At a time when healthcare costs are escalating and millions of Americans are uninsured, generic drugs have emerged as the
answer to the nation's healthcare woes. Low-cost prescription drugs can ease patient access to medicines, reduce insurance
outlays, curb Medicare and Medicaid spending, and improve the overall quality of care.
The clamor for generic drugs puts added pressure on the US Food and Drug Administration to bring new generic drugs to market
as fast as they can be developed, produced, and evaluated. This task will remain a challenge as more blockbuster brand-name
products lose patent protection, thus generating more applications and other documents for the agency to consider.
FDA is doing all it can to streamline its generic-drug review process. The agency's lack of resources makes the task difficult,
however, as do established policies that often delay when a new generic product can come to market. The debate continues about
whether generic versions of biotechnology therapies can be safe and effective and less costly than their more complex reference
FDA officials would like to collect user fees from generic drug makers to expand the agency's resources devoted to this area.
Industry, however, wants to link fees to clear improvements in the review process and reduced barriers to market. Future legislation
to facilitate approval of "biosimilars" may provide a vehicle for a generic-drug user fee program as well as other changes
in current policies governing generic-drug development and approval.
A main challenge for generics makers is to move applications as fast as possible through a complex review process for abbreviated
new drug applications (ANDAs). FDA's Office of Generic Drugs (GPhA) has launched several new initiatives during the last few years to accelerate reviews and reduce application backlogs. The
initiatives have facilitated the approval of some important new generic therapies in recent months, including generic versions
of extended release pro-ducts, inhalation solutions, and a leading topical product. FDA also has provided expedited reviews
for important generic versions of AIDS treatments, which qualifies the products for purchase by the President's Emergency Plan for AIDS Relief, which provides drugs to Africa and developing nations.
Yet the steady rise in new ANDAs coming in the door makes it hard to raise FDA's productivity. OGD received 877 ANDAs in fiscal year 2007 (ended Sept. 30, 2007), a new high in submissions. Even though the office set another
record when it approved more than 600 ANDAs, another 200 or so applications were added to an unending backlog. More than 1300
ANDAs currently await approval, a process that takes 16 to 17 months. At the current rate of submissions, the agency finds
it difficult "to keep up with everything," said Helen Winkle, director of the Office of Pharmaceutical Science (OPS) in the
Center for Drug Evaluation and Research (CDER), at an October conference sponsored by the Generic Pharmaceutical Association
In addition to ANDAs, each newly approved generic drug generates multiple chemistry, manufacturing, and controls (CMC) supplements.
CDER receives about 4000 CMC supplements each year for brand and generic drugs and biotechnology therapies. The volume has
inspired an initiative to reduce the number of supplements that must be submitted in advance to the agency. FDA hopes to issue
guidance in early 2008 that identifies a lengthy list of low-risk postmarketing changes that may be filed in annual reports
instead of as supplements. Winkle anticipates that this initiative will reduce the supplements that FDA must review by 60%.
OGD also must deal with a massive amount of regulatory correspondence—more than 1300 documents this year, reported OGD Director Gary Buehler at the GPhA meeting. About three-fourths of the letters seek information on bioequivalence data requirements. OGD's Division of Bioequivalence takes 16 months on average to answer the letters individually.
Plus, a growing number of citizen petitions raises both legal and scientific issues. FDA receives 20 to 25 petitions each
year. Most require 8 to 10 months to review, although some take years, Winkle noted. Responding to petitions is a highly variable
process that may involve CDER's Office of New Drugs, FDA lawyers, regulatory officials, and OGD. As a result, more than 60 petitions are pending.