FDA Notifications and Medwatch Form Requirements

Adverse Event Reporting for OTC Drugs and Dietary

Supplements

The Background – What You Need to Know

Adverse Event (AE) reporting regulations implement the

Dietary Supplement & OTC Drug Consumer Protection Act of 2006 (Public Law 109-462).

FDA regulations for adverse event reporting went into effect

in December 2007. Product label must contain the address (street address or P.O. Box) or

phone number at which company or other responsible person will receive a serious

adverse event report.

Serious Adverse Event (SAE) reporting is required for all

OTC Drugs and Dietary Supplements.

Products That Are Covered

All OTC monographed drugs (Rx to OTC drugs are already required to

report AEs).

All dietary supplements including vitamins, minerals, herbal or other botanical products, amino acids, or

any dietary substance used to supplement the diet by increasing the

total dietary intake.

When the Personal Care Products Safety Act becomes law, cosmetics

will also be covered.

Death: Report if the patient’s death is

suspected of being associated with use of

the product by the patient.

Life-Threatening: Report if the person was at

substantial risk of dying at time of the adverse event or if suspected that continued use of

product could result in a person’s death.

Hospitalization: Report if admission to the hospital was caused by or related

to an adverse event associated with use of

the product. Emergency Room treatment is

sometimes reported too.

Disability: Report if the adverse event resulted in

a significant or permanent change,

impairment or damage to the person’s body function/structure or

quality of life.

Spontaneous abortion, congenital anomaly or birth defect associated

with a product use must also be reported to the

FDA.

Definition of a Serious Adverse Event (SAE)

Section 761(a)(2) of the F,D, & C Act

FDA Notifications - Voluntary SAE Reporting

FDA encourages healthcare professionals to report serious adverse events to the agency for tracking purposes.

FDA’s Center for Food Safety & Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS) collects reports about adverse events and product complaints related to CFSAN regulated products, including foods, dietary supplements and cosmetics.

CFSAN encourages voluntary AE reports for cosmetics and conventional foods.

If a company receives a report of a serious adverse event, you should report it to CAERS even if reporting isn’t mandatory for the product (e.g. a food or cosmetic).

FDA Notifications

Many serious adverse events are reported to FDA directly by consumers, hospitals, or healthcare professionals.

If FDA receives a serious adverse event report about a company’s product they will contact you and you must keep that report on file. Often FDA notification comes with a request for more information and submission of a Medwatch form with product label.

Medwatch Form Requirements (Form 3500A)

Medwatch form must identify the injured person (name, age, sex, full address, etc.). Initials are used to protect privacy.

An identifiable initial reporter of the event.

Identity and contact information for the responsible party (i.e. the manufacturer, packer, or distributor representative submitting the AE report to FDA).

Name of the specific product that is suspected of causing the adverse event (not just a brand name).

Description of the serious adverse event with outcome.

Address for Medwatch Form Hard Copy Submission

DIETARY SUPPLEMENTS: FAX NUMBER FOR ALL AEs:1 800 332 - 0178

FDA Center Food Safety & NutritionOffice of Food Defense, HFS -115100 Paint Brach ParkwayCollege Park, MD. 20740

OTC DRUGS:

FDA Center Drug Evaluation & ResearchCentral Document Room5901-B Ammendale RoadBeltsville, MD. 20705-1266

Online Reporting of Medwatch Forms

Or http://www.fda.gov/Safety/MedWatch/default.htm

Go to the FDA website

(www.fda.gov), click on “Drugs” and enter “MEDWATCH form”.

Click on “Download form” or click on “Recalls & Alerts”

and see bullet called “MEDWATCH.”

Click on “Report serious adverse events online.”

Thank You

For organizational training on adverse event reporting and FDA compliance, visit

www.complianceonline.com.