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40 Regulation 2 (2017-2018)
How the FDA Virtually Destroyed an Entire Sector of Biotechnology

handle is hein.journals/rcatorbg40 and id is 212 raw text is: 2 / Regulation / WINTER 2017-2018 Regulation,'A EDITOR PETER VAN DOREN MANAGING EDITOR THOMAS A. FIREY DESIGN AND LAYOUT DAVID HERBICK DESIGN CIRCULATION MANAGER ALAN PETERSON CONTRIBUTING EDITORS SAM BATKINS, IKE BRANNON, ART CARDEN, THOMAs A. HEMPHILL, DAVID R. HENDERSON, DWIGHT R. LEE, GEORGE LEEF, PIERRE LEMIEUX, PHIL R. MURRAY EDITORIAL ADVISORY BOARD CHRISTOPHER C. DEMUTH Distinguished Fellow, Hudson Institute SUSAN E. DUDLEY Research Professor and Director of the Regulatory Studies Center George Washington University WILLIAM A. FISCHEL Professor ofEconomics, Dartmouth College H.E. FRECH III Professor ofEconomics, University of California, Santa Barbara ROBERT W. HAHN Professor and Director ofEconomics, Smith School, Oxford University Scorr E. HARRINGTON Alan B. Miller Professor Wharton School, University ofPennsylvania JAMES J. HECKMAN Henry Schultz Distinguished Service Professor ofEconomics, University of Chicago ANDREW N. KLEIT MICASU Faculty Fellow, Pennsylvania State University MICHAEL C. MUNGER Professor ofPolitical Science, Duke University ROBERT H. NELSON Professor of Public Affairs. University of Maryland SAM PELTZMAN Ralph and Dorothy Keller Dtinguished Service Professor Emeritus ofEconomics, University ofChicago GEORGE L. PRIEST John M. Olin Professor ofLaw and Economics, Yale Law School PAUL H. RUBIN Professor ofEconomics and Law, Emory University JANE S. SHAW Board Member John William Pope Center for Higher Education Policy RICHARD L. STROUP Professor Emeritus ofEconomics Montana State University W. KIP ViscusI University Dstinguished Professor ofLaw Economics, and Management Vanderbilt University RICHARD WILSON Mallinckrodt Professor ofPhysics, Harvard University CLIFFORD WINSTON Senior Fellow in Economic Studies, Brookings Institution BENJAMIN ZYCHER John G. Searle Chair American Enterprise Institute PUBLISHER PETER GOETTLER President and CEO, Cato Institute REGULATION was first published inJuly 1977 because the extension of regulation is piecemeal, the sources and targets diverse, the language complex and often opaque, and the volume overwhelming. REGULATION is devoted to analyzing the implications of government regulatory policy and its effects on our public and private endeavors. How the FDA Virtually Destroyed an Entire Sector of Biotechnology a BYJOHNJ. COHRSSEN AND HENRY I. MILLER ogs bark, cows moo, and regulators regulate, former U.S. Food and Drug Administration commissioner Frank Young once quipped to explain regulatory agen- cies' expansionist tendencies. There may be no better example than the FDA's oversight of genetically engineered animals. This oversight misguidedly extends a regulatory regime designed specifically for the approval of new animal drugs to the regulation of the animals themselves. This sophistic and wrong-headed approach has resulted in regulatory paralysis and the near annihila- tion of an entire once-promising genetic engineering sector in which the United States was poised to be preeminent. In 2009 the FDA aggressively seized control of the regulation of genetically engineered animals. That year the agency published a guidance that required all genetically engineered animals, from whales to mosquitoes, to be regulated by its Center for Veterinary Medicine. Accord- ing to the guidance the animals would be regulated like new animal drugs such as antibiotics, pain relievers, or flea medi- cines. The rationale was that intentionally altered genomic DNA that is in a geneti- cally engineered animal and is intended to affect the animal's structure or function meets the definition of an animal drug. Until that policy, no one-certainly no members of Congress or officials at other regulatory agencies-had conceived of the FDA claiming oversight of the breed- ing of pets, farm animals, or any other animals. For example, the FDA did not JOHNJ. COHRSSEN is an attorneywho has served in a number of government posts in the executive and legislative branches of the federal government, includ- ing associate director of President George H.W. Bush's Council on Competitiveness and counsel for the House Energy and Commerce Committee. HENRY I. MILLER, aphysician, is the Robert Wesson Fellowin Scientific Philosophy and Public Policy at Stanford University's Hoover Institution. He was the founding director of the Office of Biotechnology at the U.S. Food and Drug Administration. evaluate greyhounds bred by conventional techniques to enhance (DNA-mediated) traits that make them faster runners; cats that are better mousers; or even animals that have been modified with molecular genetic engineering techniques for scien- tific research, which includes hundreds of lines of rodents. Fish story/ Only a couple of animals have been reviewed by the FDA under the guidance, and it is no exaggeration to say that the regulators' performance has been near-catastrophic. The first was the AquAdvantage Atlantic salmon, which reaches maturity 40% faster (and con- sumes 25% less food) than its unmodi- fied cohorts. We've told the story of this fish in these pages before, but it merits repeating. The genetic changes confer no detectable difference in the fish's appear- ance, ultimate size, taste, or nutritional value; it just grows faster, which is a tre- mendous economic advantage to those farming the fish in a closed-water system. Also, because the fish are sterile females and farmed inland, there is negligible pos- sibility of any sort of genetic contami- nation of the wild salmon gene pool or other environmental effects. Long before the FDA issued its guidance in 2009, its officials had told AquaBounty, the fish's creator, to submit a marketing approval application to the FDA, although there was no clear regula- tory rationale or pathway for evaluating it. The agency delayed the application for

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