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  4. Medical Countermeasures (MCMs)
  5. MCM Legal, Regulatory and Policy Framework
  6. Availability of Regulatory Management Plans
  1. MCM Legal, Regulatory and Policy Framework

Availability of Regulatory Management Plans

Section 565(f) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 360bbb–4(f))

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Introduction to RMPs

The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as amended by the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA), furthered FDA’s mission of fostering the development and availability of medical countermeasures (MCMs) by codifying the development of Regulatory Management Plans (RMPs) for certain high-priority MCMs.

Under section 565(f) of the FD&C Act, sponsors or applicants of eligible MCMs can request an RMP, setting forth a formal process for obtaining scientific feedback and agency interactions regarding the development and regulatory review of eligible MCMs. Eligible MCMs are those for which the Biomedical Advanced Research and Development Authority (BARDA) has:

  1. entered into a procurement contract under section 319F-2(c) of the Public Health Service (PHS) Act; or
  2. provided funding under section 319L of the PHS Act for advanced research and development.

Process for submission and timing of response

Sponsors or applicants of eligible MCMs may submit a request for an RMP after the eligible MCM has an investigational new drug (IND) or investigational device exemption (IDE) in effect. A request for an RMP should be submitted as a filing to the IND or IDE. 

Upon receipt of the request, FDA will work with the sponsor or applicant to agree on an RMP within a reasonable time not to exceed 90 days. If FDA determines that no plan can be agreed upon, FDA will provide to the sponsor or applicant, in writing, the scientific or regulatory rationale why such agreement cannot be reached.

Information required for submission of a request

Requests for an RMP that are submitted to FDA must include a proposed RMP with information sufficient to facilitate agreement. An agreed-upon RMP must include:

  1. an agreement between FDA and the sponsor or applicant regarding developmental milestones that will trigger FDA responses;
  2. performance targets and goals for timely and appropriate FDA responses, including meetings between FDA and the sponsor or applicant, written feedback, decisions by FDA, and other activities carried out as part of the development and review process; and
  3. an agreement on how to modify the plan, if needed.

Types of developmental milestones and performance targets

The developmental milestones and performance targets and goals within an RMP must include:

  1. feedback from FDA regarding the data required to support the approval, clearance, or licensure of the eligible MCM;
  2. feedback from FDA regarding the data necessary to inform any authorization for emergency use;
  3. feedback from FDA regarding the data necessary to support the positioning and delivery of the eligible MCM, including to the Strategic National Stockpile;
  4. feedback from FDA regarding the data necessary to support the submission of protocols for review;
  5. feedback from FDA regarding any gaps in scientific knowledge that will need resolution prior to approval, licensure, or clearance of the eligible MCM and plans for conducting the necessary scientific research;
  6. identification of the population for which the MCM sponsor or applicant seeks approval, licensure, or clearance and the population for which desired labeling would not be appropriate, if known; and
  7. as necessary and appropriate, and to the extent practicable, a plan for demonstrating safety and effectiveness in pediatric populations, and for developing pediatric dosing, formulation, and administration with respect to the eligible MCM, provided that such plan would not delay authorization for emergency use, approval, licensure, or clearance for adults.

MCMs eligible for RMPs

Under PAHPRA, MCMs eligible for RMPs are:

  • security countermeasures with respect to which the Secretary of HHS has entered into a procurement contract under section 319F-2(c) of the PHS Act (42 USCS § 247d-6b(c)); or
  • MCMs with respect to which the Biomedical Advanced Research and Development Authority (BARDA) has provided funding under section 319L of the PHS Act (42 USCS § 247d-7e) for advanced research and development. (FD&C Act Sec. 565(f); 21 U.S.C. § 360bbb-4(f)).

While RMPs are to be established for all security countermeasures for which they are requested, the Director of BARDA, in consultation with the FDA Commissioner, prioritizes which otherwise eligible MCMs may receive RMPs if resources are not available to establish RMPs for all eligible MCMs for which requests are submitted. (FD&C Act Sec. 565(f)(7); 21 U.S.C. § 360bbb-4(f))(7).

Contact information

To submit an RMP request, or for additional information related to the RMP request process, please contact your point of contact for the IND or IDE filing within the relevant Center or send an email to ORES@fda.hhs.gov.
 

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