Negotiations for pediatric labeling changes would be limited to six months under a proposed bill to reauthorize the pediatric exclusivity provisions.

The "Best Pharmaceuticals for Children Act" (S 838), introduced May 7 by Sens. Dodd (D-Conn.) and DeWine (R-Ohio), establishes a specific timeline and process for adding pediatric information to labeling.

The bill directs that when a pediatric supplement is "approvable" and "that the only open issue for final action on the supplement is the reaching of an agreement between the sponsor of the application and [FDA] on appropriate changes to the labeling," FDA will cut off negotiations within 180 days.

At that time, the agency would "request that the sponsor of the application make any labeling change that [FDA] determines to be appropriate."

Cases in which sponsors disagree with FDA's suggested changes are to be referred "immediately" to FDA's Anti-Infective Drugs Advisory Committee/Pediatric Subcommittee. The committee would review the pediatric study reports and proposed labeling changes within 60 days.

FDA would have 30 days to review the recommendations and propose labeling changes to the sponsor. The sponsor would have an additional 30 days to agree to the change. If it does not, FDA "may deem the drug that is the subject of the application to be misbranded."

The bill would create an FDA Office of Pediatric Therapeutics to coordinate all activities affecting the pediatric population.

The bill would reauthorize pediatric exclusivity incentives until Oct. 1, 2007, putting pediatric reauthorization on the same legislative cycle as the Prescription Drug User Fee Act. The current program, created by the earlier Dodd/DeWine "Better Pharmaceuticals For Children Act," sunsets at the end of calendar year 2001; PDUFA II sunsets at the end of fiscal year 2002.

The pediatric reauthorization bill would eliminate the user fee waiver for pediatric supplements. All pediatric supplements would be reviewed as "priority supplements" and will be subject to PDUFA performance goals.

Pediatric reauthorization legislation is expected to be introduced in the House by Rep. Greenwood (R-Penn.). Commerce Committee Vice Chairman Burr (R-N.C.) hopes to reauthorize both pediatric provisions and PDUFA in 2001 (¹ [A#00630190000]).

The Dodd and DeWine bill would also provide a mechanism for the study of off-patent drugs. A federal fund would be created for off-patent research with an initial appropriation of $200 mil in FY 2002.

The bill does not offer alternative incentives suggested by FDA in its exclusivity status report to Congress, such as exclusivity awards that could be transferred to products that still have patent life (² [A#00630030021]).

Under the bill, within one year, the National Institutes of Health, in consultation with FDA and the U.S. Pharmacopoeia, would develop and prioritize a list of off-patent drugs for which additional studies are necessary in the pediatric population.

If manufacturers of off-patent drugs decline to conduct studies, a request for contract proposals would be issued to entities that have expertise in the conduct of pediatric clinical trials, including universities, hospitals, contract research organizations and pediatric pharmacology research units.

Following the completion of contracted studies, FDA would place study reports in the public domain and establish a docket number to receive comments.

The agency could request labeling changes if necessary and negotiate with manufacturers. Requested labeling changes would be published in the Federal Register, and disputes would be brought to the pediatric subcommittee.

The agency had also suggested the reauthorization provide for a second written request and additional incentives to encourage research in younger age groups. Instead, the bill instructs FDA to include neonates in initial pediatric study requests.

Dodd suggested during a May 8 hearing of the Senate Health Committee that he would consider adding additional pediatric subject protections to the bill.

Pediatric Labeling Negotiations Limited To 6 Months In Reauthorization Bill

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