According to Russell Wesdyk, scientific coordinator in the FDA's Office of Pharmaceutical Science, generic drug manufacturers would face fewer factory inspections and save as much as a year developing products in exchange for paying fees for the first time under a Food and Drug Administration proposal.
Terrifi. The more expeditiously generic drugs can move through the FDA process the better … but not at the expense of safety.
Wesdyk shared that the FDA may waive "preapproval inspections" done after companies submit generic-drug applications. Instead, it would rely on periodic inspections that focus on firms' broader manufacturing practices.
Really? Fewer inspections? Isn’t that going against the prevailing philosophy that FDA needs to undertake more and more rigorous inspections and particularly overseas (where many generic products are manufactured)?
Speed is important. Safety is more important. To achieve both requires the agency to have more inspectors – and that means more money for the FDA.
Safe generics brought to market more swiftly? Show me the money.
