FDLI

About This Monograph

Prior to 2012, FDLI published the FDLI Monograph Series, which consisted of six monographs annually. We now publish 4 to 6 Primers each year.

In 2009, the Food and Drug Administration (FDA) issued landmark guidance on Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications. The guidance provided a general roadmap on compliance, but many undefined and controversial issues remain as FDA continues to construct a final guidance most likely to be issued during 2011. This Monograph provides a comprehensive look at various risk management topics, providing a comprehensive analysis and guidance from both FDA’s and industry’s perspective. FDA’s expanding authority to enforce REMS has the potential to drastically change the way manufacturers do business, and this Monograph includes how REMS affects a company’s ability to most effectively market medical products.

FDA can make use of the Park doctrine and Responsible Corporate Officer doctrine when enforcing REMS, so it is important that everyone involved in the drug production process is familiar with the regulations in order to avoid Warning Letters, debarment, fines or criminal charges. This Monograph provides you with the nuts and bolts of REMS compliance, covering everything from the history of REMS to risks of non-compliance. The new corporate and personal liabilities of non-compliance include:

1. Civil monetary penalties (CMPs) up to $250,000 per violation or $10 million for all violations in a single proceeding;
2. Declaration of drug misbranding;
3. Inability to introduce a drug into interstate commerce;
4. Misdemeanor or felony criminal sanctions;
5. Warning Letters;
6. Applications integrity policy (AIP) use allowing FDA to withhold actions on other pending applications;
7. Debarment to exclude companies and individuals from participation in FDA-regulated activities;
8. Exclusion from federal healthcare programs; and
9. Loss of trust from the public and shareholders.

After reading this Monograph, you will be better able to:

1. Effectively comply with REMS—from proposed REMS submission to final approval—and everything in between in dealing with FDA.
2. Understand legal issues involved in REMS compliance, including critical issues in the approval process.
3. Understand how REMS affects the drug development process and a sponsor’s bottom line.