Essay by Lars Noah
In a recent issue of this journal, Margaret Gilhooley analyzed a pair of important First Amendment challenges to the regulatory activities of the U.S. Food and Drug Administration (FDA). After providing an exhaustive description of this litigation, Professor Gilhooley chastised the courts for their readiness to resolve these cases on a constitutional basis when other grounds might have sufficed. In particular, she suggested that substantive judicial review based on statute would have provided a more appropriate mechanism for supervising the Agency's policy choices. Unfortunately, traditional doctrines of administrative law may not be equal to that task. Although a preference for sidestepping constitutional difficulties should come as no great surprise, ultimately agency officials and judges must squarely face the First Amendment issues presented in these cases.
The recent litigation spearheaded by the Washington Legal Foundation (WLF) against the FDA amply illustrates the shortcomings of a strategy based on the Administrative Procedure Act (APA). WLF challenged the Agency's efforts to limit the dissemination of information by manufacturers of drugs and medical devices. Once a new drug or medical device receives marketing clearance from the FDA, it can be promoted only for the indications set forth in the approved labeling. Physicians, however, remain free to use these therapeutic products for other purposes. In the early 1990s, the FDA became concerned that some manufacturers were indirectly promoting such “off-label” uses, for instance by sponsoring continuing medical education (CME) programs and scientific symposia featuring discussions about such uses of their products and by providing health care professionals with “enduring materials” (namely, textbooks or reprints of published articles) mentioning such uses. In addition to bringing enforcement actions against particular companies, the Agency issued a “draft policy statement” in 1992 to inform the industry that it might regard such activities as unlawful product promotions unless certain steps were taken to ensure editorial independence. Although characterized at the time as a “safe harbor,” these announcements were part of a crackdown on perceived industry excesses rather than an enlightened effort to liberalize existing prohibitions that seemed unduly restrictive.
The simplest answer to Professor Gilhooley's recommended approach is that WLF chose not to bring any APA-based challenges. Even if courts were to abide by the “avoidance canon” more consistently than they have in the past, judges could not decline to address a First Amendment question where the petitioners had decided to frame their lawsuit solely in constitutional terms. Undoubtedly, WLF decided against attacking the agency's policies on all available grounds so that it could create a constitutional test case. In hindsight, this also represented good strategy given the FDA's initial litigating position. When the government filed a motion to dismiss the lawsuit, it interposed various justiciability objections, most significantly that the FDA's decision was not yet ripe for review. When agencies seek to insulate their decisions in this manner, the inclusion of a constitutional challenge may help to tip the balance in favor of judicial review. Finally, after the focus shifted to the relevant provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA), WLF could not have pursued any APA-based claims; it could have assailed the new legislation only on constitutional grounds.
About the Author
Lars Noah. Visiting Professor, University of Texas School of Law; Professor of Law, University of Florida.
Citation
75 Tul. L. Rev. 137 (2000)