Stephen Ceccoli

Recent Research

  1. FDA: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities
    Author: U.S. General Accounting Office
    GAO 02-958 October 2002.
  2. Pharmaceutical Policy Change And The Safety Of New Drugs
    Author: Mary K. Olson, Yale University
    Journal of Law and Economics, vol. XLV (October 2002), pp. 615-642

    Policy reforms in the Food and Drug Administration (FDA) have led to substantial increases in the speed of new-drug review. While data show that FDA review times for new drugs have fallen as much as 50 percent, other data show that several new drugs have been withdrawn from the market for safety reasons. This flurry of new-drug withdrawals raises a question. Have increases in the speed of new-drug review had an adverse effect on new-drug safety? This analysis uses adverse drug reaction (ADR) data from the FDA′s Spontaneous Reporting System to examine this question. Specifically, ADR counts for newly approved drugs are estimated as a function of drug characteristics, patient characteristics, and regulatory factors (such as the speed of new-drug review) using negative binomial regression analysis. The primary result is that reductions in new-drug review times are associated with increases in both ADRs requiring hospitalization and ADRs resulting in death.
  3. FDA Oversight of Direct-to-Consumer Advertising Has Limitations
    Author: U.S. General Accounting Office
    GAO 03-177 October 2002.
  4. The U.S. Drug Approval Process: A Primer
    Author: Blanchard Randall IV
    Congressional Research Service, June 1, 2001
  5. Safety of Newly Approved Drugs: Implications for Prescribing
    Authors: R. Temple and M. Himmel
    JAMA, May 1, 2002 Vol. 287(17):2273-5.
  6. Pharmaceutical Research and Manufacturers Association
    Pharmaceutical Industry Profile, 2003
  7. National Center for Health Statistics
  8. National Health Information Center
    (NIHC is a health information referral service that provides health resources for consumers and health professionals.)
  9. Useful Pharmacy-related Journals
    (c/o Dalhousie University, Halifax, Nova Scotia, Canada)