Pharmacy Times, Volume 0, 0

The Bush Administration'sbudget plan for next yearcalls for the FDA to imposestiff new user fees on genericdrug manufacturers seekingmarketing approval fortheir new products. Althoughthe plan would cost generic pharmaceutical companies an estimated$15.7 million annually, White House officials said themoney from the fees would "enable [the] FDA to reduce reviewtimes and respond to a growing number of generic drug applications."

Although user fees imposed on branded pharmaceuticalcompanies have helped to speed FDA approvals for those drugs,industry leaders are not convinced that this approach will workas well for generics. Generic Pharmaceutical Association (GPhA)President and Chief Executive Officer Kathleen Jaeger said thatthe administration's plan for user fees is "not the magic bulletfor speeding up drug approvals."

According to Jaeger, the "user fees in its 2008 budget will notbring generic medicines to consumers faster as long as brand companiesare still permitted to use tactics that delay market entry."

Simply adding more FDA staff members to review applicationsfor new generic pharmaceuticals will not have much effectif branded drug makers are allowed to continue using legal tacticsto delay competition, she maintained. "If the administration'sgoal is to get safe, effective, and affordable generics toconsumers faster, then it must work with Congress to removeexisting barriers that are delaying access to generics andincreasing health care costs," Jaeger said.

Specifically, the GPhA official cited the use of authorizedgenerics to delay competition as well as the FDA's failure toestablish an abbreviated approval pathway for biogenerics asfactors in slowing the introduction of generics. Additionally,Jaeger blamed the increasing use of citizen petitions by brandcompanies for stifling patient access to generics.

GPhA officials are not rejecting user fees out of hand, however."GPhA is open to discussing options that get affordablegenerics to consumers faster," Jaeger said in response to thebudget plan.