Sec. 607. ORPHAN DRUGS
635 words·~3 min read·
/statute-compilations/comps-15234/sec-607A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## SEC. 607 ORPHAN DRUGS ###
(a)In general Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— ####
(1)in subsection (a), in the matter following paragraph (2), by striking “such drug for such disease or condition” and inserting “the same drug for the same disease or condition”; ####
(2)in subsection (b)— #####
(A)in the matter preceding paragraph (1), by striking “If an application” and all that follows through “such license if” and inserting “During the 7-year period described in subsection
(a)for an approved application under section 505 or license under section 351 of the Public Health Service Act, the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if”; #####
(B)in paragraph (1), by striking “notice” and all that follows through “assure” and inserting “of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure”; and #####
(C)in paragraph (2), by striking “such holder provides” and inserting “the holder provides”; and ####
(3)by adding at the end the following: > > ### “(c) Condition of Clinical Superiority > > > #### “(1) In general > > If a sponsor of a drug that is designated under section 526 and is otherwise the same, as determined by the Secretary, as an already approved or licensed drug is seeking exclusive approval or exclusive licensure described in subsection
(a)for the same rare disease or condition as the already approved drug, the Secretary shall require such sponsor, as a condition of such exclusive approval or licensure, to demonstrate that such drug is clinically superior to any already approved or licensed drug that is the same drug. > > > #### “(2) Definition > > For purposes of paragraph (1), the term ‘clinically superior’ with respect to a drug means that the drug provides a significant therapeutic advantage over and above an already approved or licensed drug in terms of greater efficacy, greater safety, or by providing a major contribution to patient care. > > > ### “(d) Regulations > > The Secretary may promulgate regulations for the implementation of subsection (c). Beginning on the date of enactment of the FDA Reauthorization Act of 2017, until such time as the Secretary promulgates regulations in accordance with this subsection, the Secretary may apply any definitions set forth in regulations that were promulgated prior to such date of enactment, to the extent such definitions are not inconsistent with the terms of this section, as amended by such Act. > > > ### “(e) Demonstration of Clinical Superiority Standard > > To assist sponsors in demonstrating clinical superiority as described in subsection (c), the Secretary— > > > #### “(1) > > upon the designation of any drug under section 526, shall notify the sponsor of such drug in writing of the basis for the designation, including, as applicable, any plausible hypothesis offered by the sponsor and relied upon by the Secretary that the drug is clinically superior to a previously approved drug; and > > > #### “(2) > > upon granting exclusive approval or licensure under subsection
(a)on the basis of a demonstration of clinical superiority as described in subsection (c), shall publish a summary of the clinical superiority findings.” > . ###
(b)Rule of Construction **[**[21 U.S.C. 360cc note](/us/usc/t21/s360cc)**]** Nothing in the amendments made by subsection
(a)shall affect any determination under sections 526 and 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb, 360cc) made prior to the date of enactment of the FDA Reauthorization Act of 2017.
Connectionstraces to 2
Traces to 2 documents
Citation graph
cites case law
Cites 2Cited by 0 across 0 sources