FDA seeks to stan­dard­ize med­i­ca­tion in­for­ma­tion

Modern Healthcare - - THE WEEK AHEAD - —Vir­gil Dick­son

When pa­tients fill a pre­scrip­tion, they some­times re­ceive mul­ti­ple in­struc­tions de­vel­oped by dif­fer­ent sources that may be du­plica­tive, in­com­plete or dif­fi­cult to read.

The Food and Drug Ad­min­is­tra­tion has been work­ing on de­vel­op­ing reg­u­la­tions that would re­quire a sin­gle doc­u­ment for pre­scrip­tion drugs known as pa­tient med­i­ca­tion in­for­ma­tion. This week, the Brook­ings In­sti­tu­tion in Wash­ing­ton will con­vene a pub­lic meet­ing in which the FDA and pri­vate sec­tor play­ers will weigh in on the prospects for mak­ing PMI a re­al­ity.

Drug-safety ad­vo­cates have long pushed for a sin­gle, clear la­bel that tells when and how a drug should be used and pro­vides clear side ef­fect warn­ings and other use­ful in­for­ma­tion.

The meet­ing takes place against a back­drop of height­ened con­cern about the di­rec­tion of FDA drug-la­bel­ing pol­icy. The agency faces crit­i­cism from some law­mak­ers and generic- drug mak­ers for a pro­posed rule re­quir­ing generic-drug com­pa­nies to up­date prod­uct la­bels if they re­ceive new safety in­for­ma­tion. Generic com­pa­nies cur­rently do not have to make such changes un­less the com­pany that de­vel­oped the orig­i­nal ver­sion of the prod­uct does so first (See p. 20).

The FDA be­lieves the rule will make it eas­ier for generic drug com­pa­nies to pass on safety in­for­ma­tion. Generic man­u­fac­tur­ers claim it will open them to prod­uct li­a­bil­ity law­suits and raise the prod­uct costs.

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