New fees, new programs
While the politicians make promises, FDA has been very busy developing policies and procedures to implement important new
user fee programs for generic drugs and biosimilars and to update the fee program for brand-name drugs (PDUFA). The Generic
Drug User Fee Amendments (GDUFA) will provide almost $300 million a year—$1.5 billion over five years—and promises an end
to multi-year reviews for new generics. New application fees will support a more efficient review process by the Office of
Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER), while a one-time "backlog fee" will finance a five-year
effort to eliminate a massive review queue.
FDA also will collect about $175 million a year from facilities that produce generic drugs and active ingredients for drug
products. The goal is to support manufacturing inspections of all producers on a regular basis, and to level the playing field
for foreign and domestic firms by 2017. Timely inspections will prevent delays in application reviews. And the process of
collecting more complete electronic data on some 3,000 drug manufacturing, packaging, and distribution operations will support
FDA efforts to track producers of adulterated products and address global supply chain issues.
Implementing GDUFA will involve a significant expansion in OGD staff on all levels, and CDER director Janet Woodcock is reorganizing
her operation to provide a broader management structure to oversee this more complex generic drug regulatory program. Woodcock
plans to elevate OGD to a "super office" that can house a larger number of offices and divisions. Instead of being part of
CDER's Office of Pharmaceutical Science (OPS), OGD will be an umbrella organization, parallel to the Office of New Drugs and
Office of Compliance. New OGD director Greg Geba will head the super OGD, reporting directly to the center director.
Tracking Drug Samples
In addition, Woodcock proposes establishing a new Office of Pharmaceutical Quality, which will absorb other OPS functions
as well as some activities performed by the Office of Manufacturing and Product Quality in CDER's Office of Compliance. This
change reflects the heightened importance of assuring drug quality in the wake of widespread shortages of critical drugs and
holes in the global supply chain, many arising from manufacturing problems that precipitated plant closures and product recalls.
"Quality is the underpinning of everything we do," said Woodcock in a staff memo, noting the need for systems in this area
as "robust" as CDER programs for ensuring drug efficacy and safety. She wants the capacity to identify and respond to quality
issues before they become problems.
Commissioner Hamburg raised similar concerns at last month's FDA Science Writers Symposium as part of a discussion on the
importance of regulatory science by FDA staffers and through collaborations to streamline methods for ensuring the efficacy
and safety of medical products. To highlight important scientific discoveries coming out of FDA labs, she unveiled a new device
that can rapidly detect adulterated and counterfeit drugs coming into the US—the Counterfeit Detection Device No. 3 (CD3)—which
was developed at FDA's Forensic Chemistry Center in Cincinnati.
Hamburg also acknowledged FDA's "worrisome" budget problem, which could undermine such scientific endeavors. In this difficult
fiscal environment, she noted, policy makers often fail to view agency science programs as important, even though FDA "is
in a unique position," Hamburg noted, to identify scientific gaps needed to get products to market, and to monitor products
to protect public health.
Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at