The US Food and Drug Administration (FDA) is planning to elevate its Office of Generic Drugs (OGD) to a "super Office," which would house subordinate offices within its organisational structure and report directly to Dr Janet Woodcock, director of the FDA Center for Drug Evaluation and Research (CDER).
The proposal follows on from the passage of the Generic Drug User Fee Amendments of 2012 (GDUFA), which will require the industry to pay user fees, for the first time, for agency review of generic drugs, and a heightened public focus on generics.
"Generic drugs, which now make up nearly 80% of prescriptions filled in the United States, have come to represent affordable access to treatment for many patients," Dr Woodcock writes, in a letter published by PharmaManufacturing.Under the proposed restructuring, OGD director Greg Geba would continue to lead the expanding generic programme, "with the goal of enhancing our ability to give consumers timely access to high-quality, safe and effective generic drugs," Dr Woodcock writes. Mary Beth Clarke, acting director of the Office of Executive Programs, will continue to be the CDER lead on GDUFA implementation.
Dr Woodcock also discusses other plans for structural changes "to sharpen our focus and bolster our resources around pharmaceutical quality," emphasising that "quality is the underpinning of everything we do, and it is imperative that we have a drug quality programme as robust as those programmes we presently have for drug efficacy and drug safety.""Further, we must be strategic and have systems in place to identify and respond to quality issues before they become problems. This is especially critical due to the global nature of drug manufacturing and the sourcing of raw materials outside of the United States,” she writes.
Therefore, the FDA is exploring the creation of a new Office of Pharmaceutical Quality (OPQ), which would be charged with overseeing quality through the life cycle of a drug. The new Office could take on some of the functions currently within the Office of Pharmaceutical Science (OPS) and other quality functions, says Dr Woodcock. She is also proposing to realign some functions from the Office of Manufacturing and product Quality (OMPQ) in the Office of Compliance into the new OPQ,"All of these changes would be part of our ongoing efforts to ensure that CDER's organisational structure supports our mission to ensure safe, effective and high-quality drugs to the public," she writes.
In July, President Barack Obama signed into law the FDA Safety and Innovation Act (FDASIA), which sets out the user fees which industry will pay to the agency over the next five years, starting on October 1. Within this legislative package, GDUFA requires the generics industry to pay $299 million annually to the FDA over the five years, and these new fees are expected to reduce the average review time for most generic drug applications by nearly two years, from more than 30 months at present to 10 months by the end of the programme's fifth year.
The fees will also provide increased funding for generic manufacturing facility inspections, which are required before new generics can be approved, industry group the Generic Pharmaceutical Association (GPhA) points out.
Generics account for 80% of prescriptions filled in the US but for only 27% of total drug spending, adds GPhA, which recently released new research showing that savings to consumers and the US health care system from the use of generic prescription drugs has now reached $1 billion every other day.
Savings from generics rose 22% in 2011 compared to 2010, to reach $193 billion for the year, and totalled more than $1 trillion during 2002-2011, says the study, which was conducted for GPhA by the IMS Institute for Healthcare Informatics.