The U.S. Food and Drug Administration is taking steps to eliminate a backlog of more than 800 pending generic drug applications [#msg-9566322] 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 (news, bio, voting record) 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 [#msg-9763028]. 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 <<
FDA to Offer Priority Review for Selected Generics
[This is a pretty big win for the generic manufacturers who had pushed for expedited reviews but had balked at paying user fees to the FDA. Please see #msg-9566322 for a graphic depiction of the magnitude of the backlog problem.]
>> WASHINGTON, Oct 18 (Reuters) - Bids to sell some generic drugs now will be prioritized to receive faster, six-month reviews from U.S. regulators, a top Food and Drug Administration official said on Wednesday.
Applications may undergo the expedited review if they are the first for a generic version of a drug no longer protected by a patent or market exclusivity, or if the medicine would address a public health emergency or nationwide shortage, said Dr. Steven Galson, director for FDA's Center for Drug Evaluation and Research.
The agency has a backlog of more than 800 generic drugs awaiting an approval decision under the current process that evaluates all applications in the order that it receives them. In 2005, the median time for an approval was more than 16 months, according to the FDA.
Under the new procedures, generic drug applications with priority status will expedited immediately, Galson said at a conference sponsored by the Generic Pharmaceutical Association.
"We should start seeing that right away, we think it's realistic," he said about the new six-month timeframe.
Top generic drugmakers include Teva Pharmaceutical Industries Ltd <TEVA>, Barr Pharmaceuticals Inc. <BRL>, Mylan Laboratories Inc. <MYL>, Watson Pharmaceuticals Inc <WPI> and Novartis AG's <NVS> Sandoz unit. <<
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