Pediatric Studies Need Not Apply To Each Product Given Exclusivity - Judge

Pediatric provisions in the FDA Modernization Act do not mandate that pediatric studies have to be "extrapolatable" from specific drug products to other products in the line containing the same active moiety, D.C. Federal Court Judge James Robertson indicated at an April 9 hearing.

Robertson replied to objections from generic industry council Daniel Jarcho that studies of one drug product do not necessarily apply to another drug product containing the same active moiety, maintaining that "the statute doesn't say they have to."

The National Pharmaceutical Alliance and the Generic Pharmaceutical Industry Association are seeking a preliminary injunction to stop further implementation of the FDA Modernization Act provisions.

The lawsuit objects to several aspects of the agency's implementation of the pediatric study provisions, including FDA's interpretation of the statute as covering all drugs in a company's product line having the same active moiety as the drug studied.

The generic groups maintain that FDA's active moiety interpretation conflicts with the statutory purpose of maximizing pediatric drug use information as it provides an incentive to conduct pediatric studies in only one product in a drug line and awards exclusivity to all products containing the same active moiety even if a product is not suitable for pediatric use.

Asked for an example, Jarcho pointed to Glaxo's OTC version of the anti-ulcer drug ranitidine (Zantac 75). FDA granted exclusivity to Glaxo's seven-product line, including the OTC for heartburn, based on pediatric studies of the prescription ulcer medication.

"What I gather the dispute is," Robertson summarized, is that, according to the generics industry, the "deal that Congress offered is, show us drug product by drug product what the benefit in children is, and we'll" give you six months of exclusivity for those products shown to have pediatric benefit. The other interpretation of the pediatric provisions is that Congress intended companies to have a stronger incentive to add pediatric information to the available body of literature, Robertson said.

Robertson expressed doubt that Jarcho's arguments proved that Congress's intent in defining drug for the purposes of marketing exclusivity was clear.

Because of the absence of unambiguous evidence of the intent of Congress, he continued, the case hinges on a Supreme Court precedent instructing the judiciary to defer to the expertise of regulatory agencies.

The Pharmaceutical Research & Manufacturers of America, arguing as intervenor on the side of FDA, declared that the statute sought to "leverage the adult population" as an attempt to provide a stronger incentive for studying drugs for use specifically in the smaller pediatric market.

PhRMA counsel Bruce Kuhlik argued that Congress would have been explicit had it intended for the term "drug" to be interpreted as a particular drug product.

Kuhlick maintained that the incentive is working, pointing to the number of proposed pediatric study requests from companies received by FDA. As of March 26, the agency had received 109 requests, and acted on 63. Of those acted upon, 49 written requests have been issued. "If anything, this program should be speeded up," rather than temporarily shut down, Kuhlick said.

When asked by Robertson if companies would stop pediatric studies if a preliminary injunction were granted, Kuhlick maintained that companies would not start new pediatric studies and would lack needed FDA guidance on ongoing and planned pediatric studies being conducted under the exclusivity incentive.

Jarcho also argued that FDA failed in its statutory requirement to prioritize drugs since the list it issued was not ranked.

The American Academy of Pediatrics has also requested to join the case as defendant-intervenor. Robertson questioned whether AAP is "an appropriate intervenor," and asked AAP lawyer Stephan Lawton to defend AAP's status of intervenor in his arguments.

Lawton cited the academy's expertise on the subject of drug use in children and the association's interest in children in contrast to the strictly pecuniary interest of the trade associations involved in the suit as reasons AAP is an appropriate intervenor.

The court accepted an amicus brief from the National Association of Pharmaceutical Manufacturers. Robertson said that he expects to rule on the injunction request shortly.