§ 360cc. Protection for drugs for rare diseases or conditions
(a)
Exclusive approval, certification, or license
Except as provided in subsection (b) of this section, 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 such drug for such 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) of this title does not apply to the refusal to approve an application under the preceding sentence.
(b)
Exceptions
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—
(1)
the Secretary finds, after providing the holder notice and opportunity for the submission of views, that in such period the holder of the approved application or of the license cannot assure 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