If a sponsor of a drug that is designated under section 360bb of this title 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.
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.
This subsection applies to any drug designated under section 360bb of this title for which an application was approved under section 355 of this title or licensed under section 262 of title 42 after
The Secretary may promulgate regulations for the implementation of subsection (c). Beginning on
Section 355(c)(2) of this title, referred to in subsec. (a), was redesignated as section 355(c)(1)(B) of this title by Pub. L. 98–417, title I, § 102(a)(2),
This section, as amended by such Act, referred to in subsec. (d), means this section as amended by the FDA Reauthorization Act of 2017, Pub. L. 115–52.
2020—Subsec. (c)(3). Pub. L. 116–260 added par. (3).
2017—Subsec. (a). Pub. L. 115–52, § 607(a)(1), substituted “the same drug for the same disease or condition” for “such drug for such disease or condition” in concluding provisions.
Subsec. (b). Pub. L. 115–52, § 607(a)(2)(A), in introductory provisions, substituted “During the 7-year period described in subsection (a) for an approved application under section 355 of this title or license under section 262 of title 42, 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” for “If an application filed pursuant to section 355 of this title is approved for a drug designated under section 360bb of this title for a rare disease or condition or if a license is issued under section 262 of title 42 for such a drug, the Secretary may, during the seven-year period beginning on the date of the application approval or of the issuance of the license, approve another application under section 355 of this title or issue a license under section 262 of title 42, for such drug for such disease or condition for a person who is not the holder of such approved application or of such license if”.
Subsec. (b)(1). Pub. L. 115–52, § 607(a)(2)(B), substituted “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” for “notice and opportunity for the submission of views, that in such period the holder of the approved application or of the license cannot assure”.
Subsec. (b)(2). Pub. L. 115–52, § 607(a)(2)(C), substituted “the holder provides” for “such holder provides”.
Subsecs. (c) to (e). Pub. L. 115–52, § 607(a)(3), added subsecs. (c) to (e).
2002—Subsec. (a). Pub. L. 107–281, in concluding provisions, struck out “, of such certification,” after “such approved application” and “, the issuance of the certification,” after “approval of the approved application”.
1997—Subsec. (a). Pub. L. 105–115, § 125(b)(2)(J), struck out “, issue another certification under section 357 of this title,” before “or issue another license” in closing provisions, inserted “or” at end of par. (1), redesignated par. (3) as (2), and struck out former par. (2) which read as follows: “issues a certification under section 357 of this title, or”.
Subsec. (b). Pub. L. 105–115, § 125(b)(2)(K), in introductory provisions, struck out “, if a certification is issued under section 357 of this title for such a drug,” after “rare disease or condition”, “, of the issuance of the certification under section 357 of this title,” after “application approval”, “, issue another certification under section 357 of this title,” after “application under section 355 of this title”, and “, of such certification,” after “approved application”.
Subsec. (b)(1). Pub. L. 105–115, § 125(b)(2)(K), struck out “, of the certification,” after “holder of the approved application”.
Subsec. (b)(2). Pub. L. 105–115, § 125(b)(2)(K), struck out “, issuance of other certifications,” after “approval of other applications”.
1993—Subsec. (b). Pub. L. 103–80 struck out extraneous comma before “or issue a license under section 262” in introductory provisions and substituted “the” for “The” at beginning of par. (1).
1985—Pub. L. 99–91, § 2(3), struck out “unpatented” before “drugs” in section catchline.
Subsec. (a). Pub. L. 99–91, §§ 2(1), 3(a)(3)(A)–(D), struck out “or” at end of par. (1), added par. (2), redesignated former par. (2) as (3), struck out “and for which a United States Letter of Patent may not be issued” after “rare disease or condition”, inserted in first sentence “, issue another certification under section 357 of this title,” after “section 355 of this title” the second time it appeared, inserted “, of such certification,” after “holder of such approved application”, and inserted “, the issuance of the certification,” after “approval of the approved application”.
Subsec. (b). Pub. L. 99–91, §§ 2(2), 3(a)(3)(E)–(K), struck out “and if a United States Letter of Patent may not be issued for the drug” after “such a drug”, substituted “, if a certification is issued under section 357 of this title for such a drug, or if a license” for “or a license”, inserted “, of the issuance of the certification under section 357 of this title,” after “application approval”, struck out “, if the drug is a biological product,” before “issue a license”, inserted “, issue another certification under section 357 of this title,” after “section 355 of this title”, inserted “, of such certification,” after “holder of such approved application”, inserted “, of such certification,” after “application” in par. (1), and inserted “, issuance of other certifications,” after “other applications” in par. (2).
1984—Subsecs. (a), (b). Pub. L. 98–417 substituted “section 355” for “section 355(b)” wherever appearing.
Amendment by Pub. L. 99–91 effective
Pub. L. 115–52, title VI, § 607(b),