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FDA Struggles to Keep Pace With Requests for Generics
Date:10/4/2007

ts, for which there are no patent problems or exclusivity protections when they are submitted for approval, will receive expedited review, officials said.

There are some 215 full-time FDA staffers working on reviews of generic drug applications. Under the GIVE program, the agency hopes to hire and train new generic drug reviewers, provided funding is approved by Congress. The agency also plans to enhance its use of computer programs for handling drug submissions, officials said.

All generic drugs undergo a scientific review for quality, safety, and effectiveness. And drug manufacturers must prove that a generic drug has the same dosage, strength, route of administration, and intended use as an approved brand-name drug, the FDA said.

Drug makers also must show that a generic drug has the same amount of active ingredient as a brand-name drug and delivers it in the same amount of time. This "bioequivalence" ensures that a generic drug has the same therapeutic benefit as a brand-name drug.

Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association, doesn't think the FDA's efforts have been enough.

"While we all share the goal of increasing efficiency in the generic approval system, another initiative in name only simply will not get the job done," Jaeger said in a prepared statement. "What consumers need is for the FDA to address the core fundamental issues that are blocking timely consumer access to affordable generics."

These issues include the citizen petition process, scientific consultations, enhanced communication, more inspection resources, accountability and structure of the Office of Generic Drug Program, she 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," Jaeger said.

To help solve these problems, the association is sugges
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