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 products.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.
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.