The Food and Drug Administration, beset by a lack of funding and staffing, is failing to keep up with the growing volume of generic drug applications and meet its obligation to approve the lower-cost prescription medicines in a timely fashion.
Although the FDA gave the go- ahead to more than 500 generic drugs last year, the agency's backlog of pending applications grew to 1,291 last month, from 780 at the end of 2005. The median approval time for new generic applications has been stalled at more than 16 months for several years, despite a statutory requirement that generic drugs be reviewed within 180 days.
Generics -- which now account for more than 60 percent of all prescriptions written in the United States -- are copies of expensive brand-name medicines, often selling at prices 20 percent to 80 percent lower than the originals. According to the National Association of Chain Drug Stores, the average retail price of a brand-name drug in 2006 was $111.02, while the average price of a generic was $32.23.
"The impact of the (FDA) delays is higher costs for consumers," said William Vaughan, a senior health policy expert for Consumers Union.
Gary Buehler, director of the FDA's Office of Generic Drugs, said his staff is "working as efficiently as it can" with the resources available to approve new generics.
"Unfortunately, we are not processing as many applications as we are getting, and that is the reason we have a backlog," he said in an interview last week.
Buehler said his office will end up receiving between 800 and 900 generic drug applications this year, with little chance of getting out from under the heavy caseload.
Ira Loss, a senior pharmaceuti cal analyst for Washington Analysis, an investment research firm, said the Bush administration and Congress have shortchanged the FDA and consumers by not provid ing adequate revenue for the agency to do its job.
"The simple answer is the FDA is underfunded, and part of underfunding is in the generic drug area, where application numbers are increasing," Loss said. "This has the effect of not reducing the drug prices as quickly as otherwise might be the case."
When a brand-name drug patent expires, generic pharmaceutical companies seek FDA approval to market their version of the innova tor's medicine. The generic firms must show their medicines are the same as the brand-name drug in chemical composition, dosage, safety, strength, how it is taken, quality, performance and intended use
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