What Should Congress Do about Generic or Follow-On Biologic Drugs?
John E. Calfee , Scott Gottlieb, Henry G. Grabowski
June 11, 2007
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The 1984 Hatch-Waxman Act created a streamlined path for generic drugs to reach the market after pioneer drug patents expire. The result has been the most vigorous and competitive generic drug market in the world, but the Hatch-Waxman Act does not apply to most biologics. Isolated from a variety of natural sources (human, animal, or microorganism), biologics are produced by biotechnology methods or other cutting-edge technologies, and unlike common small-molecule pharmaceuticals, these new drugs generally have a high molecular complexity which may be sensitive to changes in the manufacturing process. Newer biotech biologics are responsible for revolutionizing the treatment of cancer and rheumatoid arthritis among many other diseases.

Because follow-on biologics--drugs that follow the original pioneering ones--are grown through biological processes rather than manufactured in the traditional sense, they pose special difficulties for approval and safe use. Panelists at this conference will discuss regulation (including in Europe, which already has a follow-on biologic pathway), manufacturing, economics, and intellectual property.

About the Author

 

John E.
Calfee

  • Economist John E. Calfee (1941-2011) studied the pharmaceutical industry and the Food and Drug Administration (FDA), along with the economics of tobacco, tort liability, and patents. He previously worked at the Federal Trade Commission's Bureau of Economics. He had also taught marketing and consumer behavior at the business schools of the University of Maryland at College Park and Boston University. While Mr. Calfee's writings are mostly on pharmaceutical markets and FDA regulation, his academic articles and opinion pieces covered a variety of topics, from patent law and tort liability to advertising and consumer information. His books include Prices, Markets, and the Pharmaceutical Revolution (AEI Press, 2000) and Biotechnology and the Patent System (AEI Press, 2007). Mr. Calfee wrote regularly for AEI's Health Policy Outlook series. He testified before Congress and federal agencies on various topics, including alcohol advertising; biodefense vaccine research; international drug prices; and FDA oversight of drug safety.

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Scott
Gottlieb
  • Scott Gottlieb, M.D., a practicing physician, has served in various capacities at the Food and Drug Administration, including senior adviser for medical technology; director of medical policy development; and, most recently, deputy commissioner for medical and scientific affairs. Dr. Gottlieb has also served as a senior policy adviser at the Centers for Medicare & Medicaid Services. 

     

  • Phone: 202-862-5885
    Email: scott.gottlieb@aei.org

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    Name: Catherine Griffin
    Phone: 2028625920
    Email: catherine.griffin@aei.org
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Henry G.
Grabowski
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