Orphan Drug Amendments of 1992

Orphan Drug Amendments of 1992 - Amends provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) relating to designation of drugs for rare diseases or conditions to require that the number of people affected be determined three years after the request for designation as well as on the date of the request.

Increases the period during which the approval of an application, a certification, or a license for such a drug must be exclusive.

Creates additional exceptions from the protection of exclusive approval, certification, or license for drugs for rare diseases for drugs which qualified for protection because the disease or condition for which they are used affected less than a specified number of persons, but which have ceased to so qualify.

Provides for the termination of orphan drug status for drugs having cumulative sales over a certain amount, provided the costs of developing the drug in the United States are not over the same amount. Mandates a minimum two-year period after approval of an application, certification, or license before such a termination may be ordered. Sets forth transition rules requiring other minimum periods before such termination for drugs approved or awaiting approval at the time of enactment of this Act.

Amends the Public Health Service Act to replace provisions establishing the Orphan Products Board with provisions establishing the Office for Orphan Diseases and Conditions. Includes in the functions of the Office dealing with drugs, devices, and medical foods (currently, the Board deals with drugs and devices). Establishes an advisory committee within the Office.

Amends the FDCA to authorize appropriations for grants and contracts for development of drugs for rare diseases and conditions.