FDA reveals further steps to encourage generic competition
The US Food and Drug Administration (FDA) revealed additional steps aimed at encouraging generic competition today.
In June this year, the FDA announced its plan to target barriers to competition by “facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines” via its drug competition action plan.
As part of the plan, the FDA implemented a policy aimed at expediting the review of generic drug applications. The administration will expedite review until there are three approved generics for a given drug.
There are three main components in the FDA’s implementation plan.
First, to reduce “gaming” by branded companies that can delay generic drug entry.
Second, to resolve scientific and regulatory obstacles that can make it difficult to win approval of generic versions of certain complex drugs.
Third, to improve the efficiency and predictability of the FDA’s generic review process, thereby reducing the time it takes to get a generic drug approved.
In October, the FDA issued two new sets of guidance aimed at ensuring the FDA provides “as much scientific and regulatory clarity as possible with respect to complex generic drugs”.
Today, January 3, the FDA issued guidelines aimed at achieving the third goal—improving the efficiency and predictability of the FDA’s generic review process.
Two documents were released which, together, are expected to streamline and improve aspects of the submission and review of generic drug applications (known as Abbreviated New Drug Applications).
The first is a draft guidance for industry: “Good ANDA Submission Practices”.
It highlights the “common” and recurring deficiencies that the FDA sees in applications that may lead to a delay in their approval.
One of the reasons for delay is that many applications need to undergo multiple cycles of review.
While often this is because the application lacks sufficient scientific evidence to support approval, “there are also many times when the FDA must ask applicants for additional information in order to determine that the requirements for approval have been met, even if an application meets the threshold requirements for filing”, said Scott Gottlieb, the FDA’s managing director.
The FDA has also published a companion to the guidance, in the form of a Manual of Policies and Procedures. Called “Good ANDA Assessment Practices”, it outlines ANDA assessment practices for FDA staff, and formalises a more streamlined generic review process.
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories like this sent straight to your inbox.
