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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
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Compliance Risk Management and Surveillance
FDA/Center for Drug Evaluation and Research
Last Updated: December 20, 2007
Originator: OTCOM/DCRMS
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