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  1. Generic Drug User Fee Amendments

FY2016 Regulatory Science Report: Postmarket: Data Analysis for Generic Drugs

This section contains only new information from FY2016. For background scientific information and outcomes from previous years on this research topic, please refer to the FY15 Regulatory Science Research Report on Postmarket: Data Analysis for Generic Drugs.

ORS staff facilitating research in this area

  • Sarah Dutcher, Xinyuan Zhang, Liang Zhao, Meng Hu, Xia Pu, Zhong Wang, Saeid Raofi

Projects and Collaborators

  • Assessing clinical equivalence for generic drugs approved by innovative methods
    • Site PI: Aaron Kesselheim
    • Grant #: U01FD004856
  • Does variation in the physical characteristics of generic drugs affect patients’ experiences? Surveys of pharmacists and patients
    • Site PI: Aaron Kesselheim
    • Contract #: HHSF223201310232C
  • Postmarketing surveillance of generic drug usage and substitution patterns
    • Site PI: Ilene Harris
    • Grant #: U01FD004855
  • Assessing the post-marketing safety of authorized generic drug products
    • Site PI: Joshua Gagne
    • Grant #: U01FD005279
  • Post-market authorized generic evaluation (PAGE)
    • Site PI: Richard Hansen
    • Grant #: U01FD005272
  • Effect of therapeutic class on generic drug substitutions
    • Site PI: Jodi Segal
    • Grant #: U01FD005267
  • Novel approaches for confounding control in observational studies of generic drugs
    • Site PI: Rishi Desai
    • Grant #: U01FD005555
  • Structural nested models for assessing the safety and effectiveness of generic drugs
    • Site PI: Ravi Varadhan
    • Grant #: U01FD005556
  • Comparative surveillance of generic drugs by machine learning
    • Site PI: Peggy Peissig
    • Contract #: HHSF223201510112C

Publications and Presentations

  • Kesselheim AS, Gagne JJ, Eddings W, Franklin JM, Ross KM, Fulchino LA, Campbell EG. Prevalence and Predictors of Generic Drug Skepticism among Physicians: Results of a National Survey. JAMA Intern Med;176(6):845-7 (Jun 1, 2016)
  • Gagne JJ, Polinski JM, Jiang W, Dutcher SK, Xie J, Lii J, Fulchino LA, Kesselheim AS. Switch-backs associated with generic drugs approved using product-specific determinations of therapeutic equivalence. Pharmacoepidemiol Drug Saf. (Apr 22, 2016)
  • Kesselheim AS, Gagne JJ, Franklin JM, Eddings W, Fulchino LA, Avorn J, Campbell EG. Variations in Patients' Perceptions and Use of Generic Drugs: Results of a National Survey. J Gen Intern Med;31(6):609-14 (Jun 2016)
  • Romanelli RJ, Nimbal V, Segal JB. Provider-level variation and determinants of outpatient generic prescribing in a mixed-payer healthcare system. 22nd Annual Health Care Systems Research Network Conference, Atlanta GA (April 13-16, 2016)
  • Nimbal V, Segal JB, Romanelli RJ. Estimating generic drug utilization with electronic health records from a mixed-payer ambulatory healthcare delivery system. 22nd Annual Health Care Systems Research Network Conference, Atlanta GA (April 13-16, 2016)
  • Daubresse M, Lee CY, Moechtar M, Dutcher S, Romanelli R, Segal JB. Predictors of generic thyroid hormone utilization among the commercially insured. International Society for Pharmacoepidemiology Mid-Year Meeting, Baltimore MD (April 10-12, 2016)
  • Kesselheim AS, Eddings W, Raj T, Campbell EG, Franklin JM, Ross KM, Fulchino LA, Avorn J, Gagne JJ. Physicians’ Trust in the FDA’s use of product-specific pathways for generic drug approval. PLoS One;11(10):e0163339 (2016)
  • Segal JB, Daubresse M, Onasanya O, Dutcher S, Jiang W, Romanelli R. Determinants of generic drug substitution in the United States. Abstract #612. International Conference on Pharmacoepidemiology, Dublin Ireland (August 25-28, 2015)
  • Iyer G, Marimuthi S, Segal JB, Singh S. Identification of generic drugs in the FDA adverse event reporting system. Abstract #696. International Conference on Pharmacoepidemiology, Dublin Ireland (August 25-28, 2015)
  • Marimuthu S, Iyer G, Segal JB, Singh S. Patient Relevant Outcomes Associated with Generic Drugs in FDA's Adverse Event Reporting System. Abstract #723. International Conference on Pharmacoepidemiology, Dublin Ireland (August 25-28, 2015)
  • Hansen RA, Qian J, Berg R, Linneman J, Seoane-Vazquez E, Dutcher S, Raofi S, Peissig P. Comparison of generic-to-brand switchback patterns for authorized generic vs. independent generic drugs. Abstract #610. International Conference on Pharmacoepidemiology, Dublin Ireland (August 25-28, 2015)
  • Hansen RA, Qian J, Berg R, Linneman J, Seoane-Vazquez E, Dutcher S, Raofi S, Peissig P. Comparison of outcomes following a switch from a brand to an authorized vs independent generic drug. Abstract #1036. International Conference on Pharmacoepidemiology, Dublin Ireland (August 25-28, 2015)
  • Lee CY, Chen X, Romanelli RJ, Segal JB. Forces influencing generic drug development in the United States: a narrative review. J Pharm Policy Pract;9:26 (2016)
  • Nimbal V, Segal JB, Romanelli RJ. Estimating Generic Drug Use with Electronic Health Records Data from a Health Care Delivery System: Implications for Quality Improvement and Research. J Manag Care Spec Pharm;22(10):1143-7 (2016)

Outcomes

  • Research projects in progress

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