Marc Scheineson presented "Analyzing Post-Marketing Drug Safety Regulations and Manufacturers' Obligations under FDAAA" on October 23, from 8:45 a.m. - 9:45 a.m. at this conference coordinated by the American Conference Institute. The presentation covered the following topics:
• Examining Title IX of the FDA Amendments Act of 2007:
- When can the FDA require a REMS?
- REMS for products no longer on the market
- What types of obligations can the FDA impose on manufacturers?
• Defining Post-Marketing Requirement (PMR) and Post-Market Commitment (PMC) and making the distinction between the two:
- Understanding the purpose of a PMR and when the FDA can require one
- Recognizing the manufacturer’s obligations under a PMR and a PMC
• What is the precedential value of RiskMAPS if any?
• Identifying the different types of REMS and the elements/components of each:
- Timelines for assessing effectiveness
- Communications to patients and physicians
- Restrictions on distribution
• Requiring postmarket studies of drug safety concerns and drug labeling changes when new
drug safety information is identified
• Ensuring that the benefits of a drug or biological product outweigh its risks
• Understanding the FDA’s Sentinel safety surveillance network that will impact labeling
• Minimizing the potential for monetary penalties for violating REMS requirements
October 22-24, 2012
The Union League/ Philadelphia, PA