FDA chief says unique generics get priority
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The U.S. Food and Drug Administration is taking steps to eliminate a backlog of more than 800 pending generic drug applications by focusing on those offering the first cheaper alternative therapy, the agency’s acting chief told Congress on Tuesday.
Acting FDA Commissioner Dr. Andrew von Eschenbach defended efforts to bring cheaper drugs on the market by telling lawmakers the agency aimed to ensure “that there’s at least one generic available” for most conditions, giving preference to the first one submitted.
Similar or identical generics are less of a priority, he told the Senate Appropriations Subcommittee on Agriculture, Rural Development and Related Agencies.
“We’re looking at this in a hierarchical fashion,” von Eschenbach said at a hearing on the agency’s budget.
Sen. Herb Kohl, a Wisconsin Democrat, called on the agency chief to act more quickly to sort through waiting generics that he said could save consumers up to $10 billion a year.
Kohl questioned why the agency’s budget request did not seem to make any “effort to address that backlog,” noting the FDA budget calls for $400 million to review 88 new brand name drugs and $65 million to review 400 generics.
Von Eschenbach said the agency is approving an average of more than one generic drug each business day and was “equally committed” to both new and generic drugs.
Still, at that rate, the FDA would finish in about 3.5 years, panel chairman Utah Republican Sen. Robert Bennett said after making a quick calculation.
Supporters of generic drugs contend they work just as well as brand-name versions but cost less, and U.S. health officials often tout them as alternatives to drugs bought on the Internet or from other countries such as Canada.
The Generic Pharmaceutical Association has said FDA officials have raised the possibility of new fees for generic drug applications.
The industry group said it would only consider paying fees if the Bush administration supported legislative fixes to speed up generic reviews.
Makers of brand name drugs and medical devices currently pay fees to the agency to have their products reviewed.
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