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FDA discusses pediatric drug safety with its advisory subcommittee under BPCA

ROCKVILLE, MD., June 12, 2003 - The Food and Drug Administration (FDA) has discussed potential post-marketing drug safety issues for specific drugs that have received pediatric exclusivity under the Best Pharmaceuticals for Children Act (BPCA).

Signed into law on January 4, 2002, the BPCA specifically requires that the Office of Pediatric Therapeutics review all adverse events reported for drugs that receive pediatric exclusivity, for one year, starting on the date that the pediatric exclusivity is granted. This review is in addition to the routine daily post-marketing safety surveillance activities FDA performs for all marketed drugs through its MedWatch system.

FDA is implementing this special BPCA requirement by discussing these reviews in public with its Pediatric Advisory Subcommittee. Generally such discussions will be part of each Pediatric Advisory Subcommittee meeting.

The latest report involves four drugs that received exclusivity under the BPCA -- sertraline, oxybutynin, atorvastatin and simvastatin -- following submission of the requested clinical studies conducted to evaluate safety, effectiveness, and appropriate doses for use in children.

FDA presented 2 full reports (sertraline and oxybutynin) and 2 preliminary reports (atorvastatin and simvastatin) during a meeting of the Pediatric Advisory Subcommittee. These reports do not provide any safety signals that indicate that the Agency needs to do anything except continue to actively assess the evolving benefit -- risk profile of these products. As with all drugs when they are more widely used in the community, continued reporting of suspected safety concerns is critical so that new safety information can be evaluated and disseminated to patients, parents, and practitioners. In this way, better-informed decisions can be made about the appropriate use of specific drugs.

The BPCA renewed the exclusivity provision (extended protection from market competition) for pharmaceutical companies that conduct pediatric studies at FDA's request. This economic incentive only applies to certain drugs with existing patents or marketing exclusivity. For these drugs, this incentive has resulted in a significant increase in the number of pediatric studies performed and in important information to guide safer and more effective use of medicines in children. In addition, the BPCA mandated that FDA maintain special oversight of the safety of these products during that period when they are most likely to be initially promoted in the pediatric market.

Source: FDA

Posted: June 2003