FDA re­vis­es guid­ance on post­mar­ket­ing stud­ies to re­flect ARIA sys­tem, SUP­PORT act

The FDA on Thurs­day re­vised its draft guid­ance on post­mar­ket­ing stud­ies and clin­i­cal tri­als un­der Sec­tion 505(o)(3) of the Fed­er­al Food, Drug, and Cos­met­ic Act (FD&C Act).

The FDA says the draft guid­ance, first is­sued for com­ment in 2011, is be­ing re­vised to de­tail the fac­tors the agency con­sid­ers when de­ter­min­ing whether a post­mar­ket­ing study or clin­i­cal tri­al will be re­quired for a drug or bi­o­log­ic or whether post­mar­ket­ing re­ports and the agency’s ac­tive post­mar­ket risk iden­ti­fi­ca­tion and analy­sis (ARIA) sys­tem are suf­fi­cient to as­sess a prod­uct’s risks in the post­mar­ket set­ting.

The FDA ex­plains that at the time the draft guid­ance was first is­sued, “the ARIA sys­tem was still in ear­ly de­vel­op­ment” and now that it is ful­ly op­er­a­tional, it must be con­sid­ered when de­ter­min­ing if a post­mar­ket­ing study or clin­i­cal tri­al is re­quired.

The guid­ance is al­so be­ing up­dat­ed to re­flect a pro­vi­sion of the 2018 Sub­stance Use-Dis­or­der Pre­ven­tion that Pro­motes Opi­oid Re­cov­ery and Treat­ment for Pa­tients and Com­mu­ni­ties Act (SUP­PORT Act) that en­ables the FDA to re­quire post­mar­ket­ing stud­ies un­der sec­tion 505(o)(3) to as­sess the po­ten­tial re­duc­tion in ef­fi­ca­cy of a drug.

While the SUP­PORT Act fo­cus­es on opi­oids and oth­er con­trolled sub­stances, the FDA notes that “at this time, the agency does not in­tend to treat con­trolled sub­stances dif­fer­ent­ly than oth­er pre­scrip­tion drugs.”

The re­vised draft guid­ance pro­vides a list of four ex­am­ples of clin­i­cal tri­als to as­sess risks re­lat­ed to re­duced ef­fec­tive­ness; though, in line with the agency’s state­ment on not dif­fer­en­ti­at­ing be­tween con­trolled sub­stances and oth­er drugs, does not in­clude any ex­am­ples of tri­als in­volv­ing opi­oids or oth­er con­trolled sub­stances.

FDA


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