1. Patient Involvement in the Development and Safe Use of
CIOMS XI
Patient Involvement in the
Development and Safe Use of
Medicines
Judith W. Zander, MD Director of Office of Pharmacovigilance and Epidemiology U.S. Food and Drug Administration April 19-20, 2018

2. Proposed Principles to Define Scope
Should be consistent with CIOMS Mission: propose limiting the scope to safety
Should address areas of current gaps and not include topics that are duplicative of or better addressed by other initiatives (e.g. ICH, IMI2 PREFER, WEB RADR etc.)
Should not include processes that are governed by national or regional legislation

3. FDA Current Practices Patient Perspective for Medicinal Safe Use
Clinical Development
Participation of a patient representative on all FDA Advisory Committee Meeting Panels
Open testimony by the public at all FDA Advisory Committee meetings and other public meetings and workshops
Voice of the Patient: Patient Focused Drug Development Initiative
Prescription Drug User Fee Act (PDUFA) > The Voice of the Patient: A Series of Reports from FDA's Patient-Focused Drug Development Initiative
Post Market Pharmacovigilance
MedWatch Online link: To report MedWatch online for Consumers (
MedWatch 3500B form: To report MedWatch on paper for Consumers. Also includes instruction (
MedWatch Learn for Consumers: This is an instructional video
Framework for benefit risk counseling to patients about drugs with a REMS
Research on Signal Detection in Social Media has not provided evidence additional benefit over traditional methods

4. Possible Gaps for CIOMS XI to Address
Drug Development and Risk Management:
Planning and Conduct of Clinical Trials including
safety communication with participants
approaches to safety data reporting from CT participants
ethical aspects for interactions and human protection
Risk Management
What risk management burdens are acceptable to patients
Extending concepts from CIOMS IX (? App for risk management)
Pharmacovigilance:
Methods for signal detection and evaluation from patient reported data from spontaneous reports and other data collection vehicles (PSP, registries)
Suggest future research on the best way to bring the patient perspective rather than individual patients perspective from a diverse community tor regulatory considerations
Additional research is needed to optimize signal detection from social media

5. Back up slides

6. What to Report to FDA MedWatch
Use the MedWatch form to report adverse events that you observe or suspect for human medical products, including serious drug side effects, medication errors/product use errors, product quality problems, and therapeutic failures for
Prescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient infusion centers
Biologics (including blood components, blood and plasma derivatives, allergenic, human cells, tissues, and cellular and tissue-based products (HCT/Ps)
Medical devices (including in vitro diagnostic products)
Combination products
Special nutritional products (infant formulas, and medical foods)
Cosmetics
Foods/beverages (including reports of serious allergic reactions)

7. What Not to Report to FDA MedWatch
Tobacco: Tobacco product problems should be reported to the Safety Reporting Portal Safety
Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS)
Investigational (study) Drugs: Report investigational (study) drug adverse events as required in the study protocol and send to the address and contact person listed in the study protocol
Mandatory reporting by regulated industry:
Drugs and Biologics
Applicable Regulations
Devices
Reporting on Dietary Supplements
Reporting on Veterinary Medicine Products
Reports FDA Does Not Handle (e.g. CPSC, FTC, State Health Departments) and where to send them)