21 U.S.C. § 360cc — Protection for drugs for rare diseases or conditions

(a) Exclusive approval, certification, or license. Except as subsection (b) allows, if the Secretary approves a drug application under section 355 of this title, or issues a biologics license under section 262 of title 42, for a drug designated under section 360bb of this title as treating a rare disease or condition, the Secretary may not approve or license another maker's version of that same drug for that same approved use within that rare disease, for a person who does not hold the original approval or license, until 7 years after the original approval or license. The usual right to a hearing on a refusal to approve under section 355(c)(2) of this title does not apply to a refusal made under this rule. (b) Exceptions. During that 7-year period, the Secretary may approve or license a drug that is otherwise the same as the already-approved drug, for the same use, if — (1) after giving the exclusivity holder notice and a chance to respond, the Secretary finds the holder cannot ensure enough of the drug is available to meet the needs of people with the disease or condition, or (2) the holder gives the Secretary written consent to approve or license others before the 7 years end. (c) Condition of clinical superiority (1) In general. If a sponsor's drug is designated under section 360bb of this title and is otherwise the same as an already-approved or licensed drug, and the sponsor is seeking exclusive approval or licensure under subsection (a) for the same use for which the already-approved drug was approved, the Secretary must require the sponsor, as a condition of that exclusivity, to show the new drug is "clinically superior" to the already-approved drug. (2) Definition. "Clinically superior" means the drug provides a significant therapeutic advantage over the already-approved or licensed drug — through greater effectiveness, greater safety, or a major contribution to patient care. (3) Applicability. This clinical-superiority requirement applies to any drug designated under section 360bb of this title for which an application was approved under section 355 of this title, or a license issued under section 262 of title 42, after August 18, 2017 — regardless of when the drug was originally designated. (d) Regulations. The Secretary may issue regulations to carry out subsection (c). Until new regulations are issued, beginning August 18, 2017, the Secretary may apply definitions from regulations that existed before that date, as long as they do not conflict with this section as amended. (e) Demonstration of clinical superiority standard. To help sponsors show clinical superiority, the Secretary must — (1) upon designating a drug under section 360bb of this title, notify the sponsor in writing of the basis for the designation, including any plausible theory the sponsor offered, and the Secretary relied on, that the drug is clinically superior to a previously approved drug; and (2) upon granting exclusive approval or licensure under subsection (a) based on a demonstration of clinical superiority, publish a summary of the clinical superiority findings. (f) Approved use or indication defined. In this section, "approved use or indication" means the use or indication approved under section 355 of this title, or licensed under section 262 of title 42, for a drug designated under section 360bb of this title as treating a rare disease or condition.