3-Hour Virtual Seminar on Off Label Promotion for Drugs and Medical Devices

FDA and industry have struggled for the past 10 years, with the question of how FDA can reconcile its mission to protect public health by ensuring that medical products distributed in the United States are safe and effective for their intended use, with the fact that there is both a public health imperative and a constitutional right for manufacturers of those products to share truthful and non-misleading information about those products with the public.

In the area of off-label information, there is a tension that arises from the fact that, while products are approved by FDA for specific uses, physicians are permitted to prescribe medical products for uses that are not approved by FDA; in some cases, those unapproved uses are the standard of care. Similarly, payors are permitted – and in some cases required – to provide reimbursement for uses that FDA has not approved. Therefore, payors and healthcare providers require access to reliable information about these unapproved uses in order to make informed coverage and treatment decisions.

Court Cases citing First Amendment and Fifth Amendment rights have been discussed
To resolve this conundrum, the agency introduced 2 new guidance documents and a memorandum:

  1. Guidance: Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities—Questions and Answers
  2. Guidance: Medical Product Communications That Are Consistent with the FDA-Required Labeling—Questions and Answers.
  3. Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products

FDA invited comments concerning their comprehensive review of the regulations and policies governing manufacturer communications regarding unapproved uses of approved or cleared medical products.

Why You Should Attend:

Off Label Promotion for Drugs and Medical Devices is a controversial topic which often puts FDA and industry at loggerheads. FDA continues to need to ensure public health by protect public health by ensuring that medical products distributed in the United States are safe and effective for their intended use while industry believes that safe and effective off label use is warranted. It is further complicated by today’s patient who is much more savvy with regards to treatment and sometimes demands off-label use of products.

This class presents the latest FDA, industry & patient thinking to assist manufacturers in enhancing the predictability, consistency, and transparency of off-label promotion of medical products, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision. The views of FDA, industry and patients will be presented and the latest concurrences and issues will be described.

Learning Objectives:

  • Context of the Off-Label Promotion Decisions
  • Patients’ Expectations
  • FDA Position
  • Industry Position
  • Legal Considerations
  • FDA Guidance Documents
  • Current state of the decision and expectations for the future

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Compliance Departments
  • Regulatory Affairs Departments
  • Engineering Departments
  • Operations Departments
  • Regulatory Attorneys
  • Health Insurance
  • Small business owners
  • GxP Consultants
  • Directors and VPs
  • Scientists
  • FDA Investigators
  • Other regulatory agency investigators
  • Doctors
  • Nurses
  • First Amendment Lawyers
  • Fifth Amendment Lawyers
  • Marketing Departments

FDB3685

Angela Bazigos

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences.

Session 1:

This session sets the context for the off-label promotion of medical products starting with early history and moving to the most recent history of FDA’s decision on guidance documents

  1. Early History of Off-Label Promotion of medical products including some common household products such as Listerine and Ketchup that were originally used for patient treatment
  2. Snake Oil Salesmen and the FDA
  3. FDA: between patients and industry
  4. Off-Label Promotions and First Amendment Issues
  5. Federal Register History of the current guidance documents

Session 2:

As explained in the previous session FDA is always balancing the needs of the patient against the demands of the industry. Today’s patients create additional issues for FDA and industry in that they bear a materially higher burden of medical payments plus have access to online tools. These make today’s patient much more demanding with their treatment and requests for off-label use of medical products.

  1. Today’s healthcare environment for patients
  2. Patient expectations
  3. FDA & Industry response
  4. How today’s patient influences off-label promotion of medical products
  5. Patients’ comments

Session 3:

This session will describe the issues that FDA and industry face in making the decisions re off-label promotion of medical products. It will present each side of the equation and will include First Amendment and Fifth Amendment Issues. Court hearings on the subject will be presented.

  1. FDA Position
  2. Industry Position – Is the FDA Listening?
  3. Legal Considerations
  4. Where are we today?

Session 4:

This session will discuss the guidance “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities” which explains the FDA’s current thinking and recommendations on firms’ communication of health care economic information (HCEI) about approved drugs under section 502(a) of the FD&C Act, which was recently amended by the 21st Century Cures Act. It also answers common questions and provides the FDA’s recommendations regarding firms’ communications to payors about investigational drugs and devices that are not yet approved or cleared for any use.

  1. Introduction
  2. Background
  3. Questions & Answers
    • Communication of HCEI by Firms to Payors Regarding Approved Drugs
    • Communications by Firms to Payors Regarding Investigational Drugs and Devices

Session 5:

This session will discuss the guidance “Medical Product Communications That Are Consistent With the FDA-Required Labeling ” which explains the FDA’s current thinking about firms’ medical product communications that include data and information that are not contained in their products’ FDA-required labeling, but that concern the approved or cleared uses of their products.

  1. Introduction
  2. Background
  3. Questions & Answers

Session 6:

This session will discuss comments from industry, health care providers, health care insurers and other concerned parties. The latest legal considerations, decisions and conclusions will be discussed as well as future expectations for off-label promotion of medical products.

  1. Comments from Industry
  2. Comments from Health Care Providers
  3. Comments from Health Care Insurers
  4. Legal Considerations
  5. Future Expectations
Refund Policy

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance