A generic drug would not have to include pediatric information in labeling in order to be approved under the pediatric exclusivity reauthorization bill passed by the House Commerce Committee.

A generic drug "shall not be considered misbranded...even when its labeling omits a pediatric use that is protected by patent or by market exclusivity," the bill says.

However, if a brand company has exclusivity rights to pediatric labeling, the bill states that FDA may require labeling for the generic version to include warnings against unsafe pediatric use and a statement that the drug is not "labeled for the protected pediatric use."

The provision was suggested by Reps. Henry Waxman (D-Calif.) and Sherrod Brown (D-Ohio) and included in Commerce Committee Chairman Billy Tauzin's (R-La.) version of the pediatric bill (HR 2887) by Reps. Anna Eshoo (D-Calif.) and James Greenwood (R-Penn.). The bill passed out of committee without amendment.

The labeling provision would eliminate attempts by brand manufacturers to claim pediatric changes to labeling entitles their products to three years of additional exclusivity under Waxman/Hatch, as Bristol-Myers Squibb is trying to do for Glucophage (metformin) and BuSpar (buspirone). Approval of the generic versions of the Bristol products is on hold while FDA considers the company's claim (¹ Also see "Bristol BuSpar Pediatric Labeling May Delay Second Round Of Generics" - Pink Sheet, 1 October, 2001.).

Eshoo called Bristol's argument "a bastardization" of the Waxman/Hatch law. "That is really a mockery of what that law is all about. Republicans and Democrats alike should rise in opposition to what that company did, and send a message out that we're not going to put up with that," she said.

Commerce/Health Subcommittee Chairman Michael Bilirakis (R- Fl.) suggested that the language of the provision could undergo further modification. "This component is highly complicated," he said, "and we will continue to work with the minority and affected stakeholders to ensure that the language addresses those concerns appropriately before the bill reaches the House floor."

He reassured colleagues that "these changes have been carefully constructed and reviewed so as not to erode the incentives under the pediatric exclusivity program."

The provision would still leave the door open to arguments that labeling changes in general are grounds for halting ANDA approvals.

Rep. Bart Stupak (D-Mich.) offered an amendment that would tie exclusivity to the completion of appropriate labeling changes on pediatric use.

"I can't understand why we allow drug manufacturers to make hundreds of millions, even billions, of dollars from agreeing to undertake a pediatric study where we don't tell anyone what the results are," Stupak said.

Stupak cited Lilly's Prozac (fluoxetine) as an example of the problem. The public benefit of Prozac pediatric studies "is zero because the manufacturer has yet to place any information on the public record regarding pediatric dosing," he said. "They can have their money, but not without full disclosure of this needed safety information for doctors, patients and their families."

Prozac's pediatric exclusivity expired in August. Lilly says it is working with FDA on incorporating pediatric information into its labeling.

The Stupak amendment was defeated because of concerns that it would create what Greenwood called "uncertainty" about when exclusivity could start, thereby weakening the incentive. However, the Republican leaders pledged to work on a compromise with Democrats before the bill reaches the House floor. "There's no question [labeling changes] should be done on a timely basis," Bilirakis said.

A provision to grant funding to study on-patent drugs whose sponsors decline FDA's request for pediatric trials is also in the bill, following negotiations with Rep. Frank Pallone (D-N.J.). A non-profit corporation, independent of the government, called the Foundation for Pediatric Research, would be established by the bill to collect funds and award grants for research. If it lacks sufficient funding for a study, NIH funds for off-patent drug testing could be used.

The bill would allow FDA to assess user fees for reviewing pediatric supplements.

Pediatric Labeling Would Not Block Generic Approval - House Exclusivity Bill

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