Description
This guidance provides answers to common questions regarding firms’ communication of health care economic information (HCEI) regarding their prescription drugs and medical devices to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis (collectively referred to as payors). This guidance also addresses common questions relating to dissemination to payors of information about medical products that are not yet approved or cleared for any use and dissemination to payors of information about unapproved uses of approved/cleared medical products.
Scope & Applicability
Product Classes
4Human prescription drugs including biological products
medical products that have not yet received FDA approval, clearance, or licensure
Medical devices intended for human use; Approved or cleared medical devices
Products for which HCEI may be communicated under section 502(a).
Stakeholders
4Entities with knowledge and expertise in health care economic analysis; Sophisticated audience including public and private sector entities responsible for financing health care costs.; Entities such as formulary committees that receive HCEI for coverage decisions.; Entities such as formulary committees receiving HCEI; entities such as formulary committees that receive health care economic information
drug and device manufacturers communicating with payors
Entities carrying out responsibilities for selection of drugs for coverage
Entity responsible for submitting NDINs
Regulatory Context
Attributes
3HCEI must relate to the disease or condition for which the drug is indicated.
Evidence of a new intended use based on communications
Applicability of HCEI from one health care setting to another.
Identified Hazards
Hazards
1Potential biases from funding or drafting underlying research.
Related CFR Sections (6)
- 21CFR812.7§ 812.7 Prohibition of promotion and other practices.
A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:Read full regulation →
- 21CFR312.7§ 312.7 Promotion of investigational drugs.
(a) Promotion of an investigational new drug. A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise pRead full regulation →
- 21CFR601.45§ 601.45 Promotional materials.
For biological products being considered for approval under this subpart, unless otherwise informed by the agency, applicants must submit to the agency for consideration during the preapproval review period copies of all promotional materials, including promotional labeling as well as advertisementsRead full regulation →
- 21CFR314.550§ 314.550 Promotional materials.
For drug products being considered for approval under this subpart, unless otherwise informed by the agency, applicants must submit to the agency for consideration during the preapproval review period copies of all promotional materials, including promotional labeling as well as advertisements, inteRead full regulation →
- 21CFR1.3§ 1.3 Definitions.
(a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce.Read full regulation →
- 21CFR314.81§ 314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →
Related Warning Letters (2)
- 2025-09-16
False & Misleading Claims/Misbranded
Aytu Biopharma
- 2022-02-22
New Drug/Labeling/Misbranded
CytoDyn, Inc.
See Also (8)
- Exception from Informed Consent Requirements for Emergency Research: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors (Status: Final)
- Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers (Status: Final)
- Expedited Programs for Serious Conditions | Drugs and Biologics (Status: Final)
- Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (Status: Final)
- Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers (Status: Draft)
- Accelerated Approval – Expedited Program for Serious Conditions (Status: Draft)