CPR Comments on FDA Generics Rule

Sidney A. Shapiro holds the Fletcher Chair in Administrative Law at the Wake Forest University School of Law and is the Associate Dean for Research and Development. He is a member of the board of directors of the Center for Progressive Reform.

Professor Shapiro has taught and written in the areas of Administrative Law, Regulatory Law and Policy, Environmental Policy, and Occupational Safety and Health Law for 25 years.

While in academia, Shapiro has served as a consultant to the Administrative Conference of the United States (ACUS), the Office of Technology Assessment of the U.S. Congress (OTA), and the U.S. Occupational Safety and Health Administration (OSHA). With Professor Thomas O. McGarity, Professor Shapiro designed and helped initiate a rulemaking prioritization process for OSHA rulemaking during the early 1990s. As a consultant to OTA, Professor Shapiro assessed various regulatory tools or options that agencies can use to implement regulation. As a consultant to ACUS, Professor Shapiro studied the efficacy of the regulatory process at EPA (noise control), OSHA, and the Food and Drug Administration (FDA).

Professor Shapiro began his legal career as a trial attorney in the Bureau of Competition of the Federal Trade Commission and later worked as the Deputy Legal Counsel, Secretary's Review Panel on New Drug Regulation at the Department of Health, Education and Welfare.

Professor Shapiro has published widely in the areas of regulatory law and policy. He co-authored The People’s Agents and the Battle to Protect the American Public: Special Interests, Government, and Threats to Health, Safety, and the Environment, with CPR President, Rena Steinzor. This book reviewed years of government actions and inactions leading to the decline of the five protector agencies. His book, Risk Regulation at Risk: Restoring a Pragmatic Approach, analyzes health and safety and environmental protection laws and policy, and argues for a pragmatic approach to policy in these areas instead of using economic analysis to set regulatory goals. Workers at Risk, co-authored with Thomas O. McGarity, describes rulemaking, implementation and enforcement in the Occupational Safety and Health Administration from its inception in 1970 through 1990. The book analyzes OSHA's strengths and weaknesses and makes many recommendations for improving standard-setting and enforcement. Shapiro's casebook, Administrative Law and Procedure: A Problem Approach, co-authored with William Funk and Russell Weaver, is used in administrative law courses at law schools throughout the country. His casebook, Regulatory Policy and Law, is the first of its kind, and is used to train lawyers to evaluate and advocate for public policy.

Professor Shapiro has published dozens of articles on regulatory policy, health and safety laws, environmental law and administrative law in prominent law reviews, such as the Harvard Law Review, Duke Law Journal and the Wake Forest Law Review, as well as in specialty journals, such as the Administrative Law Review and the Ecology Law Quarterly.

Professor Shapiro has been an active participant in efforts to improve health, safety and environmental quality in the United States. He has testified before congressional committees on administrative law and occupational safety and health issues. He has worked with various public interest groups in advisory and support capacities, including Public Citizen Global Trade Watch, Public Citizen Congress Watch, and OMB Watch. 

Sidney Shapiro
Wake Forest University School of Law
Winston-Salem, NC
336.758.7320
email
website

Thomas O. McGarity holds the Joe R. and Teresa Lozano Long Endowed Chair in Administrative Law at the University of Texas in Austin. He is a member of the board of directors of the Center for Progressive Reform, and a past president of the organization.

Professor McGarity has taught and written in the areas of Administrative Law, Environmental Law, Occupational Safety and Health Law, Food Safety Law, Science and the Law, and Torts for twenty-five years.

While in academia, McGarity has served as a consultant and/or advisor to the Administrative Conference of the United States, the Office of Technology Assessment of the U.S. Congress (OTA), the U.S. Environmental Protection Agency, the U.S. Occupational Safety and Health Administration (OSHA), the Texas Department of Agriculture, and the Texas Natural Resource Conservation Commission. With Professor Sidney A. Shapiro, Professor McGarity designed and helped initiate a rulemaking prioritization process for OSHA rulemaking during the early 1990s. As a consultant to OTA, Professor McGarity helped write the "Regulatory Tools" report that agencies have frequently cited in designing regulatory programs. As a consultant to the Texas Department of Agriculture, McGarity was a primary draftsperson of that agency's first farmworker protection regulations in the late 1980s. During the mid-1990s, he was also actively involved in the drafting of and negotiations surrounding the federal Food Quality Protection Act.

Professor McGarity began his legal career in the Office of General Counsel of the Environmental Protection Agency. In the private sector, Professor McGarity has served as counsel or consultant in various legal and administrative proceedings to the Natural Resources Defense Council, Public Citizen, the Sierra Club, the American Lung Association, the National Audubon Society, Texas Rural Legal Aid, California Rural Legal Aid, and many local organizations, including, for example, The Bear Creek Citizens for the Best Environment Ever. McGarity has also served on many advisory committees for such entities as the U.S. Environmental Protection Agency, the Office of Technology Assessment, and the National Academy of Sciences.

Professor McGarity has published widely in the areas of regulatory law and policy. His book Reinventing Rationality analyzes the advantages and disadvantages of cost-benefit analysis in regulatory decision-making and describes the use of such regulatory impact assessments by federal agencies and the Office of Management and Budget during the Reagan Administration. Workers at Risk, co-authored with Sidney A. Shapiro, describes rulemaking, implementation and enforcement in the Occupational Safety and Health Administration from its inception in 1970 through 1990. The book then analyzes OSHA's strengths and weaknesses and makes many recommendations for improving standard-setting and enforcement. McGarity's casebook, The Law of Environmental Protection, co-authored with John Bonine, has been used in introductory Environmental Law courses at law schools throughout the country. His relatively recent books include The Preemption War: When Federal Bureaucracies Trump Local Juries, Yale University Press 2008, and Bending Science: How Special Interest Corrupt Public Health Research, Harvard University Press 2008, co-authored with fellow CPR Member Scholar Wendy Wagner.

Professor McGarity has published dozens of articles on environmental law, administrative law, and toxic torts in prominent law reviews, such as the Harvard Law Review, Chicago Law Review, Pennsylvania Law Review and Law & Contemporary Problems, as well as in specialty journals, such as the Administrative Law Review, the Harvard Environmental Law Review, Risk, and the Kansas Journal of Law & Public Policy, and consumer magazines like the American Prospect and the Hastings Center Report. McGarity has written on federal regulation of biotechnology since the advent of the commercialization of recombinant DNA techniques, and his article in the Duke Law Journal on the "ossification" of the federal rulemaking process, which elaborates on the dangers of encumbering the process of promulgating health and environmental rules with burdensome analytical requirements and review procedures, is frequently cited in the recurrent "regulatory reform" debates.

Professor McGarity has been an active participant in efforts to improve health, safety and environmental quality in the United States. He has testified before many congressional committees on environmental, administrative law, preemption of state tort laws in cases involving medical devices, and occupational safety and health issues. During the first session of the 104th Congress (the "Gingrich" Congress), Professor McGarity was frequently the lone representative of the view that federal regulation had an important role to play in protecting public health and the environment on panels testifying before House and Senate Committee considering "regulatory reform" legislation. Professor McGarity has also participated in path-breaking legal challenges to government inaction like Environmental Defense Fund v. Blum (a challenge to EPA's decision to allow further use of the carcinogenic pesticide mirex through emergency use exemptions) and Les v. Reilly (a challenge to EPA's failure to establish protective tolerances for eight carcinogenic pesticides). As a result of the latter litigation, the pesticide industry was forced to accept the greater protections afforded children in the Food Quality Protection Act of 1996. 

Thomas McGarity
The University of Texas School of Law
Austin, TX
512.232.1384
email
website

James Goodwin, J.D., M.P.P., is a Senior Policy Analyst with the Center for Progressive Reform. He joined CPR in May of 2008. Prior to joining CPR, Mr. Goodwin worked as a legal intern for the Environmental Law Institute and EcoLogix Group, Inc. He is a published author with articles on human rights and environmental law and policy appearing in the Michigan Journal of Public Affairs and the New England Law Review (co-author with Armin Rosencranz).

Mr. Goodwin graduated magna cum laude from Kalamazoo College, where he received a B.A. with honors in Political Science. He received his law degree (with a certificate in environmental law) from the University of Maryland School of Law, where he graduated magna cum laude, and his master’s degree in public policy (concentration in environmental policy) from the University of Maryland School of Public Policy, where he graduated as class valedictorian. While at the University of Maryland School of Law, Mr. Goodwin was a member of the Moot Court team. He is a member of Order of the Coif and Phi Beta Kappa. 

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