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Executive Summary

Prescription drugs with "FDA approved" trials conducted on pediatric populations would receive six months' exclusivity under legislation introduced Oct. 5 by Sen. Kassebaum (R-Kansas). The bill (S 3337) adds six months of additional protection from generic competition for products in which pediatric studies were conducted before approval or after marketing and at the request of FDA. According to a summary of the legislation, the exclusivity period would start "on the earliest date on which an approval of the application for a generic copy of the drug could otherwise be made effective." The bill provides "six months' exclusivity for products for which FDA-approved pediatric studies are conducted," Kassebaum said in her statement on the Senate floor. "A drug qualifying for this exclusivity would not be subject to new generic competition for six months after the expiration of its patent or other exclusivity under current law." Eligible products are those "not ordinarily studied in children," Kassebaum explained. Therefore, the bill excludes antibiotic, anti-asthmatic and anti-allergy medication and drugs for "conditions that occur only in children." Noting that pediatric testing currently "is performed only haphazardly," Kassebaum said her bill "creates incentives for drug manufacturers to test the impact of drug products in pediatric populations." She noted that the proposed incentive is modeled on the exclusivity provisions of the 1983 Orphan Drug Act and the 1984 ANDA/patent law. Because "pharmaceutical products are seldom studied in younger populations," Kassebaum said, "physicians who wish to use these drugs for pediatric patients are forced to estimate pediatric dosages from the dosages found to be safe and effective in adults." She pointed out that "such estimates are sometimes uncertain" because children "frequently metabolize drugs differently than do adults." FDA has promoted geriatric testing and labeling without the use of legislative exclusivity incentives. The agency also has proposed to base pediatric indications on study data from adults (see preceding story). The Kansas senator noted that she has worked with the Pharmaceutical Manufacturers Association, the American Academy of Pediatrics and FDA in drafting the bill. She explained that the bill was introduced in the waning hours of the 102nd Congress to elicit comments over the next few months so that they can be accommodated in a new bill "when the new Congress convenes" and the proposal can be considered "expeditiously."

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