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.

The Food and Drug Administration (FDA) exercises broad powers to adopt rules and render decisions governing the business operations of regulated companies.

Because FDA's activities invariably affect both consumers and regulated companies, there are strong incentives, and seemingly limitless opportunities, for interested parties to seek to influence the agency's policy decisions and specific regulatory actions. And, where a company disagrees with, or would be harmed by, an FDA policy or action, there are various ways to challenge and seek to overturn the agency's decision.

The first half of this Monograph provides basic guidelines for Citizen Petitions and a behind-the-scenes look at how FDA deals with them once submitted. The second half deals with litigation against FDA.

The Monograph contains important Practice Notes on a variety of issues:

1. Protecting personal and trade information in petitions and comments;
2. Using the internet to keep up with petitions and regulatory documents;
3. Speaking with agency personnel about petition status;
4. Supplementing submitted petitions;
5. Complaint letters about competitor violations;
6. When to file a lawsuit about an FDA decision;
7. Requesting an expedited review of a petition;
8. Frequent delays in generic approvals;
9. Petitions without proper certification;
10. Lawsuits by agencies, associations and consumers;
11. Strategies for presenting lawsuit causes;
12. Whether referencing Bracco will help or hurt;
13. Vulnerabilities to look for in FDA's decision;
14. Using the Food, Drug and Cosmetic Act (FDCA) in court;
15. Arguing FDA interpretation of Congressional intent;
16. How to use "absurdity" arguments;
17. FDA tendencies to use too much or too little support for claims;
18. Difficulties in persuading the court of arbitrary or capricious decisions;
19. How to change judicial deference to FDA; and
20. What cases to look to for guidance.

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

1. Understand the legal, procedural and practical boundaries of FDA's authority;
2. Develop and implement proactive strategies and tactics to help shape and
   influence FDA policies and procedures; and
3. Identify effective legal strategies when you disagree with an FDA policy or
   regulatory decision.