[That’s my own headline. The actual Reuters headline is “FDA aims to speed generic drugs to market,” which isn’t consistent with the body of the article. Things have been getting worse, not better, for generic-drug applicants and the backlog of applications is now much larger than what is shown in the chart in #msg-23007427.]
WASHINGTON, Oct 4 (Reuters) - The U.S. Food and Drug Administration on Thursday said it approved one-third more generic drugs last fiscal year and said it planned to speed review of these cheaper versions of brand-name drugs.
Officials said the push includes an expedited review process using an updated electronic format and team reviews of multiple applications for the same product.
The FDA said it approved a record 682 generic drugs in fiscal year 2007 ended last week and faces a backlog of 1,300 applications, up from about 800 about a year ago.
"These applications represent a vast scope of products -- and over half are still protected by patents. There is no way we could approve all of these applications," Gary Buehler, FDA director for generic drugs, told reporters on a conference call.
"We had no anticipation that the number of generic applications would skyrocket as it did" in the past several years, he added. [Was this really hard to foresee?]
…The Generic Pharmaceutical Association, which represents most of the industry, called the generic review effort weak. The group wants limits on the practice of brand-name drugmakers petitioning the agency to stop generic applications, which holds up approval times substantially. The group also called for more resources, not part of the FDA's plans.
"Another initiative in name only simply will not get the job done," Kathleen Jaeger, president of the group, said.
"For years, the agency has tinkered around the edges with programs and initiatives designed to increase efficiency but have proven to yield little in the way of significant results."
The agency said it might get more resources under a request now before the U.S. Congress, but its plans are based on its current funds and staff.
The agency said it received 880 generic applications in fiscal year 2007, compared with 792 applications in fiscal year 2006.
Unlike their brand name counterparts, generic drug companies do not pay user-fees to help fund review of applications. The industry opposes the fees. <<
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