Pharma’s spring of­fen­sive

Modern Healthcare - - COMMENT -

Dur­ing an off-year leg­isla­tive sea­son when most of the public’s at­ten­tion is al­ready fo­cused on who will suc­ceed Obama in the White House, one of the best-heeled lob­by­ing forces in the na­tion’s cap­i­tal—the phar­ma­ceu­ti­cal in­dus­try—is closing in on a set of leg­isla­tive tri­umphs that threaten to un­der­mine health­care af­ford­abil­ity at home and abroad for years to come.

The 21st Cen­tury Cures Act now march­ing through Congress would lower the bar for ap­prov­ing high-cost drugs of un­known med­i­cal util­ity. It also opens the door to more ex­ten­sive and eas­ily dis­guised phar­ma­ceu­ti­cal mar­ket­ing.

Poorly con­trolled drug mar­ket­ing poses a threat to ev­ery­one con­cerned about ris­ing health­care costs. Take, for in­stance, the ap­proval last week of two new bi­o­logic drugs that lower “bad” choles­terol lev­els more than statins, which are now generic. Those drugs could wind up cost­ing the health­care sys­tem $23 bil­lion an­nu­ally.

Though ap­proved only for peo­ple with fa­mil­ial hy­per­c­holes­terolemia (a ge­netic dis­ease), adroit mar­ket­ing could make those monthly shots a popular off-la­bel item for physi­cians con­vinced that “lower is bet­ter.” How­ever, the man­u­fac­tur­ers have yet to pro­duce clin­i­cal tri­als show­ing th­ese drugs are any bet­ter at re­duc­ing the risk of heart at­tacks and strokes than statins.

Mean­while, the Trans-Pa­cific Part­ner­ship trade bill be­ing pushed by the Obama ad­min­is­tra­tion con­tains in­tel­lec­tual prop­erty pro­vi­sions that would limit the abil­ity of de­vel­op­ing coun­tries to ac­quire generic or less-costly ver­sions of branded prod­ucts. The bill also extends clin­i­cal-trial data pro­tec­tion to 12 years, not the seven called for in Obama’s last bud­get, which would have saved $4 bil­lion over the next decade by al­low­ing ear­lier ac­cess to gener­ics.

An early ver­sion of the bill cut hos­pi­tals’ Medi­care pay­ments to off­set costs. Though that pro­vi­sion has been elim­i­nated, the fact that few on Capitol Hill ques­tion the bill’s patent or data pro­vi­sions is tes­ti­mony to the drug in­dus­try’s en­dur­ing in­flu­ence over both Repub­li­cans and Democrats in Wash­ing­ton.

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