21 U.S.C. § 356d

Current through P.L. 118-106 (published on www.congress.gov on 10/04/2024)

Section 356d - Coordination; task force and strategic plan

(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

(B) submit such plan to Congress.

(b) Communication

The Secretary shall ensure that, prior to any enforcement action or issuance of a warning letter that the Secretary determines could reasonably be anticipated to lead to a meaningful disruption in the supply in the United States of a drug described under section 356c(a) of this title, there is communication with the appropriate office of the Food and Drug Administration with expertise regarding drug shortages regarding whether the action or letter could cause, or exacerbate, a shortage of the drug.

(c) Action

If the Secretary determines, after the communication described in subsection (b), that an enforcement action or a warning letter could reasonably cause or exacerbate a shortage of a drug described under section 356c(a) of this title, then the Secretary shall evaluate the risks associated with the impact of such shortage upon patients and those risks associated with the violation involved before taking such action or issuing such letter, unless there is imminent risk of serious adverse health consequences or death to humans.

(d) Reporting by other entities

The Secretary shall identify or establish a mechanism by which health care providers and other third-party organizations may report to the Secretary evidence of a drug shortage.

(e) Review and construction

No determination, finding, action, or omission of the Secretary under this section shall-

(1) be subject to judicial review; or

(2) be construed to establish a defense to an enforcement action by the Secretary.

(f) Temporary sunset

Subsection (a) shall cease to be effective on the date that is 5 years after July 9, 2012. Subsections (b), (c), and (e) shall not be in effect during the period beginning 5 years after July 9, 2012, and ending on December 29, 2022. Subsections (b), (c), and (e) shall be in effect beginning on December 29, 2022.

(g) Coordination

The Secretary shall ensure timely and effective internal coordination and alignment among the field investigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research's Office of Compliance and Drug Shortage Program regarding-

(1) the reviews of reports shared pursuant to section 374(b)(2) of this title; and

(2) any feedback or corrective or preventive actions in response to such reports.

21 U.S.C. § 356d

June 25, 1938, ch. 675, §506D, as added Pub. L. 112-144, title X, §10031003,, 126 Stat. 1103; amended Pub. L. 117-328 div. FF, title III, §3616(a), Dec. 29, 2022, 136 Stat. 5874.

EDITORIAL NOTES

AMENDMENTS2022-Subsec. (f). Pub. L. 117-328, §3616(a)(2), amended subsec. (f) generally. Prior to amendment, text read as follows: "Subsections (a), (b), (c), and (e) shall cease to be effective on the date that is 5 years after July 9, 2012."Subsec. (g). Pub. L. 117-328, §3616(a)(1), added subsec. (g).