Professorial Musings on the FDA and the FDC Act

October 13, 2008

Inside Health Policy recently reported on the writings of several professors who opined on courts’ deference to the FDA.  The writings discussed in the Inside Health Policy piece were from the July 2008 Cornell Law Review, which devoted an entire issue to “Symposium: U.S. Food and Drug Regulation in its First Century and Beyond.” 

Regardless of whether you agree with the arguments the authors make, this isn’t a bad resource.  Need a good quote for a brief challenging FDA’s decision-making?  Try n. 29 to Lars Noah’s The Little Agency that Could (Act with Indifference to Constitutional and Statutory Strictures).  Want to argue in favor of deference to FDA?  Pages 943-952 of James T. O’Reilly’s Losing Deference in the FDA's Second Century: Judicial Review, Politics, and a Diminished Legacy of Expertise discusses six important Supreme Court cases involving deference to FDA. 

If you have a products liability case, several articles are worth a skim, including David C. Vladeck’s The FDA and Deference Lost: A Self-Inflicted Wound or the Product of a Wounded Agency? and Carl Tobias’ FDA Regulatory Compliance Reconsidered.

With all due respect to the learned authors, there isn’t an overwhelming amount of useful information for the FDA practitioner.  There are two exceptions, however.  Catherine Struve’s article Greater and Lesser Powers of Tort Reform: The Primary Jurisdiction Doctrine and State-Law Claims Concerning FDA-Approved Products, makes a clever – if untested – argument that the Seventh Amendment right to jury trial limits the effect of the primary jurisdiction doctrine in cases where there is such a right to trial by jury.  In addition, Gary Lawson’s Dirty Dancing – The FDA Stumbles with the Chevron Two-Step, makes the argument that FDA has incorrectly internalized the second step of a court’s analysis under Chevron U.S.A., Inc. v. NRDC, and has given itself license to make a permissible interpretation rather than the “best interpretation possible.” 

In sum, this issue of the Cornell Law Review may be worth skimming the next time you find yourself litigating with FDA or even just a litigating case involving the FDC Act.

By James P. Ellison 

Categories: Miscellaneous