FDA Proposed Regulations For Generic Drugs
President Bush announced new Food and Drug Administration ("FDA") proposed regulations on October 21st. The proposed regulations change existing FDA regulations and are designed to make it more difficult for pharmaceutical companies to use patents to block generic prescription drugs from coming onto the market. Currently, pharmaceutical companies may file a 30 month stay whenever a generic drug company challenges a drug patent. The Federal Trade Commission ("FTC") released a study in July reporting that pharmaceutical companies often abuse this protection by filing multiple stays, resulting in delays of years before a generic drug may actually challenge the patent and reach the market. The new regulations would only allow a one-time stay and would forbid brand-name companies from getting new patents for certain reasons the FTC deemed frivolous and a forestallment of competition , such as different packaging for existing medicine. Much controversy has developed over the new FDA regulations.
Critics claim the FDA does not have the authority to make these new rules through alteration of regulations and that Congress must enact legislation to accomplish such changes. Congress has been debating several generic drug bills but has been unable to agree on a balance between curbing the cost of medication with preserving economic rewards for companies that invest in drug research and development. The proposed regulations will likely become tied up in litigation initiated by the drug industry or trumped by a new generic drug law before they become final.
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