SENATE FOCUSES ON BIODRUG APPROVALS

Pharmacy Times, Volume 0, 0

Efforts bygeneric drugindustry leadersto pressurethe FDAinto establishing aclear-cut abbreviatedapproval process forgeneric versions of biologicdrugs drew mixed support onCapitol Hill as the Senate HealthCommittee launched a newround of hearings on the issue.In a statement kicking off thehearings, Committee ChairmanEdward Kennedy (D, Mass) saidthat Congress has "a responsibilityto expand the horizons ofmedical science." Legislatively,"our goal...should be to enablecompanies to invest in newmedical breakthroughs, whiledoing all we can to cut costs forpatients and protect safety."

Unlike advocates of pendingbiodrug approval legislation,however, Sen Kennedy appearsto be leaning toward a moreconservative path that critics saywould sacrifice approval speedfor "excess" safety. Specifically,he favors the approach forgeneric biodrug approvals usedin Europe—a system that permitscheaper generic versions ofinsulin and other biologics toreach the market, but only aftertheir sponsors conduct lengthyand expensive clinical trials.

Critics of that approach, includingsponsors of the pendingSenate legislation and genericdrug industry leaders in theUnited States, fear that requiringsuch clinical testing would havea chilling effect on the developmentof generic biodrugs withoutproviding any correspondingincrease in safety.