Stakeholders Urge Faster Generic Approval, Save Healthcare Dollars

Earlier this week, the FDA heard from various stakeholders and experts from the healthcare industry on how delays in the generic approval process impact healthcare costs. The meeting saw participation by members of the Generics Pharmaceutical Association, Specialty Pharma Association, Bulk Pharmaceutical Task Force, and Kaiser Permanente's Medical Group.

Participants urged the FDA to reduce the generic drug review period (currently at about 50 months), which they say could have saved the healthcare system over $3 billion over a year and a half. These delays reduce access for patients who then have to turn to more expensive brand-name drugs.

Generic Drug User Fee Amendments (GDUFA) fee schedule; smaller companies or biotechs that file for an abbreviated new drug application have to pay the same GDUFA fees as big pharma, which

Perry Cole, president and executive director of Specialty Pharma Association, thinks “Is financially unfair to smaller companies.”

Another point raised during the meeting was the similar

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