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

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

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.

Useful Consumer Information

• Comes in Many Forms

• Increases Patient Knowledge and Awareness about Disease States and Treatment Options

• Leads to Improved Health Outcomes

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

Information Available at Dispensing

• Medication Guides

• Patient Package Inserts

• Consumer Medication Information

Paperless Labeling

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

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 . . .

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

The Paperless LabelingTask 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

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

User Requirements

• Readily Accessible

• Timely – label updates will be provided daily

• Comprehensive

• User Friendly

• Standardized

• Printable

• Rapid access codes (“bar-coded”)

User Requirements (cont’d.)

• Text cannot be changed

• Virus protected

• Cost-neutral to dispensing site

• Available at all dispensing sites

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????

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 medicine’s effects.