Section 5 of Orphan Drug Act

 

GRANTS AND CONTRACTS FOR DEVELOPMENT OF DRUGS 
FOR RARE DISEASES AND CONDITIONS  1

 

SEC. 5. (a) [21 USC §360ee] The Secretary may make grants to and enter into contracts with public and private entities and individuals to assist in (1) defraying the costs of qualified testing expenses incurred in connection with the development of drugs for rare diseases and conditions, (2) defraying the costs of developing medical devices for rare diseases or conditions, and (3) defraying the costs of developing medical foods for rare diseases or conditions.

(b) For purposes of subsection (a):

(1) The term "qualified testing" means—

(A) human clinical testing—

(i) which is carried out under an exemption for a drug for a rare disease or condition under section505(i) of the Federal Food, Drug, and Cosmetic Act (or regulations issued under such section); and

(ii) which occurs after the date such drug is designated under section 526 of such Act and before the date on which an application with respect to such drug is submitted under section 505(b) of such Act or under section 351 of the Public Health Service Act; and

(B) preclinical testing involving a drug for a rare disease or condition which occurs after the date such drug is designated under section 526 of such Act and before the date on which an application with respect to such drug is submitted under section 505(b) of such Act or under section351 of the Public Health Service Act.

(2) The term "rare disease or condition" means (1)  2 in the case of a drug, any disease or condition which (A) 2 affects less than 200,000 persons in the United States, or (B) 2 affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drugs, (2) 2 in the case of a medical device, any disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that a medical device for such disease or condition will be developed without assistance under subsection (a), and (3) 2 in the case of a medical food, any disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that a medical food for such disease or condition will be developed without assistance under subsection (a). Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under section 526 of the Federal Food, Drug, and Cosmetic Act is made.

(3) The term "medical food" means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.

(c) For grants and contracts under subsection (a), there are authorized to be appropriated such sums as already have been appropriated for fiscal year 2002, and $25,000,000 for each of the fiscal years 2003 through 2006.

 

Footnotes

 

 1. Public Law 97–414.

 2. So in law. See section 3 of Public Law 100–290 (102 Stat. 90). In subsection (b)(2) above, the organizational units (1), (2), and (3) probably should be (A), (B), and (C) (and in the unit (1), (A) and (B) probably should be (i) and (ii)).