The rules governing pediatric exclusivity awards may be revisited as a result of the investigation into the handling of pediatric antidepressant safety data.

"In this particular issue of antidepressants, I have learned that we need to go back and look at that pediatric exclusivity bill," Rep. Henry Waxman (D-Calif.) said during a Sept. 9 House Energy & Commerce/Oversight Subcommittee hearing on disclosure of pediatric clinical trial results.

"I think we need to change the pediatric exclusivity law," Waxman declared. "We need to require broad disclosure of the results of clinical trials."

The 2002 Best Pharmaceuticals for Children Act directs FDA to publish a summary of its review of submitted pediatric data within 180 days.

There is no requirement for the studies to be included in product labeling, nor is FDA directed to publish any studies conducted outside the scope of a specific request issued under the pediatric law.

Most of the pediatric studies of antidepressants currently under discussion were initiated under the pediatric provisions of the 1997 FDA Modernization Act. Results of pediatric studies initiated under FDAMA are only available if a pediatric supplemental indication is approved.

Following increased attention on the antidepressant data, FDA received permission from drug sponsors to post review or study summaries for all of the antidepressants on the agency's website.

During the Sept. 9 hearing, Rep. Diana DeGette (D-Colo.) told FDA Acting Deputy Commissioner for Operations Janet Woodcock, MD, that the agency should have been more proactive in making the antidepressant data available.

Waxman and Rep. Edward Markey (D-Mass.) plan to introduce legislation establishing a mandatory registry for clinical trial data.

The American Medical Association is also calling for legislation, and the association outlined a proposal to require registration of trials as a condition of IRB approval.

The hearing also provided an opportunity for the Pharmaceutical Research & Manufacturers of America and antidepressant sponsors to highlight steps they are taking to make data more available.

PhRMA announced plans for a trial results registry Sept. 7 (¹ Also see "PhRMA Clinical Trial Registry Will Be Launched Oct. 1" - Pink Sheet, 7 September, 2004.).

- Elizabeth Walker

Pediatric Exclusivity Rules May Be Revisited

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