MARCH 01, 2007

The Bush Administration's budget plan for next year calls for the FDA to impose stiff new user fees on generic drug manufacturers seeking marketing approval for their new products. Although the plan would cost generic pharmaceutical companies an estimated $15.7 million annually, White House officials said the money from the fees would "enable [the] FDA to reduce review times and respond to a growing number of generic drug applications."

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

According to Jaeger, the "user fees in its 2008 budget will not bring generic medicines to consumers faster as long as brand companies are still permitted to use tactics that delay market entry."

Simply adding more FDA staff members to review applications for new generic pharmaceuticals will not have much effect if branded drug makers are allowed to continue using legal tactics to delay competition, she maintained. "If the administration's goal is to get safe, effective, and affordable generics to consumers faster, then it must work with Congress to remove existing barriers that are delaying access to generics and increasing health care costs," Jaeger said.

Specifically, the GPhA official cited the use of authorized generics to delay competition as well as the FDA's failure to establish an abbreviated approval pathway for biogenerics as factors in slowing the introduction of generics. Additionally, Jaeger blamed the increasing use of citizen petitions by brand companies 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 affordable generics to consumers faster," Jaeger said in response to the budget plan.