PUBLIC LAW 97-414—JAN. 4, 1983 Public Law 97-414 97th Congress
96 STAT. 2049
An Act
To amend the Federal Food, Drug, and Cosmetic Act to facilitate the development of drugs for rare diseases and conditions, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
Jan. 4, 1983 [H.R. 5238] Orphan Drug Act.
SHORT TITLE; F I N D I N G S
1. (a) This Act may be cited as the "Orphan Drug Act", 21 USC 301 note. 21 USC 360aa (b) The Congress finds that— (1) there are many diseases and conditions, such as Hunting- note. ton's disease, myoclonus, ALS (Lou Gehrig's disease), Tourette syndrome, and muscular dystrophy which affect such small numbers of individuals residing in the United States that the diseases and conditions are considered rare in the United States; (2) adequate drugs for many of such diseases and conditions have not been developed; (3) drugs for these diseases and conditions are commonly referred to as "orphan drugs"; (4) because so few individuals are affected by any one rare disease or condition, a pharmaceutical company which develops an orphan drug may reasonably expect the drug to generate relatively small sales in comparison to the cost of developing the drug and consequently to incur a financial loss; (5) there is reason to believe that some promising orphan drugs will not be developed unless changes are made in the applicable Federal laws to reduce the costs of developing such drugs and to provide financial incentives to develop such drugs; and (6) it is in the public interest to provide such changes and incentives for the development of orphan drugs. SECTION
AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
SEC. 2. (a) Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end the following: "SUBCHAPTER B—DRUGS FOR RARE DISEASES OR CONDITIONS RECOMMENDATIONS FOR INVESTIGATIONS OF DRUGS FOR RARE DISEASES OR CONDITIONS
"SEC. 525. (a) The sponsor of a drug for a disease or condition which is rare in the States may request the Secretary to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before— "(1) it may be approved for such disease or condition under section 505, or
21 USC 360aa.
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21 USC 355.
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