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POSTMARKETING STUDIES MAY PRESENT COMPETITIVE DISADVANTAGE FOR DRUGS WITH LIMITED PATENT PROTECTION: DRUG FIRMS SHOULD BE CAREFUL WITH FDA COMMITMENTS

Executive Summary

Sponsors of new chemical entities that have little or no patent protection should carefully weigh FDA proposals for postmarketing studies as a condition to approval, Washington attorney William Vodra (Arnold & Porter) advised at a Dec. 9 session of the Food & Drug Law Institute annual meeting. Drug manufacturers should give "very serious consideration of any long or expensive Phase IV requirements proposed by FDA as a condition for approval," Vodra said. If the postmarketing studies are conducted over a period of five or more years and the patent has expired, he explained, the innovator will face competition from generic companies, who "will not have to spend a penny on Phase IV requirements." "The old maxim," Vodra said, "was promise FDA anything [to] get your approval." He said: "It's still good advice if you've got long patent protection, but if you've got a product that has two more years to run on the patent . . . think seriously about taking on a Phase IV that may be as expensive as all your research just completed." The ANDA/patent law has also changed the formula for determining which indication a company tries to get approved first, particularly if the new chemical entity lacks strong patent protection, Vodra asserted. The ANDA/patent law has the greatest impact on "certain marginal products" with little or no patent protection, Vodra noted, because five years of freedom from ANDA competition is granted for the initial approval of new chemical entities. NDA sponsors should try to get initial approval for the "fattest" indications, those with the greatest sales potential, he maintained. The standard rule formerly advised sponsors to "get your quickest and cheapest claim or indication approved first; get on the market; start selling your product; you can always add second and third indications down the road, and in the meantime doctors will pick up these other uses from the literature." However, that advice is no longer sound for marginally protected products, Vodra continued, because of "major delays" in FDA approval of NDA supplements, despite the agency's efforts to speed the process. For example, he pointed out, a supplement for an antihypertensive indication for oral verapamil has been pending for four years, and, in the meantime, generic versions of the oral product have already been approved for angina ("The Pink Sheet" Aug. 25, In Brief). On the other hand, Vodra noted an exception to the rule stems from the Orphan Drug law. "If you can jimmy an orphan drug claim for your product, then think about it," he said. An initial orphan indication is more quickly approved and provides seven years of monopoly protection, he pointed out. The sponsor "then can develop other uses as time goes on." The ANDA/patent law should significantly affect planning for additional indications, Vodra continued. Because the three-year exclusivity for NDA supplements effectively prohibits only generic labeling of a new use, manufacturers should try to link the new use to a new dosage form. Furthermore, because the three-year period is awarded only for NDA supplements approved on the basis of required clinical studies, Vodra advised that NDA holders file an ANDA suitability petition for their own product variations before initiating the trials. "If FDA approves it for whatever reason, you then avoid the whole process" of clinical trials; however, he said, "if FDA turns [the petition] down and says, no, clinical studies are necessary, you then have a binding decision from the FDA" that you deserve three years of exclusivity for the supplemental approval.
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