Exclusive approval, certification, or license
Except as provided in subsection (b), if the Secretary—
for a drug designated under section 360bb of this title
for a rare disease or condition, the Secretary may not approve another application under section 355 of this title
or issue another license under section 262 of title 42
for the same drug for the same disease or condition for a person who is not the holder of such approved application or of such license until the expiration of seven years from the date of the approval of the approved application or the issuance of the license. Section 355(c)(2)
See References in Text note below.
of this title does not apply to the refusal to approve an application under the preceding sentence.
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—
the Secretary finds, after providing the holder 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 the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated; or
the holder provides the Secretary in writing the consent of such holder for the approval of other applications or the issuance of other licenses before the expiration of such seven-year period.
Demonstration of clinical superiority standard
To assist sponsors in demonstrating clinical superiority as described in subsection (c), the Secretary—
upon the designation of any drug under section 360bb of this title
, 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
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.
[June 25, 1938, ch. 675, § 527], as added [Pub. L. 97–414, § 2(a)], Jan. 4, 1983, [96 Stat. 2050]; amended [Pub. L. 98–417, title I, § 102(b)(6)], Sept. 24, 1984, [98 Stat. 1593]; [Pub. L. 99–91], §§ 2, 3(a)(3), Aug. 15, 1985, [99 Stat. 387], 388; [Pub. L. 103–80, § 3(v)], Aug. 13, 1993, [107 Stat. 778]; [Pub. L. 105–115, title I, § 125(b)(2)(J)], (K), Nov. 21, 1997, [111 Stat. 2326]; [Pub. L. 107–281, § 4], Nov. 6, 2002, [116 Stat. 1993]; [Pub. L. 115–52, title VI, § 607(a)], Aug. 18, 2017, [131 Stat. 1049]; [Pub. L. 116–260, div. BB, title III, § 323], Dec. 27, 2020, [134 Stat. 2933].)