Legislation restoring FDA's authority to require drug sponsors to conduct trials in children would sunset at the same time as the pediatric exclusivity incentive program under a bill adopted by the Senate July 23.

The 2007 sunset was kept in the final version of the "¹ Pediatric Research Equity Act of 2003" (S 650) despite opposition by the American Academy of Pediatrics and the Democratic sponsors of the bill, Sens. Christopher Dodd (Conn.), Hillary Clinton (N.Y.) and Edward Kennedy (Mass.).

The provision was supported by the Pharmaceutical Research & Manufacturers of America, which argues that because the "carrot" of six months exclusivity for pediatric research has a sunset, it is only fair that the "stick" (FDA's authority to require studies) has a similar provision. The sunset was added to the bill during a Health Committee markup by Chairman Judd Gregg (² 'The Pink Sheet' March 24, 2003, In Brief).

The Senate-passed bill includes an amendment to the marked-up version advocated by the AAP. One change in the language clarifies that FDA may deem a drug misbranded "solely for" failure of the sponsor to conduct pediatric studies required under the act.

The amendment also makes the bill applicable to all NDAs and BLAs submitted "on or after April 1, 1999," the date on which FDA's pediatric rule first took effect. The regulation was challenged and eventually struck down in Washington, D.C. federal court on Oct. 17, 2002 (³ [A#00640420002], p. 4).

"Since the pediatric rule was struck down...more than 300 pediatric studies could be lost unless the legislation had a specific effective date provision," the AAP said.

The amendment additionally outlines how a provision enabling FDA to grant waivers or deferrals of the studies would apply retroactively. All waivers and deferrals already issued would be extended by "the number of days between Oct. 17, 2002 and the date of enactment" of the bill.

Sponsors not previously granted a waiver or deferral would have until a year after passage of the law to complete and submit the studies or until a date set by FDA, whichever is later, the bill says.

Both FDA Commissioner McClellan and PhRMA issued statements supporting the legislation and urging swift passage in the House. A companion bill (HR 2857) was introduced July 25. AAP is targeting September for a vote.

FDA Pediatric Study Bill Clears Senate, Will Sunset With Exclusivity Grants

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