Executive Briefing Series (formerly The Food & Drug Letter)

The FDA and generic drug companies met five times over the course of the last year to craft a generic drug user fee program that both parties could live with. The goal was to increase agency resources to deal with the high volume of submissions and speed access of new generics to patients while not discouraging the industry with overly burdensome fees. At a public meeting in February 2011, FDA Commissioner Margaret Hamburg said the FDA is “at a tipping point … Looking ahead, it is clear that FDA will not be able to make ends meet with current resourcing, and more approvals will be delayed because of a lack of inspectional resources … Uncertainty and delays are costly to consumers, costly to industry — and hurtful to the public.” Earlier this month, the FDA delivered to Capitol Hill statutory language for a Generic Drug User Fee Act. Sen. Tom Harkin (D-Iowa), who chairs the Health, Education, Labor, & Pensions Committee, has set a March goal of passing GDUFA, along with reauthorization of user fee programs for brand name drugs and biologicals. This issue of The Food & Drug Letter takes a look at what the user fee program will look like — from the proposed fees to review timeframes and what happens when fees aren’t paid—and how it will change the playing field for both industry and the FDA.

Generic drugmakers won’t have long to wait after Congress passes a user fee bill to learn the various fee levels in the Generic Drug User Fee Act (GDUFA).

The FDA hopes to take harsh measures to deal with its abbreviated new drug application backlog, saying it would refuse to receive any new ANDAs or supplements from generic drugmakers that do not pay a one-time ‘backlog’ fee under the Generic Drug User Fee Act (GDUFA) agreement.

The FDA’s proposed submission fees include a one-time fee for reference of a type 2 active pharmaceutical ingredient drug master file (DMF).

Generic drugmakers producing finished dose products or active pharmaceutical ingredients (API) outside the U.S. will pay an annual facility fee between $15,000 and $30,000 higher than that for domestic plants to cover the additional cost of overseas inspections.

Generic drug manufacturers that don’t pay the new user fees could face “significant consequences,” according to Peter Beckerman, FDA senior policy advisor in the Office of the Commissioner.

The FDA’s Office of Generic Drugs (OGD) is preparing for increased staff and upgraded reporting expected by the Generic Drug User Fee Act (GDUFA) even before the act is introduced in Congress.

Drugmakers could see an earlier passage of a user fee bill for generics and biosimilars thanks to an ambitious goal set by the chair of the Senate Health, Education, Labor, & Pensions Committee.