Congressman Robert Hurt (R-Va.) introduced legislation along with Congressman Phil Roe (R-Tenn.) that would level the playing field for generic drug user fees so that smaller manufacturers would be expected to pay fees that would reflect the relative size of their firms compared to drug company giants.
Hurt released the following statement following its introduction:
“I am proud to have introduced this legislation that addresses an important issue harming small generic drug manufacturers in Virginia’s Fifth District and across the country. The Food and Drug Administration is imposing user fees in a way that places a disproportionate burden on these small manufacturers, which create good jobs in places like Charlottesville, Virginia. The expectation that all manufacturers pay the same fees, regardless of their size, is unrealistic and should be adjusted to accommodate these smaller companies so they can continue to innovate, produce and compete. It is my hope that this bill moves swiftly through the legislative process so that these manufacturers are afforded relief in a timely manner,” Hurt said.
Smaller companies across the nation have been grappling with the one-size-fits-all fee structure that the FDA created pursuant to the Generic Drug User Fee Act. One manufacturing facility in Charlottesville, Afton Scientific, which provides pre-sterilized and packaged components such as sterile vials, has seen first-hand the effects of FDA’s unfair implementation of fees. Tom Thorpe, CEO of Afton Scientific, said, “I appreciate the recent action taken by Congressman Hurt on behalf of small generic drug manufacturers in the Fifth District and across the country and for his continued dedication to supporting small businesses as a key player in creating jobs. This amendment represents an important correction to the Generic Drug User Fee Act which now threatens our smaller and emerging drug manufacturing facilities that provide great jobs and many vital small quantity drugs.”
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