Proceed with Caution: The Implications of the OMB Peer Review Guidelines on Precautionary Legislation

Washington University Law Review Volume 84 Issue 2 January 2006 Proceed with Caution: The Implications of the OMB Peer Review Guidelines on Precautionary Legislation Maureen Mahon Washington University School of Law Follow this and additional works at: https://openscholarship.wustl.edu/law_lawreview Part of the Administrative Law Commons, and the Legislation Commons Recommended Citation Maureen Mahon, Proceed with Caution: The Implications of the OMB Peer Review Guidelines on Precautionary Legislation, 84 WASH. U. L. REV. 461 (2006). Available at: https://openscholarship.wustl.edu/law_lawreview/vol84/iss2/5 This Note is brought to you for free and open access by the Law School at Washington University Open Scholarship. It has been accepted for inclusion in Washington University Law Review by an authorized administrator of Washington University Open Scholarship. For more information, please contact . PROCEED WITH CAUTION: THE IMPLICATIONS OF THE OMB PEER REVIEW GUIDELINES ON PRECAUTIONARY LEGISLATION INTRODUCTION Imagine this situation: A nervous young father is eager to help his fluridden daughter feel better. To alleviate her pain, as any parent would do, he opens the medicine cabinet for some aspirin, checks the warning and dosage label, and administers the medication to his child. She later develops Reye’s syndrome—a rare but debilitating disease that can be fatal. Unbeknownst to this parent, studies had revealed a higher incidence of Reye’s syndrome in children who had been given aspirin to ease pain caused by certain viral infections. No warning label existed because the aspirin industry was fighting government efforts to include a warning label despite four studies linking Reye’s syndrome to aspirin use. 1 The industry successfully persuaded the government to undertake further studies, but in December 1985, the Federal Drug Administration (FDA) finally issued a proposal mandating labels cautioning potential users about the risks of Reye’s. 2 Since 1986, labels have been included on all aspirin bottles warning that administering aspirin to children with colds, flu, or chicken pox, could lead to an increased chance of developing Reye’s syndrome. 3 Had the government been authorized to act in a timelier manner, perhaps more instances of this illness could have been avoided. 4 Citizens expect their government to promulgate rules and regulations that are based on accurate information. 5 Agencies are generally considered 1. See Joseph Gastwirth, The Need for Careful Evaluation of Epidemiological Evidence in Product Liability Cases: A Reexamination of Wells v. Ortho and Key Pharmaceuticals, 2 LAW PROB. & RISK 151, 156 (2003). 2. Proposed Labeling for Oral Aspirin-Containing Drug Products, 50 Fed. Reg. 51,400 (Dec. 17, 1985). 3. Labeling for Oral and Rectal Over-the-Counter Aspirin and Aspirin-Containing Drug Products, 51 Fed Reg. 8180 (Mar. 7, 1986). For a detailed factual account of the history surrounding the efforts to include warning labels, see American Home Products Corp. v. Johnson & Johnson, 672 F. Supp. 135, 137–41 (S.D.N.Y. 1987). 4. See Letter from Joseph L. Gastwirth, Professor of Statistics, George Washington University, to Jack B. Weinstein, Senior District Judge, United States District Court for the Eastern District of New York (Mar. 13, 2001) (concluding that some 100 cases of Reye’s syndrome might have been prevented had the FDA issued warnings in 1982). 5. Donald T. Hornstein, Accounting for Science: The Independence of Public Research in the New, Subterranean Administrative Law, LAW & CONTEMP. PROBS., Autumn 2003, at 246 (“Science is an enormously important public resource in a free society, and there are, accordingly, enormous benefits in maintaining public confidence in its underlying integrity as a process.”). 461 Washington University Open Scholarship p461 Mahon book pages.doc11/20/2006 462 WASHINGTON UNIVERSITY LAW REVIEW [VOL. 84:461 to have expertise in their particular field of regulation, and are trusted to use this expertise to make policy decisions in the best interest of society. Agencies rely on scientific studies to guide them in making these policy choices, but this guidance is rarely conclusive as even the most advanced scientific research will leave some questions unanswered. 6 For instance, when experiments are conducted to determine the toxicity of particular chemicals, the data cannot establish a “safe” level of exposure. 7 Instead, it is the agency officials who must consider competing policy concerns in quantifying the risk at an appropriate level. 8 Moreover, it is very difficult, if not unethical, to conduct research with respect to many of the greatest public health and environmental concerns. 9 As a result, agencies are often forced to make decisions based on scientific research riddled with uncertainty. 10 Concrete assurances that the benefits of a given regulation will outweigh its risks seem the best way to ensure the administration of true “justice.” 11 However, this goal is difficult to reconcile with the field of science where research is hampered with uncertainty. 12 Such uncertainty should not bar all regulations, but most would agree that some restraints 6. See Wendy E. Wagner, The “Bad Science” Fiction: Reclaiming the Debate over the Role of Science in Public Health and Environmental Regulation, LAW & CONTEMP. PROBS., Autumn 2003, at 64 (“Science teases policymakers with the prospect of providing definitive guidance for regulatory decisionmaking. But in reality, the information that most scientific research provides to health and environmental regulation is incomplete and inconclusive . . . .”). 7. See Wendy Wagner, The Science Charade in Toxic Risk Regulation, 95 COLUM. L. REV. 1613, 1622 (1995) (explaining that while scientific experiments can establish the effects of certain substances on controlled subjects in controlled circumstances, the quantitative risk to humans can not be conclusively resolved through science, leaving those gaps to be filled by policy choices). 8. Id. at 1622 n.28 (defining “policy” to include “the reasoned weighing of various economic and social outcomes . . . [and] the conscious or subconscious biases, guesses, and intuition of decisionmakers.”). 9. Id. at 1621 (identifying the ethical limitations of toxic testing that force scientists to extrapolate from animal studies rather than conduct experiments on human subjects). 10. See Wagner, supra note 7, at 1619–22 (describing the limits of science in the context of risk assessment and explaining that where science is unable to provide a conclusive answer, policy considerations must fill in these gaps). 11. See David Kriebel et al., The Precautionary Principle in Environmental Science, 109 ENVTL. HEALTH PERSP. 873, 875 (2001) (“Although there are some situations in which risks clearly exceed benefits no matter whose values are being considered, there is usually a large gray area in which science alone cannot (and should no (...truncated)