FDA remains a mysterious in its approach to off-label advertising and promotion. The development of a reasonable and coherent regulatory program seems beyond the FDA’s capacity. What seemed to work in the past does not keep pace with a person’s right to know. That approach runs counter to the FDA’s mantra of “transparency.” Breaking the ice is your job, otherwise, the FDA will freeze you in place. FDA’s regulation of off-label promotion and advertising has kept changing, especially so in the past year.
What FDA says is not acceptable to federal courts. Recent litigation opens the door for new sales and marketing possibilities, but you must use intelligent caution. Otherwise, the FDA may still pounce on you. That’s fine if you want to be the next test case in court. You need to be careful!
Attend this session to better understand FDA’s changes and rethinking in its approach to off-label promotion and advertising.
- Identify legal criteria that the federal judiciary uses to push back the FDA
- Learn how FDA is rethinking its approach and how not to be fooled by it
- Consider how will the new FDA commissioner may affect FDA’s policy on off-label promotion and advertising
- FDA’s legal goals
- FDA’s growing legal failures
- Policy development, tactics and inside hurdles under the Trump administration
- Practical approaches for sales and marketing staff
- Social media traps
- Regulatory Affairs Departments
- Product Development Managers
- Compliance Departments
- Marketing Departments
- FDA Consultants
- In-house Legal Counsel