US FDA Unveils Generic Drug Approval Speed-Up Plan
The US Food and Drug Administration unveiled a proposal on the 4th October in which the approval process for generic drugs would be quickened. Additionally, said the US regulator, it would deal with the large number of applications made by the manufacturers of these products that are still pending approval.
Officials at the US FDA briefly detailed several recent changes designed to refine the approval process for low-cost versions of established drugs.
Importantly, the agency confirmed that, with immediate effect, it would start processing generic drug applications in cases where the patent protection has been lost. Traditionally, applications of this kind are given less priority than cases where the drug in question still has years to run on its patent.
Another measure outlined by the FDA was the prospect of taking on more employees to complement the 215 workers presently tasked with reviewing applications made regarding generic drugs. This, however, is dependent on the necessary finances being in place, which will be known upon US Congress' response to the FDA's budget request - a decision anticipated to have been made by the end of 2007.
In contrast to traditional drug manufacturers, firms that make generic drugs are not required to pay the US FDA user fees, which it offsets against the salaries paid to reviewers of new applications. When attempts to establish user fees for generic drug firms have occurred, they have been met with opposition by the Generic Pharmaceutical Association. Among the groups belonging to the association are Teva Pharmaceutical Industries, Barr Pharmaceuticals and Mylan Laboratories.
The group's response to the FDA's unveiled speed-up proposal was a cool one. In its eyes, the best method by which approvals for new generic drug products can be expedited is a ban on the strategies employed by branded companies when protecting their drug patients.
As per the group's President, Kathleen Jaeger: "For years, the agency has tinkered around the edges with programs and initiatives designed to increase efficiency but have proven to yield little in the way of significant results. There are serious legislative and regulatory issues that must be addressed to yield a true increase in the number of affordable generics brought to market."
Source - Pharmaceutical International's US Correspondent
Other recent US FDA News Items:
US FDA Considers Creating New Drug Class
President Bush Signs US FDA Bill Into Law
Other Recent Generic Drug News Items:
Increasing Use of Generic Drugs Slows Prescription Prices
