3-Hour Virtual Seminar on Off label Promotion of Drugs and Medical Devices - FDA's Latest

Overview:

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.

Why should you Attend: 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.

Areas Covered in the Session:
Session #: 1
Duration: 30 minutes
Learning Objectives: 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.

• 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
• Snake Oil Salesmen and the FDA
• FDA: between patients and industry
• Off-Label Promotions and First Amendment Issues
• Federal Register History of the current guidance documents

Session #: 2
Duration: 30 minutes
Learning Objectives: 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.

• Today's healthcare environment for patients
• Patient expectations
• FDA & Industry response
• How today's patient influences off-label promotion of medical products
• Patients' comments

BREAK -

Session #: 3
Duration: 30 minutes
Learning Objectives: 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.

• FDA Position
• Industry Position - Is the FDA Listening?
• Legal Considerations
• Where are we today?

Session #: 4
Duration: 30 minutes
Learning Objectives: 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.

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

BREAK -

Session #: 5
Duration: 30 minutes
Learning Objectives: 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.

• Introduction
• Background
• Questions & Answers

Session #: 6
Duration: 30 minutes
Learning Objectives: 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.

• Comments from Industry
• Comments from Health Care Providers
• Comments from Health Care Insurers
• Legal Considerations
• Future Expectations

Q&A

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 Will Benefit:

• Quality Managers
• Quality Engineers
• Regulatory Affairs
• Regulatory Attorneys
• Doctors
• Health Insurance
• Small Business Owners
• GxP
• Consultants
• Quality VPs
• IT VPs
• Lab Directors
• Scientists
• FDA Investigators
• Other Regulatory Agency Investigators
• Nurses
• First Amendment Lawyers
• Fifth Amendment Lawyers