1. FDA Notifications and Medwatch Form Requirements Adverse Event Reporting for OTC Drugs and Dietary Supplements

2. 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.

3. 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.

4. 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

5. 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).

6. 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.

7. 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.

8. Address for Medwatch Form Hard Copy Submission DIETARY SUPPLEMENTS: FAX NUMBER FOR ALL AEs: 1 800 332 - 0178 FDA Center Food Safety & Nutrition Office of Food Defense, HFS -11 5100 Paint Brach Parkway College Park, MD. 20740 OTC DRUGS: FDA Center Drug Evaluation & Research Central Document Room 5901-B Ammendale Road Beltsville, MD. 20705-1266

9. 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.”

10. Thank You For organizational training on adverse event reporting and FDA compliance, visit www.complianceonline.com.