21 U.S.C. § 356h — Competitive generic therapies

(a) In general. At the request of an applicant for a drug designated a "competitive generic therapy" under subsection (b), the Secretary may expedite development and review of an abbreviated new drug application for that drug under section 355(j). (b) Designation process. The applicant may request this designation, at the same time as, or any time before, submitting the abbreviated application under section 355(j). A drug qualifies for designation if the Secretary determines there is inadequate generic competition for it. Not later than 60 calendar days after the request, the Secretary may determine whether the drug meets that criteria, and if so, designate it as a competitive generic therapy. (c) Actions. To expedite development and review, at the applicant's request the Secretary may: hold meetings with the applicant and the review team throughout development, before the application is submitted; give timely, interactive advice on the drug's development to make the data-gathering process as efficient as practicable; involve senior managers and experienced review staff in a collaborative, coordinated review of the application, including for drug-device combination products and other complex products; and assign a cross-disciplinary project lead to facilitate an efficient review of the development program and application — including manufacturing inspections — and to serve as the scientific liaison between the review team and the applicant. (d) Reporting requirement. Not later than one year after the drug's application is approved, the sponsor must report to the Secretary on whether the drug has been marketed in interstate commerce since that approval. (e) Definitions. "Generic drug" means a drug approved under section 355(j). "Inadequate generic competition" means that, for a drug, not more than one approved drug on the list described in section 355(j)(7)(A) — not counting drugs on the discontinued section of that list — is either the reference listed drug, or a generic drug sharing that same reference listed drug. "Reference listed drug" means the listed drug (as that term is used in section 355(j)) for the drug involved.