expediting the drug approval process: an analysis of the fda modernization act of 1997


Post on 12-Jan-2017




0 download

Embed Size (px)


  • EXPEDITING THE DRUG APPROVAL PROCESS: AN ANALYSIS OF THE FDA MODERNIZATIONACT OF 1997Author(s): Deborah G. ParverSource: Administrative Law Review, Vol. 51, No. 4 (Fall 1999), pp. 1249-1266Published by: American Bar AssociationStable URL: http://www.jstor.org/stable/40710059 .Accessed: 11/06/2014 01:22

    Your use of the JSTOR archive indicates your acceptance of the Terms & Conditions of Use, available at .http://www.jstor.org/page/info/about/policies/terms.jsp

    .JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range ofcontent in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new formsof scholarship. For more information about JSTOR, please contact support@jstor.org.


    American Bar Association is collaborating with JSTOR to digitize, preserve and extend access toAdministrative Law Review.


    This content downloaded from on Wed, 11 Jun 2014 01:22:10 AMAll use subject to JSTOR Terms and Conditions




    ACT OF 1997

    Deborah G. Parver*

    Table of Contents

    Introduction 1249 I. Background 1252 II. Provisions of FDAMA that Expedite the Drug Approval Proc-

    ess 1258 A. The Reinstatement of PDUFA 1258 B. Expediting Study and Approval of Fast Track Drugs 1 26 1 C. International Harmonization 1263

    III. Potential Public Health Consequences Related to Expedited Drug Review 1264

    Conclusion 1266


    Since the 1970s, the Food and Drug Administration (FDA) has been highly criticized for the length of time needed to approve new and benefi- cial drugs.1 The FDA is often chastised for its overly bureaucratic drug ap-

    * J.D. Candidate, 2000, Washington College of Law, American University; B.A., University of Michigan, 1996. Articles Editor, Administrative Law Review, 1999-2000. The author would like to thank her family and friends for their constant encouragement and support.

    1. See Michael D. Green, Safety as an Element of Pharmaceutical Quality: The Re- spective Roles of Regulation and Tort Law, 42 St. LOUIS U. L.J. 163, 164 (1998) (noting that due to "contemporary criticism" of "overcautious" drug approval process, current re- form proposals focus on acceleration of new drug approval).


    This content downloaded from on Wed, 11 Jun 2014 01:22:10 AMAll use subject to JSTOR Terms and Conditions



    provai process,2 and for causing the United States to lag behind other countries that have expeditiously approved and marketed new therapies.3 Although concern has been voiced for years regarding the drug approval process, Congress did not prioritize comprehensive FDA reform until after the congressional elections of 1994.4

    After three years of debate, Congress passed the FDA Modernization Act of 1997 (FDAMA),5 which instituted major reforms to the Federal Food, Drug, and Cosmetic Act of 1938 (Act of 1938).

    6 Through FDAMA,

    Congress emphasized that the FDA's mission is not only to prevent the distribution of unsafe products, but also to review and approve new drugs in a timely, manner.

    7 Accordingly, Congress set forth numerous provisions

    2. See S. Rep. No. 105-43, at 6 (1997) (stating that FDA's requirements for clinical testing and its review of new products have grown time-consuming, complex, and costly); see also Doug Bandow, Deregulation: The FDA Can Be Hazardous to Your Health, Fortune, Nov. 1996, at 56 (concluding that American drug manufacturers could discover and market new medical treatments if federal government eased its "stultifying regulation" by removing its "roadblocks" to development, testing, and marketing of new drugs).

    3. See Richard A. Merrill, The Architecture of Government Regulation of Medical Products, 82 Va. L. Rev. 1753, 1754 (1996) (finding that unfavorable comparisons in terms of access to new drugs are often drawn between United States and its major trading partners such as Northern Europe, Canada, and Japan). This delay in drug approval is commonly referred to as the "drug lag."

    4. See Margaret Gilhooley, The Administrative Conference and the Progress of Food and Drug Reform, 30 Ariz. St. L.J. 129, 133 (1998) (stating that legislative and executive branches focused on regulation without undue hardship to FDA). "Every administration in the past 20 years has recognized the need for modernizing the FDA's product approval sys- tem to bring into better balance the need to facilitate the development, testing, and timely approval of safe and effective products that benefit the public." S. Rep. No. 105-43, at 10 (1997).

    5. Pub. L. No. 105-115, 111 Stat. 2296 (1997) (to be codified at 21 U.S.C. 310). FDAMA has been described as '"the most important change in drug regulation in twenty years.'" Charles Marwick, Implementing the FDA Modernization Act, 279 JAMA 815 (1998) (quoting Sharon Smith Houston, Deputy Commissioner for External Affairs of FDA).

    6. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (coditied as amended at 21 U.S.C. 301 (1994)).

    /. ee Larry k. mot & uaniei k. waiamann, tooa ana urug Aaministranon Moa- ernization Act of 1997: Medical Device Provisions, 53 FOOD & DRUG L.J. 267 (1998) (de- tailing history of FDA's regulation of medical devices). In 1989, the Secretary of Health and Human Services chartered the Advisory Committee on the FDA to examine the mission, responsibilities, and structure of the FDA. See S. Rep. No. 105-43, at 8 (1997). The Com- mittee found that:

    [T]he agency should be guided by the principle that expeditious approval of useful and safe new products enhances the health of the American people. Approving such products can be as important as preventing the marketing of harmful or ineffective products. This is especially true for people with life-threatening illnesses and for dis- eases for which alternative therapies have not been approved.

    This content downloaded from on Wed, 11 Jun 2014 01:22:10 AMAll use subject to JSTOR Terms and Conditions


  • 1 999] FDA MODERNIZATION ACT 1 25 1

    in FDAMA that will expedite the drug approval process considerably, such as: reinstating the Prescription Drug User Fee Act of 1992 (PDUFA),8 fa- cilitating the accelerated approval of drugs for serious or life-threatening conditions,9 and promoting the FDA's cooperation with other countries to harmonize regulatory requirements.10

    Despite Congress's apparent interest in expediting the drug approval process, FDAMA is indicative of Congress's reluctance to strip the FDA of its monopoly over prescription drug approvals.11 For instance, although FDAMA expressly allows the FDA to contract out to accredited third par- ties to review and approve applications for low to moderate risk medical devices,12 FDAMA does not contain any provisions that expressly provide for third party review of new drug applications.13 Utilizing outside experts to review new drug applications may contribute significantly to expediting the approval process, but the FDA is highly unlikely to allow third parties to review drugs for approval.14

    This Comment analyzes provisions of FDAMA that focus on expedited drug approval, and discusses the tension between the public health interest in the production and approval of safe and efficacious drugs and the need for an accelerated drug approval process. Part I examines the background of the modern drug approval process prior to the passage of FDAMA, in-

    Id. 8. Pub. L. No. 102-571, 106 Stat. 4491 (1992) (codified as amended at 21 U.S.C.

    379g-h (1994 & Supp. Ill 1997)). 9. See 1 12, 1 1 1 Stat. at 2309-12.

    10. See 410, 1 1 1 Stat. at 2372-73. 1 1 . ee Michael I. Krauss, Breaking the FDA s Drug Approval Monopoly: Implications

    for Tort Law and Consumer Welfare (visited Sept. 23, 1998) [hereinafter Krauss].

    12. See 210, 111 Stat. 2342-45 (1997) (to be codified at 21 U.S.C. 360(m)). The FDA has classified medical devices into one of three regulatory classes. Joel Hoffman, The Food and Drug Administration's Administrative Procedures, in FOOD AND DRUG Law 18 (Richard M. Cooper ed., 1991). Class I devices are generally not used to support or sustain life, and do not pose a potentially unreasonable risk of injury or illness. Id. When general controls, "such as the misbranding and adulteration provisions, are insufficient in regards to a device, and a pre-marketing approval requirement would be burdensome," those devices are classified as Class II devices and performance standards are set. Id. Finally, Class III devices require pre-market clearance, they are used to support or sustain life, and they may present a "potential unreasonable risk that cannot adequately be regulated by a performance standard." Id.

    13. See 415, 111 Stat. at 2377-78 (allowing outside contractors to review applications but not requiring FDA to use outside experts or to issue any guidance documents or regula- tions to mandate this provision).

    14. See generally 143 Cong. Rec. S 12,24 1-42 (exemplifying Congress's difficulty in codifying third-party approval of low-risk medical devices because of public health con- cerns).

    This content downloaded from on Wed, 11 Jun 2014 01:22:10