FDA gives generic drugs 'super' status

With generic drugmakers now slated to kick in a significant piece of the FDA's outside funding, the agency appears ready to give them the position they have earned.

According to a letter from Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), the Office of Generic Drugs (OGD) is slated to become a "super Office," and so will oversee other offices. It continues to be run by Dr. Greg Geba, who was recently named to that position, only now he reports directly to Woodcock. He will lead the office's "expanding generic program with the goal of enhancing our ability to give consumers timely access to high-quality, safe, and effective generic drugs," she said.

In the letter, which is published by PharmaManufacturing, Woodcock says that with the passage of the Generic Drug User Fee Amendments of 2012 (GDUFA), and given that nearly 80% of all prescriptions in the U.S. are now of generic drugs, it makes sense to give generic drugs a superior position in FDA.

A recent study from health information firm IMS found that in 2011, U.S. payers saved $1 billion every other day, a total of $193 billion from generics.

In June, Congress passed the FDA user fee reauthorization bill. It kicks off a 5-year stretch in which the FDA is slated to have more money and new authorities in hopes that it will approve drugs faster and theoretically cut costs for consumers and taxpayers through faster approval of generics. The law will provide more than $6 billion in user fees over the 5 years and, for the first time, generic makers will pay a significant piece of those fees. The generics industry is expected in 2013 to kick in $299 million.

That program, however, is contingent upon Congress providing enough funding to the FDA to "trigger" the payments from industry and there is some concern that there might be a problem there. The chance for automatic budget cuts that were negotiated as part of a budget impasse could potentially trim $200 million next year from the FDA budget. Bloomberg reports it is not clear whether that is enough to keep the FDA from starting to collect fees, but an FDA spokeswoman did say the impasse threatens the user fee programs.

- get the PharmaManufacturing piece
- here's more from Bloomberg