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:
Why You Should Attend
- 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
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.
- 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