Risky-drugs list in the spot­light

Health­care groups, drug­mak­ers push for changes to im­prove safety

Modern Healthcare - - The Week In Healthcare - Shawn Rhea

n a rare show of unity, health­care pro­fes­sion­als, pa­tient groups and drug man­u­fac­tur­ers are voic­ing con­cern over the grow­ing list of drug-safety re­quire­ments is­sued un­der the Food and Drug Ad­min­is­tra­tion’s Risk Eval­u­a­tion and Mit­i­ga­tion Strate­gies, or REMS, pro­gram.

Dur­ing a re­cent FDA two-day pub­lic hear­ing, the groups agreed that the pro­gram is needed to al­low some ben­e­fi­cial yet risky drugs to en­ter or re­main on the mar­ket. But they also said the safety re­quire­ments are prov­ing to be un­nec­es­sar­ily con­fus­ing and in some cases too bur­den­some to physi­cians, pa­tients and man­u­fac­tur­ers.

The groups are push­ing the FDA to make sig­nif­i­cant changes to how REMS plans are de­vel­oped.

“Eval­u­a­tion of ex­ist­ing REMS is ur­gently needed to de­ter­mine if they in­deed im­prove pa­tient safety with­out un­duly bur­den­ing the health­care sys­tem and im­pair­ing pa­tient ac­cess,” said Amer­i­can Med­i­cal As­so­ci­a­tion Chair Ardis Hoven in writ­ten state­ment to Health­care.

The roughly 3-year-old REMS pro­gram was es­tab­lished as a part of the 2007 Food and Drug Ad­min­is­tra­tion Amend­ments Act. The law re­quires the FDA to de­ter­mine whether a risk-man­age­ment plan is nec­es­sary to en­sure safe use of a new drug or an al­ready mar­keted drug when post-mar­ket sur­veil­lance or re­search iden­ti­fies new safety con­cerns.

If a drug is de­ter­mined to need a REMS plan, man­u­fac­tur­ers are re­quired to con­struct med­i­ca­tion guides that de­tail the drug’s risks and in some cases pro­duce and monitor an el­e­ments-to-en­sure-safe-use plan. Those plans can in­clude physi­cian cer­ti­fi­ca­tion man­dates, pre­scrip­tion lim­its, and pa­tient coun­sel­ing and registry re­quire­ments.

FDA of­fi­cials have re­quired REMS plans for 110 med­i­ca­tions since March 2008. The list in­cludes fre­quently pre­scribed medicines such as the ane­mia drug Pr­o­crit, the asthma drug

IMod­ern Ad­vair and the fi­bromyal­gia drug Lyrica.

To date, 68% of REMS man­dates have re­quired only that man­u­fac­tur­ers cre­ate new med­i­ca­tion guides, while less than 10% have re­quired devel­op­ment and im­ple­men­ta­tion of the more re­source-in­tense el­e­ments-to-en­sure­safe-use plans. Both types of plans, how­ever, have elicited con­cerns from stake­hold­ers.

Man­u­fac­tur­ers and phar­ma­cists say the cur­rent med­i­ca­tion-guide re­quire­ments re­sult in du­pli­cate devel­op­ment and dis­tri­bu­tion of the guides to pa­tients, and that the process can cause con­fu­sion over a med­i­ca­tion’s ac­tual risks and care chal­lenges for providers.

“Phar­ma­cists and providers are say­ing that the pro­lif­er­a­tion of med­i­ca­tion guides is a bur­den and that the guides aren’t eas­ily pulled up” on elec­tronic health-record sys­tems, said An­drew Em­mett, di­rec­tor of sci­ence and reg­u­la­tory af­fairs for the Biotech­nol­ogy In­dus­try Or­ga­ni­za­tion, a drugmaker lob­by­ing group.

Bill Vaughan, se­nior health pol­icy an­a­lyst for Con­sumers Union, stopped short of call­ing REMS med­i­ca­tion-guide re­quire­ments bur­den­some but agreed that the cur­rent sys­tem is prob­lem­atic for pa­tients.

“We def­i­nitely need a sim­pli­fied, sin­gle­la­bel­ing sys­tem that peo­ple can un­der­stand,” Vaughan said. He noted that un­der the cur­rent sys­tem, a sin­gle med­i­ca­tion with a REMS re­quire­ment can have mul­ti­ple-user guides that are con­fus­ing to both pa­tients and doc­tors. “The con­tin­ued heavy pre­scrip­tion of cer­tain black-box la­bel drugs for which much safer al­ter­na­tives are avail­able raises ques­tions as to whether even pre­scribers fully un­der­stand or ap­pre­ci­ate such writ­ten warn­ing ma­te­ri­als.”

Providers said they too are un­sat­is­fied with the cur­rent REMS sys­tem, chiefly be­cause they have been ex­cluded from lend­ing ad­vice on the de­sign of man­u­fac­tur­ers’ el­e­ments-to-en­sure-safeuse plans, which can re­quire that doc­tors re­ceive drug­mak­erde­signed cer­ti­fi­ca­tion to pre­scribe cer­tain drugs and that pa­tients un­dergo spe­cific lab­o­ra­tory tests be­fore re­ceiv­ing a pre­scrip­tion.

“Cur­rently, the FDA con­sults with man­u­fac­tur­ers but not physi­cians,” noted Michael Maves, ex­ec­u­tive vice pres­i­dent and CEO of the Amer­i­can Med­i­cal As­so­ci­a­tion, in a May 2010 com­ment let­ter to the FDA. “Man­u­fac­tur­ers de­velop pro­posed REMS but are not re­quired to con­sult with physi­cians. The fore­go­ing is deeply per­plex­ing.”

Kaiser Per­ma­nente of­fi­cials voiced sim­i­lar con­cerns in com­ments to the FDA in De­cem­ber 2009. The group warned that the cur­rent REMS sys­tem has the ef­fect of cre­at­ing “a sep­a­rate cat­e­gory of drugs” and that it will re­quire “con­sid­er­ably more la­bor” from providers to de­liver cer­tain drugs to pa­tients who need them. Kaiser of­fi­cials also expressed con­cern that some drug­mak­ers may be us­ing REMS cer­ti­fi­ca­tion and mon­i­tor­ing re­quire­ments as an ex­cuse to limit their dis­tri­bu­tion of spe­cific drugs to con­tracted spe­cialty phar­ma­cies, thereby driv­ing up prices.

Kaiser and other providers are en­cour­ag­ing the FDA to es­tab­lish a stake­holder ad­vi­sory com­mit­tee, which would make REMS stan­dards rec­om­men­da­tions that would be used by drug­mak­ers to mit­i­gate risks when such ac­tions are re­quired.

No date has been set for the pub­li­ca­tion of pro­posed new draft guid­ance, but the FDA, ac­cord­ing to a Fed­eral Reg­is­ter no­tice, is ac­cept­ing com­ments un­til Aug. 31 on sug­gested changes to its REMS pro­gram.

Ad­vair, the pop­u­lar asthma drug, is one of the 110 med­i­ca­tions on the FDA’s Risk Eval­u­a­tion and Mit­i­ga­tion Strate­gies list.

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