ARLINGTON, Va. An organization representing the generic drug industry is hoping that Congress gives the Food and Drug Administration’s Office of Generic Drugs increased funding.
The Generic Pharmaceutical Association expressed hope that Congress would pass the Obama administration’s budget, which would give the OGD $51.5 million, $10 million more than it got last fiscal year.
“Given the critical mission of the FDA to protect the public health, it is incumbent upon Congress to provide the agency with the resources it needs to fulfill this mission,” GPhA president and CEO Kathleen Jaeger said in a statement. “There is no doubt that the FDA’s Office of Generic Drugs is severely underfunded.”
The office has hit a speed bump in recent years as its backlog of generic drug approval applications has swelled. In testimony before the Senate Agriculture Appropriations Subcommittee, FDA commissioner Margaret Hamburg said nearly 2,000 applications currently pending. Another swell of applications is on the way as patents on a number of drugs, including blockbusters such as Pfizer’s cholesterol-lowering drug Lipitor (atorvastatin) are set to expire over the next decade.
“It is unacceptable that the current review time has swelled to 26 months, nearly one and a half years longer than the six-month review period permitted under federal regulation,” Jaeger said.