Academic

Hawley on the Food & Drug Administration Amendments Act & Delegation

By Lawrence Solum

Kristen Hawley (University of Houston Law Center) has posted Of Public Interest: Congress' Delegation to the Reagan-Udall Foundation (Houston Law Review, Forthcoming) on SSRN. Here is the abstract:

In the wake of several high profile drug safety cases, including the Vioxx controversy and a subsequent government investigation, the FDA acknowledged a need for greater oversight of postmarket drug safety. In September 2007, Congress passed the Food and Drug Administration Amendments Act ("FDAAA"), providing tangible avenues for that oversight.

The act has two significant features. First, in an effort to obtain better postmarket drug surveillance, it creates a national health database called the Sentinel System. Second, it establishes a private nonprofit entity called the Reagan-Udall Foundation ("the Foundation'') to help "advance FDA's mission." If the FDAAA is construed narrowly, the Foundation's statutory mandate deserves support. If, however, the FDA delegates the Sentinel System's operation to the Foundation, the collaboration faces significant procedural, philosophical, and ethical questions. For example, would this delegation treat the Foundation as a private entity or sub-agency? What impact does that designation have on the Foundation's due process and accountability obligations? How will the Foundation appease its funding partners in the pharmaceutical industry, while maintaining whatever ethical obligations it has to the American public?

Part I examines the FDAAA's vision of the Reagan-Udall Foundation and the confusion surrounding the Sentinel System's administration. Part II explains benefits of the Reagan-Udall Foundation as envisioned by the FDAAA and proves the sufficiency of existing procedural safeguards. Part III tackles the messy contours of the FDA's proposed delegation of the Sentinel System to the Foundation, including problems with the nondelegation doctrine, due process, and accountability. Part IV briefly explores the value of public-private partnerships in the healthcare context to illustrate signature burdens and benefits of these collaborations. Finally, Part V offers some thoughts on protecting the Foundation's integrity, guiding its relationship to the FDA, and preserving its obligation to American citizens. Once shielded from the pressures of politics and funding, the Reagan-Udall Foundation can achieve its goal: protecting the public's health.

Full post as published by Legal Theory Blog on April 08, 2009 (boomark / email).