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Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

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Legal Framework of PADE Inspections

 

PADE Statutory Provisions / Regulations: Prescription Drug Products for Human Use

S.no FD&C Act, subchapter V, part A, section 505 (21 U.S.C. 355) Comments
1 21 CFR 310.305 New Drugs: Records and reports concerning adverse drug experiences (ADEs) for marketed prescription drugs for human use without an approved new drug application
2 21 CFR 314.80 New drug applications: Post marketing reporting of ADEs
3 21 CFR 314.81(b)(2) New drug applications: Annual reports
4 21 CFR 314.90 New drug applications: Waivers
5 21 CFR 314.98 Abbreviated applications: Post marketing reports
6 21 CFR 314.540 Accelerated approval of new drugs for serious or life-threatening illnesses: Post marketing safety reporting
7 21 CFR 314.630 Approval of new drugs when human efficacy studies are not ethical or feasible: Post marketing safety reporting
8 21 CFR part 4, subpart B Post marketing safety reporting for combination products

 

Approval vs. Marketing

Once a drug is approved, applicant holders MUST receive, evaluate, and report adverse drug experiences (ADEs) to FDA, even if the drug is not marketed.

PADE Inspection – Scope

  1. Written procedures
  2. Product list (approval date, status, etc.)
  3. Late or Missing Periodic Reports or Annual Reports
  4. Late, missing, incomplete, or inaccurate 15-day reports
  5. ADEs from all sources
  6. Root cause analyses and corrective actions for deviations
  7. Confirmations for electronic submissions
  8. Training Documents
  9. Safety Contracts, Agreements, and Business Partners
  10. Organization, roles, and responsibilities
  11. Waivers

Who can be inspected for PADE Compliance?

  1. Application holders: 

    Applicants with approved drugs and therapeutic biologics (prescription and non-prescription)

    • New Drug Application (NDA)
    • Abbreviated New Drug Application (ANDA)
    • Biologics License Application (BLA)

  2. Non- Applicants: 

    Manufacturers, packers, distributors, retailers, and certain others named on product labels (responsibilities vary based on product type)

    • Approved prescription and non- prescription drugs and therapeutic biologics (NDA, ANDA, BLA)
    • Unapproved prescription drugs
    • Unapproved non-prescription drugs

  3. Third parties: 

    Contractors, vendors, and other third parties

    • Pharmacovigilance activities conducted on behalf of application holders or non-applicants

Risk Based Selection for PADE Inspection

  1. Inspection History:

    • Compliance and inspection history

      • Never inspected for PADE compliance
      • Inspection findings from other program areas
    • Firm’s written responses to previous PADE inspections

  2. Firm Information:

    • Corporate changes
    • Portfolio (type and number of products)
    • Complaints
    • Internal FDA information
    • Information from other health authorities

  3. Product Portfolio:

    • New molecular entities
    • High-risk
    • Patient exposure
    • Recalls Submissions to FDA
      • Individual Case Safety Reports (ICSRs)
      • Annual reports
      • Periodic report