FDA And Industry Discuss US Savings From Generics

At a late September meeting, representatives of the US generic pharmaceutical industry met with US Food and Drug Administration officials to seek ways "to cooperatively reverse current trends in generic drug approvals that are delaying the introduction of more affordable medicines," according to a press release from the Generic Pharmaceutical Industry Association. Timely approval of generic medicines, it claims, could save American consumers and the Medicaid program millions of health care dollars.

Citing approval times that exceed the statutory 180-day approval period, industry executives offered an array of proposals that could assist the agency in streamlining the review process. The industry also called on the FDA to "appropriately allocate resources and staff to review generic pharmaceutical applications."

Industry Suggestions For FDA Actions Among recommendations offered by the generics industry, which its representatives said would help the agency meet its statutory obligations, were: