21 U.S.C. § 356d Coordination; Task Force and Strategic Plan

• Library: United States Statutes
• Edition: prefLabel,label,title,shortLabel
• Currency: Current through P.L. 118-19 (published on www.congress.gov on 10/06/2023)
• Citation: 21 U.S.C. § 356d

(a) Task force and strategic plan

(1) In general

(A) Task force

As soon as practicable after July 9, 2012, the Secretary shall establish a task force to develop and implement a strategic plan for enhancing the Secretary's response to preventing and mitigating drug shortages.

(B) Strategic plan

The strategic plan described in subparagraph (A) shall include-

(i) plans for enhanced interagency and intra-agency coordination, communication, and decisionmaking;

(ii) plans for ensuring that drug shortages are considered when the Secretary initiates a regulatory action that could precipitate a drug shortage or exacerbate an existing drug shortage;

(iii) plans for effective communication with outside stakeholders, including who the Secretary should alert about potential or actual drug shortages, how the communication should occur, and what types of information should be shared;

(iv) plans for considering the impact of drug shortages on research and clinical trials; and

(v) an examination of whether to establish a "qualified manufacturing partner program", as described in subparagraph (C).

(C) Description of program

In conducting the examination of a "qualified manufacturing partner program" under subparagraph (B)(v), the Secretary-

(i) shall take into account that-

(I) a "qualified manufacturer", for purposes of such program, would need to have the capability and capacity to supply products determined or anticipated to be in shortage; and

(II) in examining the capability and capacity to supply products in shortage, the "qualified manufacturer" could have a site that manufactures a drug listed under section 356e of this title or have the capacity to produce drugs in response to a shortage within a rapid timeframe; and

(ii) shall examine whether incentives are necessary to encourage the participation of "qualified manufacturers" in such a program.

(D) Consultation

In carrying out this paragraph, the task force shall ensure consultation with the appropriate offices within the Food and Drug Administration, including the Office of the Commissioner, the Center for Drug Evaluation and Research, the Office of Regulatory Affairs, and employees within the Department of Health and Human Services with expertise regarding drug shortages. The Secretary shall engage external stakeholders and experts as appropriate.

(2) Timing

Not later than 1 year after July 9, 2012, the task force shall-

(A) publish the strategic plan described in paragraph (1); and