SEC. 527. [21 USC §360cc] Protection for Drugs for Rare Diseases or Conditions

(a) Except as provided in subsection (b), if the Secretary—

(1) approves an application filed pursuant to section 505, or

(2) issues a license under section 351 of the Public Health Service Act for a drug designated under section 526 for a rare disease or condition, the Secretary may not approve another application under section 505 or issue another license under section 351 of the Public Health Service Act for such drug for such disease or condition for a person who is not the holder of such approved application, of 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 505(c)(2) does not apply to the refusal to approve an application under the preceding sentence.

 

(b) If an application filed pursuant to section 505 is approved for a drug designated under section 526 for a rare disease or condition or if a license is issued under section 351 of the Public Health Service Act 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 505 or issue a license under section 351 of the Public Health Service Act, 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

(2) such 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.