Division of Compliance Risk Management and Surveillance

Adverse Drug Experience Reporting 

On December 23, 2007 a significant change to the postmarketing reporting requirements for drug products goes into effect. Chapter VII, SubChapter H, Section 760 of the Food, Drug, and Cosmetic (FD&C) Act establishes new adverse event reporting requirements which apply to the manufacturers, packers, and distributors whose names appear on the labels of over-the-counter (OTC) or behind-the-counter (BTC) drugs marketed in the United States. Please see links below for reference documents related to these new requirements.

To ensure consumer safety, the FDA collects information on adverse drug experiences that occur after a prescription medication is approved or marketed. The Division of Compliance Risk Management and Surveillance enforces the Postmarketing Adverse Drug Experience (PADE) Reporting Requirements in an effort to ensure that the FDA is receiving data on rare, latent, or long-term drug effects not identified in premarket testing. The division also ensures that PADE reports are accurate, complete, and submitted in a timely manner. The division communicates the agency's compliance expectations to the pharmaceutical industry through outreach efforts, including presentations to various industry associations and agency counterparts and training sessions at the FDA’s Basic Drug School for investigators.

Drug firms, health care professionals, and consumers submit PADE reports to FDA for domestic and foreign adverse events associated with FDA-regulated drug products. Based on these reports, the division identifies domestic and foreign firms, including New Drug Application holders and drug manufacturers, packers, and private-label distributors, for inspection. The division uses a risk-based approach to identify firms for inspection that focuses on drugs that pose a significant health risk to consumers and other priority issues affecting the public’s health. The findings of the inspections are evaluated to determine if regulatory action is necessary.

Drug application holders and certain manufacturers, packers, and distributors for prescription and non-prescription drugs are required to submit specific adverse event and drug safety information to FDA. These requirements are set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Title 21 of the Code of Federal Regulations (CFR). Final and draft guidances are available which clarify the FDA's expectations for meeting the regulatory requirements.

Related Resources

• Dietary Supplement and Non-prescription Drug Consumer Protection Act. The legislation establishing the new requirements for reporting adverse events associated with the use of dietary supplements and non-prescription (OTC) drug products.
• Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed without an Approved Application [PDF] or [HTML]. The draft guidance clarifying how to submit reports of serious adverse events associated with unapproved over the counter drug products.
• Adverse Event Reporting System web site. The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products.
• AERS Electronic System for Submitting Adverse Drug Reaction Reports. This site provides information on submitting AERS reports using electronic files, not paper report forms.
• MedWatch Site – Mandatory Reporting by Manufacturers, Packers, and Distributors. This site provides reporting forms and instructions, applicable regulations, and guidance for industry and Agency field staff for MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.
• CFR Part 310, Sec. 310.305 – Records and Reports Concerning Adverse Drug Experiences. Links to the applicable section of the Code of Federal Regulations regarding records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
• CFR Part 310, Sec. 314.80 – Postmarketing Reporting of Adverse Drug Experiences [Products with NDA approvals]. Links to the applicable section of the Code of Federal Regulations regarding postmarketing reporting of adverse drug experiences, including definitions and submission and review of reports.
• CFR Part 310, Sec. 314.98 – Postmarketing Reporting of Adverse Drug Experiences [Products with A(NDA) approvals]. Links to the applicable section of the Code of Federal Regulations regarding postmarketing reporting for drug products with abbreviated new drug approvals (A(NDA)s).
• CFR Part 310, Sec. 314.81 – Other Postmarketing Reports. Links to the applicable section of the Code of Federal Regulations regarding other postmarketing reports, including the Annual Report.
• CFR Part 211, Sec. 211.198 – Complaint Files. Links to the applicable section of the Code of Federal Regulations regarding written and oral complaints about a drug product.
• CFR Part 310, Sec. 314.90 – Waivers. Links to the applicable section of the Code of Federal Regulations regarding obaining a waiver from the CDER Office of Surveillance and Epidemiology for postmarketing reporting requirements.
  Waiver requests should be sent to:
  
  Gerald Dal Pan, MD, MHS
  Director, Office of Surveillance And Epidemiology
  Central Document Room
  CDER/FDA
  5901-B Ammendale Road
  Beltsville, MD 20705-1266
  Attn: Waiver request