Leafy Campus
Huntingdon College: program in Political Science and Public Affairs: FOIA Research Index.
Amy Grant, 'FDA, Freedom of Information Cases.'
From presentation outline.
compiled by Jeremy Lewis, PhD, revised 10 Jun 2004.
Provided for fair academic purposes only.
  • Internet Effect, researchers' page
  • My Professional Writings

  • 1. Case Studies in FDA
    Freedom of Information (FOI) Requests
    Amy N. Grant
    Regulatory Knowledge Manager
    US Regulatory Affairs, Astrazeneca Special Libraries Association (SLA)
    Annual Conference Pharmaceutical & Health Technology Division Los Angeles, CA June 11, 2002

    2. Why Use FOI?
    (Supporting AstraZeneca U.S. Mission)
    •Discovering, developing and delivering innovative pharmaceutical solutions
    •Enriching the lives of patients, families, communities and other stakeholders
    •Creating a challenging and rewarding work environment for everyone

    3. Why Use FOI?  (Continued)
    •Provides a valuable tool to learn from the actions of others
    •Provides perspective to review medical, scientific, investigative, legal, policy, and other issues •Provides access to documents not readily available

    4. Regulatory Affairs Fundamentals
    •Laws •Regulations •Guidances •Interpretation

    5. Freedom of Information (FOI) Fundamentals
    •Law: Public Law 89-487, 1966; Amended 1996
    •Regulation: 21 CFR 20
    The regulations govern the release of info by FDA per FOI •Guidance:  Handbook available at http://www.fda.gov/opacom/backgrounders/foiahand.html

    6. Are You Compliant?
    (Examples per Regulations)
    •21 CFR 50, 56, 312 Subpart D, and 11
    Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
    •21 CFR 200 Good Manufacturing Practice (GMP)
    •21 CFR 7 Enforcement
    •21 CFR 314.80 and 21 CFR 600.80
    Requirements for Post-marketing reporting for drugs and biologics

    7. Examples of FOI Requests Related to Regulations
    •Inspectional Observations (483’s)
    •Establishment Inspection Reports (EIRs)
    •Warning Letters •Approval Letters

    8.  Inspectional Observations – 483’s
    (http://www.fda.gov/ora/frequent/default.htm)• Excerpt from 483 to Company A:  The following observations are related to RPM No.: AACOO-07-26-02, entitled, "Mechanisms of Deep Inspiration-Induced Airway Relaxation." 1.This sponsor/clinical investigator failed to submit an IND to the FDA prior to conducting this clinical investigation, which involved the administration of hexamethonium bromide by inhalation to 3 human subjects. 2.The sponsor/clinical investigator failed to report an unanticipated adverse event to the IRB. The first subject in the study,     , was administered hexamethonium on 4/23/01. She developed a persistent cough from 4/25/01 till 5/3/01. The IRB was not notified of this event. 3.Failure to follow the protocol in that the protocol stated that hexamethonium would be administered by inhalation, when in fact; hexamethonium and sodium bicarbonate were actually administered to the second and third subjects.

    9. Establishment Inspection Report (EIR)
    [Excerpt of PDF image, redacted.]

    10. Warning Letter
    (http://www.fda.gov/foi/warning.htm)• Excerpt from Letter to Company A:
    •      This is regarding an inspection of your active pharmaceutical ingredient (API) manufacturing facility in Shizuoka, Japan by the United States Food and Drug Administration on May 15-18, 2001. The inspection revealed significant deviations from U.S. good manufacturing practices in the manufacture of APIs, and resulted in the issuance of a 29-item form FDA- 483 to you at the completion of the inspection. These deviations cause these APIs to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. Section 501(a)(2)(B) of the Act requires that all drugs be manufactured, processed, packed, and held according to current good manufacturing practice. No distinction is made between active pharmaceutical ingredients or finished pharmaceuticals, and failure of any to comply with CGMP constitutes a failure to comply with the requirements of the Act.
    •      We have also reviewed your June 27, 2001 written response to the FDA-483. We acknowledge the commitments to correct the deficiencies but the response does not provide documentation that any of the corrections have been successfully implemented.

    11. Approval Letter

    12. Helpful Hints for Writing Requests
    •Check other sources first (e.g., www.fda.gov)
    •Be specific (date ranges, drugs, application numbers, etc.)
    •Use correct terms (e.g., glossaries at http://www.fda.gov/fdac/special/newdrug/bengloss.html and http://www.fda.gov/ope/FY03plan/appA.html)
    •Discuss request with person making request in detail.  Rewrite request as needed before sending to FOI

    13. Further Reading
    •FOI Electronic Reading Room | http://www.fda.gov/foi/foia2.htm
    •FOI Index of Documents | http://www.fda.gov/foi/electrr.htm
    •FOI Handbook for Requesting Records