Sec. 406. Product hopping
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In this section— the term biological product has the meaning given that term in section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); the term drug has the meaning given that term in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ); and the term product hopping means a circumstance in which— a manufacturer reformulates a drug or biological product in such a way that allows the manufacturer to submit a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) or new application for a license under section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ) with respect to such new formulation; the new formulation described in subparagraph
(A)is intended for the treatment of the same medical condition as the drug or biological product that was reformulated; and actions are taken to reduce or eliminate demand for the original drug or biological product. The Federal Trade Commission shall submit to Congress a report on the extent to which— manufacturers of drugs and biological products engage in product hopping, including an analysis of the timing of the introduction of the reformulated product relative to the market entry of a drug approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act or biological product licensed under section 351(k) of the Public Health Service Act, the types of changes made in the new product, the patents and market exclusivities awarded to reformulated products, and the various forms of product hopping manufacturers employ; manufacturers assess the profitability of a new product based whether it launches before (or how long before) generic entry occurs on the original product; the effect of product-hopping behavior on consumers, including the total estimated annual cost to consumers of physicians prescribing the substituted drug in place of a generic version of the original product; the effect of product-hopping on insurance prices and availability, including cost increases and coverage reductions attributable to the economic losses described in paragraph (3); product hopping affects manufacturer profits, revenues, unit sales, and prices; and product hopping affects the unit sales, manufacturer profits, and prices of the generic version of the original product.
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