Congress Eyes $10-M Boost for FDA's Generic Budget

Legislation that would sweeten the annual funding for the FDA's Office of Generic Drugs (OGD) by $10 million is winning support on Capitol Hill. The bill, which won approval from a Senate appropriations subcommittee before the summer congressional recess, would provide critically needed resources for the office to speed approvals of lower-cost generic drugs. The OGD's workload has increased 36% in recent years, and more than 800 applications for new generic medicines are languishing at the agency.

"Funding for [the] OGD has remained relatively flat over the past several years, and the backlog of generic drug applications has continued to grow," Generic Pharmaceutical Association (GPhA) President and Chief Executive Officer Kathleen Jaeger said. "Additional funding will better enable [the] OGD to process these applications more rapidly, and provide consumers with access to affordable generic drugs in a more timely fashion."

According to GPhA, the $10-million budget increase is miniscule, considering that eliminating the backlog of generic approvals would yield billions of dollars in savings for American consumers. Leaders at the association note that just a 1% increase in the use of generics nationwide would save $4 billion annually.