1. Drug Information for Consumers and Healthcare Professionals Food and Drug Law Institute Annual Meeting Alan Goldhammer, PhD Associate VP Regulatory Affairs Pharmaceutical Research and Manufacturers of America

2. Importance of Communication An Educated Patient must be Goal #1 Improved Health Outcomes from Maximizing the Benefit and Minimizing the Risk is the Desired Result

3. Basis of all Communication FDA-Approved Drug Label is the synthesis of all the information acquired from the drug development program. It provides the important information that physicians need to treat their patients.

4. Useful Consumer Information Comes in Many Forms Increases Patient Knowledge and Awareness about Disease States and Treatment Options Leads to Improved Health Outcomes

5. Role of Integrated Consumer Education Campaigns Awareness Depth of Education Physician / Patient discussions Compliance Mass-reach advertising (TV/Print/PR) Websites, toll-free numbers, patient education Physician visit / Write Rx Patient education on use of product Each media has different strengths and purpose in comprehensive communication campaign

6. Information Available at Dispensing Medication Guides Patient Package Inserts Consumer Medication Information

7. Paperless Labeling Industry Initiative to Move Beyond Paper Prescribing Information to Deliver a Fully Implemented Electronic System at Every US Dispensing Site

8. The Current Regulation 21 CFR § 201.100 Prescription drugs for human use –A drug subject to the requirements of section 503(b)(1) of the act shall be exempt from section 502(f)(1) if all the following conditions are met: –(c)(1) Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including...

9. The Current Product Less than User-Friendly Current??? Bizarre sizes –the scroll –the newspaper –the wallpaper Mouse-size print Not always retained in pharmacies New FDA Rule to Require Longer Labels is Pending

10. The Paperless Labeling Task Force Proposal The current labeling for all marketed prescription products to be available electronically at no cost to all dispensing locations. PDF versions, using free software, available for viewing or printing. Bar-coded labels would allow direct access to product-specific labeling

11. Advantages to Proposal Pharmacists will have access to the most recent labeling –Public Health Benefit Labeling would be readable on screen Pharmacist can quickly scan to section of interest No possible product misbranding due to package insert mix ups

12. User Requirements Readily Accessible Timely – label updates will be provided daily Comprehensive User Friendly Standardized Printable Rapid access codes (bar-coded)

13. User Requirements (contd.) Text cannot be changed Virus protected Cost-neutral to dispensing site Available at all dispensing sites

14. Status and Next Steps Proof of Concept Test (summer 03) Large Scale Field Test ( Nov 04-Feb 05) Work with FDA and other stakeholders on full scale implementation Commercial Rollout in 2006????

15. Priority Goals Talk to your doctor, pharmacist, or other health care professionals. Know your medicines. Read the label and follow directions. Avoid interactions. Monitor the medicines effects.