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:
- Guidance: Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities—Questions and Answers
- Guidance: Medical Product Communications That Are Consistent with the FDA-Required Labeling—Questions and Answers.
- 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.
- 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
- FDA Investigators
- Other regulatory agency investigators
- First Amendment Lawyers
- Fifth Amendment Lawyers
- Marketing Departments