Off Label Promotion for Drugs & Medical Devices Virtual Boot Camp
Off Label Promotion for Drugs & Medical Devices
Virtual Boot Camp
Presented By: Angela Bazigos
Date: Tuesday, February 27, 2018 | Duration: 180 minutes
Time: 1:00 PM ET – 4:15 PM ET
Register Now
Overview:
The FDA and the medical products industry have struggled for the past 10 years, with the question of how the FDA can reconcile its mission to protect public health. To achieve that goal, the FDA plans on ensuring that the medical products being distributed in the United States are safe and effective for their intended use, with 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, an area of tension is that, while products are approved by the FDA for specific uses, physicians are permitted to prescribe medical products for uses that are not approved by the 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 the 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.

To resolve this conundrum, the agency introduced two new guidance documents and a memorandum:
  • FDA’s Guidance: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers
  • FDA’s Guidance: Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers
  • FDA’s Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products

Why You Should Attend

Off-label promotion of drugs and medical devices often puts the FDA and the industry at loggerheads. It is further complicated by today’s patient, who is savvier regarding the treatment and sometimes demands off-label use of products.

Join this virtual boot camp, where expert Angela Bazigos will present the latest FDA, industry and patient thinking to assist manufacturers in enhancing the transparency, consistency and predictability of off-label promotion of medical products. This boot camp will describe in detail the regulatory framework, policies, and practices underlying such a decision. It will further describe the views of the FDA, industry and patients, and the latest concurrences and issues.

Session Objectives

  • Context of the off-label promotion decisions
  • Patients’ expectations for off-label use of medical products
  • FDA’s position on off-label use of medical products
  • Industry’s position on off-label use of medical products
  • Legal considerations regarding off-label use of medical products
  • FDA guidance documents on off-label use of medical products
  • Current state of the decision and expectations for the future regarding off-label use of medical products
Session Details
Session 1: Early and most recent history of Off-label

Length: 30 minutes | Time: 1:00 PM ET to 1:30 PM ET

This session will set 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.
Session 2: FDA’s response to patient expectations of Off-label

Length: 30 minutes | Time: 1:30 PM ET to 2:00 PM ET

The FDA is always balancing patients’ needs against the demands of the industry. Today, patients create additional issues for the FDA and industry as they bear a materially higher burden of medical payments and have access to online tools. These make today’s patients more demanding with their treatment and requests for off-label use of medical products. This session will discuss the expectations of today’s patients regarding the off-label use of medical products. It will further discuss the response of the FDA and industry to those expectations.
Session 3: Off-label promotions - Legal considerations

Length: 30 minutes | Time: 2:00 PM ET – 2:30 PM ET

This session will describe the issues that the FDA and industry face in making decisions regarding off-label promotion of medical products. The session will present each side of the equation, including First Amendment and Fifth Amendment issues, and court hearings on the subject.
Break Time: 2:30 PM ET – 2:45 PM ET | Duration: 15 minutes
Session 4: FDA’s guidance discussions - Part I

Length: 30 minutes | Time: 2:45 PM ET – 3:15 PM ET

This session will discuss the FDA’s guidance, “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities.” The guidance 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 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.
Session 5: FDA’s guidance discussions - Part II

Length: 30 minutes | Time: 3:15 PM ET – 3:45 PM ET

This session will discuss the FDA’s guidance, “Medical Product Communications that are Consistent with the FDA-Required Labeling.” The guidance explains the FDA’s current thinking about firms’ medical product communications. These communications 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.
Session 6: Off-label promotions - Future expectations

Length: 30 minutes | Time: 3:45 PM ET – 4:15 PM ET

This session will provide an account of the comments from industry, health care providers, health care insurers and other concerned parties for off-label promotion of medical products. The session will further discuss latest legal considerations, decisions and conclusions, as well as future expectations for off-label promotion of medical products.
Who Will Benefit?
  • Quality managers
  • Quality engineers
  • Regulatory affairs personnel
  • Regulatory attorneys
  • Doctors
  • Nurses
  • Health insurance personnel
  • Small business owners
  • GxP practitioners
  • Consultants
  • Quality VPs
  • IT VPs
  • Lab directors
  • Scientists
  • FDA investigators
  • Other regulatory agency investigators
  • First amendment lawyers
  • Fifth amendment lawyers
About Our Speaker
Angela BazigosAngela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Her experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development.
Register Now