Under the recommendations – which were completed and submitted to the US Congress in January – the generic drug industry would pay the Food and Drug Administration (FDA) an annual fee of $299m to fund ANDA reviews and – crucially for BPTF - facility inspections.
In a statement issued yesterday BPTF said GDUFA would “better protect the US drug supply by levelling the playing field between foreign and domestic manufacturing facilities inspected by the Food and Drug Administration (FDA).”
BPTF – which lists suppliers like BASF, DSM, Lonza, SAFC and others among its members – has played a significant part in developing the proposals as chair Patty Benson, Quality Assurance Director at SAFC, explained.
“Since 2006, BPTF has been advocating for increased resources for the FDA in order to conduct more inspections of foreign drug ingredient manufacturers,” adding that “this legislation will go a long way in safeguarding our drug supply and result in greater scrutiny of drug manufacturing in high-risk regions of the globe.”
BPTF is one of a number of organisations to reiterate its support for GDUFA since it was debated by the House Committee on Energy and Commerce in February – click here for Janet Woodcock director of the Center for Drug Evaluation and Research (CDER) at FDA testimony.