FDA Pediatric Rule Affects ANDA Suitability Petitions

Date: Oct 13, 1999

Companies seeking FDA’s approval to submit Abbreviated New Drug Applications (ANDAs) for certain variations on innovator drug products may now face a more difficult challenge. While these so-called ANDA "Suitability Petitions" were frequently approved in the past for certain dosage form changes, new regulations designed to require sponsors to develop data on pediatric uses of their drugs may limit FDA’s willingness to approve such petitions in the future. The agency’s "Pediatric Rule" became effective on April 1, 1999. 63 Fed. Reg. 66632 (December 2, 1998). Under these regulations,

[E]ach application for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration shall contain data that are adequate to assess the safety and effectiveness of the drug product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the drug is safe and effective.

New 21 C.F.R. § 314.55(a) (63 Fed. Reg. at 66670) (underlining added). Under certain circumstances, FDA may grant a waiver from the study pediatric requirements, although the applicant bears the burden of convincing the agency that the criteria are satisfied.

In the preamble to the final rule, FDA noted the effect that this requirement might have on Suitability Petitions. While reporting that the agency does not require bioequivalence studies to be conducted in children,

FDA notes that [Suitability Petitions] for a change in active ingredient, dosage form, or route of administration may be denied if ‘investigations must be conducted to show the safety and effectiveness of’ the change. Thus, if a petition is submitted for a change that would require a pediatric study under this rule, the petition may be denied.

63 Fed. Reg. at 66641 (FDA response to Comment 10).

FDA recently followed through on this guidance. In April 1998, Andrx Pharmaceuticals submitted a Suitability Petition (Docket No. 98P-0225) with respect to two strengths of Omeprazole Delayed-release Capsules (Prilosec®). Andrx sought FDA’s approval to submit an ANDA for Omeprazole Delayed-release Tablets (i.e., a change in dosage form permitted under the Federal Food, Drug, and Cosmetic Act). FDA granted the Suitability Petition on December 3, 1998 with a standard response letter, concluding that "[clinical] investigations are not necessary" to assure the safety and effectiveness of the proposed drug product. On September 16, 1999, however, FDA withdrew its December 3 approval, citing the Pediatric Rule as a basis for concluding that clinical investigations are, in fact, necessary for this drug product, and the fact that Andrx had not submitted an ANDA based on the Suitability Petition by April 1.

The effect is that Suitability Petitions for certain dosage form changes may no longer get the seemingly "rubber stamp" approval that had been the agency’s past practice. An applicant seeking approval of Suitability Petition may now face a much heavier burden to convince FDA that the proposed drug product does not require pediatric studies.

Prilosec® is a registered trademark of AstraZeneca.

For further information on this subject, please contact Frederick A. Stearns at 202-434-4288 or via e-mail at stearns@khlaw.com.