Hemin and chenodiol were the first two orphan drugs recognized under the 1983 Act.

Drug responsibilities increased in several ways in the mid-1980s. The Orphan Drug Act of 1983 employed several means to promote development of products for rare diseases. Among the provisions of this law, the sponsors of drug candidates could petition the agency for assistance in planning animal and clinical protocols. Also, the sponsor was allowed seven years of marketing protection for unpatentable products, and the law provided a 50 percent tax credit for investigation expenses. As a result of this Act, in early 1983 an Orphan Product Development office was established in the Office of the Commissioner, under Marion Finkel. Also in 1983, Congress passed the Federal Anti-Tampering Act in the wake of the Tylenol poisonings. This law amended the U.S. Code to provide penalties for tampering with or threatening to tamper with any product covered by the Food, Drug, and Cosmetic Act.