21 U.S.C. § 360bb — Designation of drugs for rare diseases or conditions

submitted 88 years ago by Pub. L. 97-414 to r/title-21-FOOD-AND-DRUGS · 526 words · no verdicts yet

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A drug company may ask the government to designate its drug as treating a rare disease or condition. It must grant this if fewer than 200,000 Americans have the disease. It also grants it for more common diseases if U.S. sales won't cover development costs.

(a) Request by sponsor; preconditions; "rare disease or condition" defined (1) A drug's manufacturer or sponsor may ask the Secretary to designate the drug as treating a rare disease or condition. This request must be made before filing a regular approval application under section 355(b), or a biologic license application under 42 U.S.C. 262. If the Secretary finds the drug is being studied, or will be studied, for a rare disease or condition, and that an approval or license eventually granted for it would cover that disease or condition, the Secretary must designate it. The request must include the applicant's consent to let the Secretary give notice of the designation under this section. (2) "Rare disease or condition" means a disease or condition that either (A) affects fewer than 200,000 people in the United States, or (B) affects more than 200,000 people, but there's no reasonable expectation that the cost of developing and marketing a drug for it in the United States would be recovered from U.S. sales of that drug. This is decided based on the facts as they stand on the date the designation request is filed. (b) Notification of discontinuance of drug or application as a condition A designation under (a) comes with strings attached. (1) If an application for the drug was approved under section 355(b), or a license was issued under 42 U.S.C. 262, the manufacturer must tell the Secretary at least one year before it stops producing the drug. (2) If the drug hasn't been approved or licensed yet, and preclinical studies or investigations under section 355(i) are underway, the manufacturer or sponsor must tell the Secretary if it decides to stop actively pursuing approval or licensing. (c) Notice to public The Secretary must make notice of a drug's rare-disease designation under (a) available to the public. (d) Regulations The Secretary must issue regulations setting out the procedures for carrying out (a).

the actual law source: uscode.house.gov ↗public domain

(a) Request by sponsor; preconditions; “rare disease or condition” defined

(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. A request for designation of a drug shall be made before the submission of an application under section 355(b) of this title for the drug, or the submission of an application for licensing of the drug under section 262 of title 42. 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 355 of this title, or

(B)

if a license for such drug is issued under section 262 of title 42,

the approval, certification, 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) 1 respecting the designation of the drug.

(2)

For purposes of paragraph (1), the term “rare disease or condition” means any disease or condition which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which 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) Notification of discontinuance of drug or application as condition

A designation of a drug under subsection (a) shall be subject to the condition that—

(1)

if an application was approved for the drug under section 355(b) of this title or a license was issued for the drug under section 262 of title 42, the manufacturer of the drug will notify the Secretary of any discontinuance of the production of the drug at least one year before discontinuance, and

(2)

if an application has not been approved for the drug under section 355(b) of this title or a license has not been issued for the drug under section 262 of title 42 and if preclinical investigations or investigations under section 355(i) of this title are being conducted with the drug, the manufacturer or sponsor of the drug will notify the Secretary of any decision to discontinue active pursuit of approval of an application under section 355(b) of this title or approval of a license under section 262 of title 42.

Notice respecting the designation of a drug under subsection (a) shall be made available to the public.

(d) Regulations

The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).

Source credit: (June 25, 1938, ch. 675, § 526, as added Pub. L. 97–414, § 2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98–551, § 4(a), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99–91, § 3(a)(2), Aug. 15, 1985, 99 Stat. 387; Pub. L. 100–290, § 2, Apr. 18, 1988, 102 Stat. 90; Pub. L. 105–115, title I, § 125(b)(2)(H), (I), Nov. 21, 1997, 111 Stat. 2326.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 97-414 · 96 Stat. 2050
1984Amended · Pub. L. 98-551 · 98 Stat. 2817
1985Amended · Pub. L. 99-91 · 99 Stat. 387
1988Amended · Pub. L. 100-290 · 102 Stat. 90
1997Amended · Pub. L. 105-115 · 111 Stat. 2326

A history note hasn’t been published yet. The record shows enactment by Pub. L. 97-414 on 1938-06-25.

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