FDA USER FEES WOULD BE DISPROPORTIONALLY HIGHER FOR ANDAs THAN NDAs

FDA USER FEES WOULD BE DISPROPORTIONALLY HIGHER FOR ANDAs THAN NDAs, the Natl. Assn. of Pharmaceutical Manufacturers (NAPM) maintained in Oct. 25 comments in opposition to FDA's proposal to collect fees for drug reviews. "The unreasonableness of the FDA proposal is clearly reflected by the disproportionate manner in which the user fee structure operates against the filing of ANDAs. This is because it makes no attempt whatsoever to compare the plannel user fees to the costs of filing each application type." For example, NAPM declared, the "published information indicates that the approximate cost of developing a full new drug application for a new chemical entity, including the investment in research required to compile such an application, is now approximately $94 mil. The proportionate cost of a user fee of $126,200 for such an application is equal to only .13% of the total cost of obtaining new drug approval." NAPM continued that "in marked contrast, using the higher of FDA's estimated cost of obtaining an ANDA, $100,000, a $9,900 user fee amounts to almost 10% of the total cost of an application. If FDA's lower figure of $25,000 is used, the user fee would equal 40% of the application cost." NAPM argued that the "enormous disparity" is "discriminatory, and unlawful for that reason." The assn. argued that the imposition of user fees is also unlawful under the Drug Price Competition and Patent Term Restoration Act of 1984. "There can be no question that FDA's proposed user fees are inconsistent with the purposes of this new legislation. There is no dispute that the ]law[ was intended to foster the entrance into the marketplace of generic drugs -- to provide high quality but low cost alternatives to brandname products," NAPM said. "Even FDA admits that the effects of the user fee proposal will be to discourage, to some extent, the entrance into the market of competitive generic drugs," NAPM observed. The assn. declared it "cannot understand how this user fee proposal can be reconciled under any circumstances with this amendment to the FD&C Act."