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Executive Summary

Firms seeking to cut into an innovator's exclusivity period for an off-patent drug under the ANDA/patent law provisions may be required to do more studies for approval than the innovator firm, NAPM General Counsel Milton Bass (Bass & Ullman) cautioned at the assn.'s annual meeting at Dorado Beach, Puerto Rico on Jan. 26. Referring to Sec. 103 of the new law, which defines a "paper NDA" without identifying it as such, Bass maintained that while Hatch/Waxman allows "paper" in the original NDA, subsequent NDAs can not have any literature references and still qualify for exculsivity. Bass noted that companies generally attach literature references to supplemental NDAs "as normal course." However, he asserted, "the way the Waxman bill is written, if a second company wants to get an NDA it will have to do more studies than the innovator did." Bass asserted that companies seeking to break into an innovator's exclusivity period for an off-patent drug would "have to do every study over again, not only those that the innovator did, but even [duplicative clinical studies covering] the literature that the innovator referred to." FDA Office of Drug Standards Deputy Director James Morrison, PhD, acknowledged the NAPM lawyer's reading of the statute. Morrison noted that the law could lead to a situation where an innovator's exclusivity is based on "paper," but subsequent filings, if they include any "paper," are held up for three years. Under a literal reading of the law, Morrison pointed out, an innovator firm "may have done [its] initial approval on the basis of nothing but paper, [while] the generic firm, since it would not have had a right of reference to those papers . . . would have to do clinicals for all of the data that the innovator used paper for in order to get around exclusivity." Morrison noted that FDA is now looking at clarifying that section of the new law in the technical amendment package the agency is preparing for Rep. Waxman (D-Calif.) "Our objective," Morrison said, "is to try to get some technical amendment clarification" of Sec. 103. "Certainly one approach will be so that the generic [company] would not have to do more studies than the innovator," the FDAer suggested." If the innovator does mostly paper, than the generic people can get in with mostly paper." Morrison predicted that FDA's technical amendments to the ANDA/patent law will be forwarded to Congress "very, very shortly." Acknowledging that FDA's "batting average in getting things amended or changed in [Waxman's bill] has not been of major league caliber," Morrison added that the agency would take the reg writing approach if the clarifying amendments do not clear Congress. Waxman's staff has said it considers a "paper NDA" to be comprised exclusively of literature references and to contain no original study data. Under this reading of the statute, an NDA with any original data would be considered a full NDA. Bass suggested that FDA could require those firms seeking to break into an innovator's exclusivity period to do "that study, or studies, which were defined . . . as 'new and essential'" for which the innovator received the additional exclusivity. In addition, Bass recommended that FDA take a position in future regs on the definition of a full NDA and how much "paper" would be allowed under the new law. Asked about the agency's position on voluntary listing of inactive ingredients, Morrison commented that "listing is going to be a reality and . . . the associations that jump into the breach and offer voluntary listing are wise because it's a way of accomplishing it on the ground rules" of the industry. "I think it makes sense where there is a public health issue for the generics to jump on the bandwagon and fully support those kinds of activities and give the innovators one less thing to cry about the differences between their products and the generics," Morrison noted regarding voluntary listing guidelines. "I think it also puts you in a much better position for marketing and showing your concern for the public health," he added. While voicing his support for voluntary guidelines, panelist Joseph Barrows, Barrows Research Group, expressed his concern that listing of inactive ingredients for the public could be used by the brandname firms to the disadvantage of the generics. "If the Rx drug advertising goes forward the way it has been in the past," Barrows said, "I can see the giants showing the various different formulations of the various firms and stating these drugs cannot be considered interchangeable." In response, Morrison cautioned the NAPM members that "the potential advertising by the brandname firms and product liability might be greater if you choose not to list the inactive ingredients even though [the brandname firms] could compare their ingredients with your ingredients." He noted that the brandname firms might be able to make more use out of a refusal by generic mfrs. to list their inactive ingredients in promoting branded products.

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