MISCELLANEOUS PROVISIONS RELATING
TO ORPHAN DRUGS
Section 5 of the Orphan Drug Act¹
Grants and contracts for development of drugs for rare diseases and conditions
- (a) Authority of Secretary
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) Definitions
For purposes of subsection (a) of this section:
- (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 section 355(i) of
this title (or regulations issued under such section);
and
- (ii) which occurs after the date such drug is designated
under section 360bb of this title and before the date on
which an application with respect to such drug is submitted
under section 355(b) or 357 of this title or under section
262 of title 42; and
- (B) preclinical testing involving a drug for a rare disease
or condition which occurs after the date such drug is designated
under section 360bb of this title and before the date on which
an application with respect to such drug is submitted under section
355(b) or 357 of this title or under section 262 of title 42.
- (2) The term ''rare disease or condition'' means (1) in the case
of a drug, any disease or condition which (A) affects less than 200,000
persons in the United States, or (B) 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 drug, (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) of this section, and (3) 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) of this section. 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 360bb of this title 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) Authorization of appropriations
For grants and contracts under subsection (a) of this section there
are authorized to be appropriated $10,000,000 for fiscal year 1988, $12,000,000
for fiscal year 1989, (FOOTNOTE 1) $14,000,000 for fiscal year 1990.
(FOOTNOTE 1) So in original. Probably should be followed by ''and''.
¹Public Law 97-414; 21 USC 360ee
