Going for generics
Another provision in an FDA reform bill could authorize the collection of user fees for generic drugs. The issue has been
discussed for years, but opposed by generic firms because even speedier reviews of abbreviated NDAs (ANDAs) won't help manufacturers
if patent disputes delay marketing of new products for months, or even years. However, FDA's Office of Generic Drugs (OGD)
is so overwhelmed by ANDAs (now over 800 a year) that approvals take months, and the backlog has grown to more than 2000 pending
submissions. Agency officials are therefore pushing hard for industry to agree on a GDUFA, or generic drug user fee, program.
FDA held a public meeting in September 2010 to hear from generic-drug firms, along with consumer groups and pharmacists, on
the shape and scope of such a program. FDA Commissioner Margaret Hamburg opened the session with a plea that "something must
change" to prevent a crisis situation where FDA is unable to approve a new generic drug in time to reach consumers when innovator
exclusivities expire. CDER Director Woodcock noted that generic drugs are the only FDA drug-review program not supplemented
by user fees and that it's time to "get this show on the road."
The Generic Pharmaceutical Association (GPhA) and a coalition of major manufacturers (Teva, Apotex, Hospira, and Perrigo)
agreed on the need to pay application fees to support a faster and more reliable review process. Approval goals and metrics
would be clearly spelled out, and manufacturers would be able to pay an added fee to move a product off the review queue.
Heather Bresch of Mylan, however, proposed a system with separate annual fees for approved products, for manufacturing establishments
and for inspections—but no application-review fees due to the uncertainties of when a newly approved generic drug will come
FDA wants a common GDUFA proposal from industry. Woodcock and her colleagues emphasize the need to tap fee revenues to support
timely inspections of bioequivalence testing labs and of manufacturing sites, particularly foreign producers of active pharmaceutical
ingredients. Such enhanced oversight not only could accelerate patient access to low-cost drugs, but also bolster public confidence
in the quality and safety of generic drugs.
Biosimilars take shape
Another important FDA initiative is to establish standards and policies governing the development and approval of "similar"
versions of biotech therapies. Patient and consumer groups and health plans and payers are pressing for a clear biosimilar
development pathway to facilitate access to less costly therapies, a goal that will be increasingly important as more biologics
come on the market.
FDA held a two-day public meeting in November 2010 to launch the process for establishing a framework for approving biosimilars,
as stipulated by the Affordable Care Act (ACA) enacted in March 2010 (see the December 2010 Washington Report column, "Pharma
Faces New Political Landscape"). A long list of brand and generic-drug manufacturers testified on the scope and size of tests
and data needed to document the safety and efficacy of such products, and FDA will be digesting these and other comments in
the coming months. FDA officials appeared interested in identifying a middle ground between ensuring product safety and efficacy,
and making affordable new treatments available to patients.
Commissioner Hamburg indicated at a later meeting that a complete approval pathway for biosimilars may be elusive because
the science and products will evolve continuously. For this and other reasons, some generic-drug makers suggest that they
may skip the biosimilar process altogether and seek approval of follow-ons as licensed innovator products. That approach would
benefit from some public knowledge about an innovator product, but avoid exclusivity battles and other legal issues that might
delay market approval for the follow-on product.