The Act, which was initiated by US president Barack Obama, enables all drug manufacturers to meet FDA’s inspection standards and improve timely access to affordable generic drugs.
Mylan CEO Heather Bresch said the company applauds the extraordinary efforts of the many in Congress who helped craft and pass the vital law in a bipartisan fashion.
"We believe these important updates to the 1938 law governing FDA will help to protect the health and safety of consumers by globalizing the reach of FDA to reflect today’s global pharmaceutical supply chain and ensuring that all drug manufacturing facilities that supply the U.S. market are regularly inspected, regardless of whether they are based inside the U.S. or outside our borders," Bresch added.
"In particular, I am proud that the generics industry, through the landmark Generic Drug User Fee Act, has stepped up to the plate to help address an industry wide issue by providing FDA with approximately $1.5 billion over five years in order to help fund these increased inspections of drug facilities and ensure faster and more predictable review of generic drug applications."