Magazine article Drug Topics

Generic Firms Want Quicker FDA Action-And May Pay for It

Magazine article Drug Topics

Generic Firms Want Quicker FDA Action-And May Pay for It

Article excerpt

If the FDA approved generic drug applications within 180 days, as required by law, consumers would save more than $11 billion a year, the National Pharmaceutical Alliance has told Congress. The generics organization said only 12% of the ANDAs gain agency clearance within a year, and some can take up to three years to gain the right to challenge branded products. "According to FDA's estimates, 90% of ANDAs could be reviewed within the required six months if OGD [Office of Generic Drugs] had an additional $13 million annually," Tom Long, NPA's legislative counsel, testified. In a related development, Rep. Carrie Meek (D, Fla.) has introduced legislation that would encourage health plans that cover some nine million federal employees and their dependents to use generic drugs, unless the brand is specifically requested by the physician or patient.

PhRMA also is concerned about regulatory delays involving its members' products. The brand-name association charged that the Clinton Administration's proposed 8% cut in the FDA budget could add 2. …

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