FDA Views on Medical Product Communication – Drug and Device Digest

FDA BRIEF: Week of January 16, 2017

FDA Views on Medical Product Communication to Payors and to Public

Statement from FDA Commissioner Robert Califf, M.D.

• Addressing high level of interest regarding FDA’s views on medical product communications
• Ongoing dialogue with industry and other stakeholders
• Providing guidance to clarify the agency’s thinking

Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers

SCOPE

• Payors seek information on effectiveness, safety, cost-effectiveness for coverage and reimbursement
• Information can differ from submissions provided for FDA review
• Health Care Economic Information (HCEI) to payors – Economic consequences related to the clinical outcomes of treating /diagnosing/preventing disease
• Should be based on Competent and Reliable Scientific Evidence (CARSE)
•  Should be related to an approved indication – so not ‘false or misleading’

Q/A

• Communication of HCEI by Firms to Payors Regarding Approved Drugs
• Communications by Firms to Payors Regarding Investigational Drugs and Devices

Medical Product Communications that are Consistent with the FDA-required Labeling – Questions and Answers

SCOPE: FDA-required labeling

• Primary FDA tool to communicate essential information for safe and effective use
• Premarket Approval products: labeling reviewed and approved by FDA
• Premarket Notification products: also includes labeling to provide adequate directions for use and other important information

FACTORS to consider:

1. Comparison to conditions of use in FDA-required labeling: Indication, Patient Population, Limitations and Directions for Handling/Use, Dosing/Administration
2. Potential for harm to health relative to FDA-required labeling: Alter Benefit/Risk, Abuse/Misuse
3. Represent directions for use provided in FDA-required labeling:  To enable safe and effective product use

Q/A:

• Evidentiary support
• Recommendations for communicators
• Examples of consistency and inconsistency

Reopening Public Comment  Period : Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products

SCOPE:

• Reexamination of FDA rules and policies on communications on unapproved uses
• Integration of significant information
• Incorporation of input from two-day public hearing on November, 2016

CONSIDERATIONS:

Advancement of Public or Individual Health Interests:

• Motivating Development of Robust Scientific Data on Safety and Efficacy
• Preventing Public Harm- Fraud, Misrepresentation, Bias, Ineffective Treatments
• Ensuring Required Labeling is Accurate and Informative
• Protecting Integrity and Reliability of Promotional Information
• Protecting Human Subjects Receiving Experimental Treatments
• Protecting Innovation Incentives, Statutory Grants of Exclusivity
• Promoting Development of Products for Underserved Patients

How Communications on Unapproved Uses Can Advance Public or Individual Health Interests

• Supporting Informed Decision-Making for Patient Treatment
• Furthering Scientific Understanding and Research

Ensuring Policy to Maximize Public Good and Appropriate Consideration of First Amendment

• Evidence of “Intended Use”
• Commercial Speech under Central Hudson
• Content- and Speaker-Based Restrictions
• Alternative Approaches

Summary of Statutory and Regulatory Authorities: Human and Animal Drugs, Devices

Examples where Commonly Accepted Unapproved Uses have Led to Patient Harm: Erythropoiesis Stimulating Agents, Atypical Antipsychotics, Premarin/Prempro, Tambocor and Enkaid,

Examples of Products Marketed for Unapproved Uses that Caused Harm: Aranesp (Amgen), Seprafilm (Genzyme), Depakote (Abbott), Neurontin (Warner-Lambert), Atypical Antipsychotics (Eli Lilly, Bristol-Myers Squibb, Pfizer, AstraZeneca, Boehringer Ingelheim Vetmedica)

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