Animal Drug Amendments and Patent Term Restoration Act of 1988

Summary

Animal Drug Amendments and Patent Term Restoration Act of 1988 - Title I: New Animal Drug Amendments - Amends the Federal Food, Drug, and Cosmetic Act to authorize abbreviated applications for the approval of a new animal drug. Requires such application to show that permitted uses, ingredients, dosages, labeling, and other factors are the same as or bioequivalent to a new animal drug already approved. Requires such application to contain a certification relating to patents covering the approved drug. Requires an applicant who makes such a certification to state in the application that a specified notice has been given to each owner of the patent (or owner-representative) and the holder (or holder-representative) of the approved application for the drug or drug use claimed by the patent. Requires the permission of the Secretary of Health and Human Services before an abbreviated application may be filed for a new drug whose route of administration, dosage form, or strength differs from that of an approved new animal drug. Requires the Secretary to publish and update a list of the official and proprietary name of each new animal drug which has been approved and continues to be approved for safety and effectiveness, including patent information as it comes in. Directs the Secretary to approve an application for a drug unless the Secretary makes specified findings, such as faulty manufacture or insufficient information. Sets forth a formula for determining when an approved application becomes effective, based upon the nature of the certification relating to patents. Requires the Secretary to disapprove the application if it does not contain certain patent information, or to withdraw approval if the patent information was not filed within a specified time after notification. Requires that safety and effectiveness data be made available to the public, except as specified. Provides for the promulgation of regulations to administer the amendments made by this title. Restricts the dispensing of a toxic or harmful drug intended for animal use to those with a lawful written or oral order of a licensed veterinarian. Deems drugs otherwise dispensed to be misbranded. Title II: Patent Extension - Amends the patent laws to include animal drugs under the patent extension provisions applicable to human drugs which compensate for regulatory delays.

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• Introduced in House

  summary · EN · 26 May 1988

  Open at official source

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