FDA’S knowl­edge of po­ten­tial drug short­ages be­fore they hap­pen and give them the tools to ad­dress and mit­i­gate them when they arise,” Sen. Michael Ben­net (D-colo.) said in a

writ­ten state­ment.

Such short­ages force providers to choose be­tween pre­scrib­ing pro­hib­i­tively ex­pen­sive drugs or uti­liz­ing drugs from “non­tra­di­tional” sources that do not re­li­ably pro­vide safe and ef­fec­tive med­i­ca­tions, said sup­port­ers of the bill. For in­stance, an Au­gust 2011 study by Premier health­care al­liance found that dur­ing mas­sive drug short­ages, providers faced price goug­ing at­tempts by “gray mar­ket” ven­dors of­fer­ing short­age drugs at an av­er­age of 650% their nor­mal cost.

“A record num­ber of drug short­ages has had an ad­verse ef­fect on public health and safety, and is a con­tribut­ing fac­tor to ris­ing health­care costs,” Blair Childs, se­nior vice pres­i­dent of public af­fairs for Premier, said in a writ­ten state­ment is­sued af­ter the Se­nate vote. “Given the sever­ity of the is­sue, we be­lieve re­quir­ing drug com­pa­nies to pro­vide early no­ti­fi­ca­tion of an­tic­i­pated short­ages to the FDA is es­sen­tial.”

An­other pro­vi­sion re­quires the FDA to fully im­ple­ment a unique de­vice iden­ti­fi­ca­tion sys­tem for med­i­cal de­vices. The UDI sys­tem was orig­i­nally re­quired in the 2007 it­er­a­tion of the user fee reau­tho­riza­tion but im­ple­ment­ing reg­u­la­tions were never is­sued. Some provider ad­vo­cates said the med­i­cal de­vice iden­ti­fier pro­gram is nec­es­sary to track down flawed prod­ucts and mit­i­gate the harm to pa­tients.

The bill also ad­dressed the in­creas­ing in­ci­dence of coun­ter­feit drugs ap­pear­ing in the U.S. phar­ma­ceu­ti­cal sup­ply by adding penal­ties for in­ten­tion­ally coun­ter­feit­ing drug prod­ucts. Drug coun­ter­feit­ing penal­ties cur­rently are the same as those im­posed for the cre­ation and sale of any other false prod­uct.

“Il­le­gal coun­ter­feit drugs are a multi­bil­lion­dol­lar global in­dus­try that’s grow­ing at an alarm­ing pace, es­pe­cially on­line, so there’s no time to waste in cre­at­ing an ef­fec­tive de­ter­rent and mak­ing cer­tain that jus­tice is served with mean­ing­ful penal­ties,” Sen. Chuck Grass­ley (R-iowa) said in a writ­ten state­ment.

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