US president Barack Obama signed the Food and Drug Administration (FDA) user fee bill into law earlier this week in a move that both regulators and the pharmaceutical industry have been calling for some time.
One of the first to issue a statement was Patty Benson from SAFC who chairs SOCMA’s bulk pharmaceuticals task force - an industry trade group for manufacturers of active pharmaceutical ingredients.
Benson set the landmark law in the context of both drug quality and the health of the US pharmaceutical industry.
“For too long, the US drug supply has been susceptible to sub-par quality drugs due to the lack of FDA enforcement of basic drug quality inspections of foreign facilities.
“By signing this bipartisan, bicameral bill into law, the president has demonstrated his commitment to improving the quality of drugs entering the U.S. and encouraging domestic job production by eliminating the economic advantage of foreign manufacturing facilities.”
The Act reauthorizes user fees for drugs and devices – PDUFA V and MUDFA III – both of which were due to expire in September and introduces fee schemes for generic and biosimilar drugs – GDUFA and BsUFA.
Under GDUFA – which BPTF helped to negotiate - the generic drug industry will pay fees of around $1.5bn over five years in return for faster, more predictable review of generic drug applications
BPTF claims that this will help reduce drug shortages, bring drugs to market faster and allow the FDA to perform inspections on a risk basis, focusing on the facilities posing the greatest risk to drug safety.