§ 360dd. Open protocols for investigations of drugs for rare diseases or conditions

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1983

   Pub. L. 97–414 § 2(a) · 96 Stat. 2049

   Enacted · 21 U.S.C. § 360dd

   (June 25, 1938, ch. 675, § 528, as added Pub. L. 97–414, § 2(a), Jan. 4, 1983, 96 Stat. 2051.)

   Source evidence

   Code source credit
   (June 25, 1938, ch. 675, § 528, as added Pub. L. 97–414, § 2(a), Jan. 4, 1983, 96 Stat. 2051.)

   Enacted provision · exact public law section
   (a) Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end the following: “Subchapter B— Drugs for Rare Diseases or Conditions “Sec. 525. “recommendations for investigations of drugs for rare diseases or conditions (a) The sponsor of a drug for a disease or condition 21 USC 360aa. which is rare in the States may request the Secretary to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before— “(1) it may be approved for such disease or condition under section 505, or 21 USC 355. “(2) if the drug is a biological product, before it may be licensed for such disease or condition under section 351 of the 42 USC 262. Public Health Service Act. If the Secretary has reason to believe that a drug for which a request is made under this section is a drug for a disease or condition which is rare in the States, the Secretary shall provide the person making the request written recommendations for the non-clinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request under this section, would be necessary for approval of such 21 USC 355. drug for such disease or condition under section 505 or licensing under section 351 of the Public Health Service Act for such disease or condition. “(b) The Secretary shall by regulation promulgate procedures for the implementation of subsection (a). “Sec. 526. “designation of drugs for rare diseases or conditions (a) (1) The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare disease or condition. If the Secretary finds that a drug for which a request is submitted under this subsection is being or will be investigated for a rare disease or condition and— “(A) if an application for such drug is approved under section 505, or “(B) if the drug is a biological product, a license is issued under section 351 of the Public Health Service Act, the approval or license would be for use for such disease or condition, the Secretary shall designate the drug as a drug for such disease or condition. A request for a designation of a drug under this subsection shall contain the consent of the applicant to notice being given by the Secretary under subsection (b) respecting the designation of the drug. “(2) “Rare disease or condition.” For purposes of paragraph (1), the term ‘rare disease or condition’ means any disease or condition which occurs so infrequently in the United States that there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug. Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under this subsection is made. “(b) Notice. Notice respecting the designation of a drug under subsection (a) shall be made available to the public. “(c) The Secretary shall by regulation promulgate procedures for the implementation of subsection (a). “Sec. 527. “protection for unpatented 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(b), 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 Ante, p. 2050. condition and for which a United States Letter of Patent may not be issued, the Secretary may not approve another application under section 505(b) or issue another license under section 351 of the 21 USC 355. 42 USC 262. 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 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(b) is approved for a drug designated under section 526 for a rare disease or condition or a license is issued under section 351 of the Public Health Service Act for such a drug and if a United States Letter of Patent may not be issued for the 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(b), or, if the drug is a biological product, 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. “Sec. 528. “open protocols for investigations of drugs for rare diseases or conditions If a drug is designated under section 526 as a 21 USC 360dd. drug for a rare disease or condition and if notice of a claimed exemption under section 505(i) or regulations issued thereunder is filed for such drug, the Secretary shall encourage the sponsor of such drug to design protocols for clinical investigations of the drug which may be conducted under the exemption to permit the addition to the investigations of persons with the disease or condition who need the drug to treat the disease or condition and who cannot be satisfactorily treated by available alternative drugs.”.

1 of 1 references resolved to an enrolled provision