RARE Act

Bill: 118-s-1214
Sponsor: full_name: Sen. Baldwin, Tammy [D-WI]
Introduced: 2023-04-19
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Drug therapy

Licensing and registrations

Prescription drugs
Latest action: action_date: 2023-06-22
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 109.

Summaries:
action_date: 2023-04-19
action_desc: Introduced in Senate
text: <p><b>Retaining Access and Restoring Exclusivity Act or the RARE Act</b></p> <p>This bill specifies that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drug exclusivity period) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition.</p> <p>Current law grants a seven-year period of market exclusivity for an approved orphan drug, during which the Food and Drug Administration (FDA) may not approve an application from another manufacturer for the same drug for the same disease or condition. The FDA's regulations provide that this exclusivity is specific to the same approved use or indication of the drug, rather than all uses or indications, for the disease or condition. However, in <i>Catalyst Pharmaceuticals, Inc. v. Becerra, </i>a court held that exclusivity did extend to all uses or indications for the disease or condition.</p> <p>The bill provides statutory authority for the FDA's regulations. </p>

action_date: 2023-06-22
action_desc: Reported to Senate
text: <p><b>Retaining Access and Restoring Exclusivity Act or the RARE Act</b></p> <p>This bill specifies that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drug exclusivity period) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition.</p> <p>Current law grants a seven-year period of market exclusivity for an approved orphan drug, during which the Food and Drug Administration (FDA) may not approve an application from another manufacturer for the same drug for the same disease or condition. The FDA's regulations provide that this exclusivity is specific to the same approved use or indication of the drug, rather than all uses or indications, for the disease or condition. However, in <i>Catalyst Pharmaceuticals, Inc. v. Becerra, </i>a court held that exclusivity did extend to all uses or indications for the disease or condition.</p> <p>The bill provides statutory authority for the FDA's regulations. </p>

tv_txt: II Calendar No. 109 118th CONGRESS 1st Session S. 1214 IN THE SENATE OF THE UNITED STATES April 19, 2023 Ms. Baldwin (for herself and Mr. Braun ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions June 22, 2023 Reported by Mr. Sanders , without amendment A BILL To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions.

1. Short title This Act may be cited as the Retaining Access and Restoring Exclusivity Act or the RARE Act . 2. Limitations on exclusive approval or licensure of orphan drugs (a) In general Section 527 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ) is amended— (1) in subsection (a), in the matter following paragraph (2), by striking same disease or condition and inserting same approved use or indication within such rare disease or condition ; (2) in subsection (b)— (A) in the matter preceding paragraph (1), by striking same rare disease or condition and inserting same approved use or indication for which such 7-year period applies to such already approved or licensed drug ; and (B) in paragraph (1), by inserting , relating to the approved use or indication, after the needs ; (3) in subsection (c)(1), by striking same rare disease or condition as the already approved drug and inserting same use or indication for which the already approved or licensed drug was approved or licensed ; and (4) by adding at the end the following: (f) Approved use or indication defined In this section, the term approved use or indication means the use or indication approved under section 505 of this Act or licensed under section 351 of the Public Health Service Act for a drug designated under section 526 for a rare disease or condition. . (b) Application of amendments The amendments made by subsection (a) shall apply with respect to any drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb ), regardless of the date on which the drug was so designated, and regardless of the date on which the drug was approved under section 505 of such Act ( 21 U.S.C. 355 ) or licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ).

June 22, 2023 Reported without amendment

tv_txt: II 118th CONGRESS 1st Session S. 1214 IN THE SENATE OF THE UNITED STATES April 19, 2023 Ms. Baldwin introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions.

1. Short title This Act may be cited as the Retaining Access and Restoring Exclusivity Act or the RARE Act . 2. Limitations on exclusive approval or licensure of orphan drugs (a) In general Section 527 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ) is amended— (1) in subsection (a), in the matter following paragraph (2), by striking same disease or condition and inserting same approved use or indication within such rare disease or condition ; (2) in subsection (b)— (A) in the matter preceding paragraph (1), by striking same rare disease or condition and inserting same approved use or indication for which such 7-year period applies to such already approved or licensed drug ; and (B) in paragraph (1), by inserting , relating to the approved use or indication, after the needs ; (3) in subsection (c)(1), by striking same rare disease or condition as the already approved drug and inserting same use or indication for which the already approved or licensed drug was approved or licensed ; and (4) by adding at the end the following: (f) Approved use or indication defined In this section, the term approved use or indication means the use or indication approved under section 505 of this Act or licensed under section 351 of the Public Health Service Act for a drug designated under section 526 for a rare disease or condition. . (b) Application of amendments The amendments made by subsection (a) shall apply with respect to any drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb ), regardless of the date on which the drug was so designated, and regardless of the date on which the drug was approved under section 505 of such Act ( 21 U.S.C. 355 ) or licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ).