FDA BRIEF: Week of January 16, 2017

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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  PeriodPublic 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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