ASAP 2011 Annual Industry & Technology Issues Conference

1. ASAP 2011 Annual Industry & Technology Issues Conference On the Same Page? FDA, Brookings Institution and the Quest for a Single-Document Solution for Consumer Medicine Information and Medication Guides Ray Bullman Executive Vice President National Council on Patient Information and Education (NCPIE) January 20, 2011

2. An update on FDA’s collaboration with Brookings Institution FDA plan: develop, consumer test &require a single- document, manufacturer-prepared prescription medicine information (PMI) sheet developed under FDA guidance for all Rxs • New document intended to replace current Consumer Medicine Information (CMI) & Medication Guides • Multiple prototypes for consumer testing • FDA’s pilot testing plan

3. Relevant Chronology • Dec. 2008 - FDA final assessment of CMI • Feb. 2009 – FDA Risk Communications AC Meeting • Sept. 2009 – FDA public workshop (elements of useful CM; prototypes introduced) • May 2010 – FDA releases plan for consumer testing of PMI prototypes • July 2010 – 1st of 3 Brookings Institution (BI/FDA) Meetings (Workshop on prototype design, assessment and distribution) • Sept. 2010 (FDA Public Hearing – design / distribution of PMI) • Oct. 2010 -2nd of 3 BI/FDA Meetings (ensuring access to PMI) • Feb. 2011 – Final BI/FDA Meeting (prototype consumer testing) • Beginning of 2012 – FDA hopes to have data available

4. FDA’s Proposed Evaluation of PMI Effectiveness BI/FDA Meeting # 1 –July 2010) • Developing evaluation metrics & standards critical for implementing new PMI. • As many as 22,000 products that need PMI • FDA not resourced to individually review each PMI. • By setting clear, standardized metrics for evaluation, FDA can provide guidance to manufacturers for creating PMI.

5. About a Single DocumentBI/FDA Meeting #1 – July 2010 • Although there is no evidence on optimal page length, FDA firmly stated that PMI must stay within the single-sided one-page limit. • Decision based on concern of non-adherence to page limits from past experience, such as with MedGuides, where manufacturers exceeded specified page limits. • There are, however, several variable elements that might influence success of PMI, such as: order in which information presented, font choice, and font size -- all of which must be tested with patients to determine the best mix of elements.

6. RHEUTOPIA if we can create a successful PMI for a drug like this, we should be able to create successful PMI for drugs with much simpler profiles • Previously used for practicing converting professional labeling to the physician labeling rule format of 2006. Developed by medical officers with medical officer input; designed to be a very accurate conglomeration of a drug class; not a real drug, but shares many characteristics with the drug class that it was designed to represent. • Being used now because it is very complex. It has four indications: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. • Has boxed warning; would require a Medication Guide; injection rather than pill.

7. PMI Prototype “A”Chunked Bubbles of Information

8. PMI Prototype “B”Two boxed columns of information

9. PMI Prototype “C” Modeled afterOTC “Drug Facts” labeling

10. Future PMI Considerations(BI/FDA #1 – July 2010) • Paper-based PMI remains necessary and is not likely to disappear in the foreseeable future. However, several offered long-term visions for integrating technology with PMI distribution (e.g., patient portals and smart phones) • E-mailing PMI to patients seems to be the most realistic next step in the integration of PMI and technology. Anticipated this distribution method having minimal effect on format & content of paper-based PMI • Note: e-mail distribution presents additional considerations, such as an opt-in requirement, concerns about security of information, & patient privacy

11. FDA’s Proposed Consumer Testing Study to Evaluate the Prototypes Design includes three parts: • Live pretest: small sample of in-person testing (n = 180) • Internet with hard copy prototype: patients receive one of the prototypes in the mail and answer questions via the Internet (n = 900) • Internet with electronic prototype: patients have an electronic copy of the prototype and answer questions via the Internet (n = 200)

12. ISO ? FDA Prototype Testing • How these formats affect comprehension: As a whole as well as the comprehension of each individual section. Serious warnings -- when should you call your doctor, et cetera. • Risk perception: How risky do people think these drugs are when they receive this document? • Processing: What is the cognitive load in each document? How hard is it for people to get the information out of this sheet of information? • Order of information: How does the order of information affect risk perceptions and preference for the document?

13. FDA’s Research Design Phase 1 – Qualitative Phase: 90 1-on-1 face-to-face interviews with a number of populations that FDA may not get as much information out of, and may not be able to access as well in the quantitative phase of research (low literacy levels and also have a chronic disease that requires a drug with a bit more complicated mechanism than a pill) Also going to talk to people who have one of the indications that Rheutopia treats, primarily rheumatoid arthritis and plaque psoriasis. And finally, FDA will ask these questions of a general population sample.

14. FDA’s Research Design Phase 2 - Quantitative phase: A quantitative experiment where 1,300 people will be recruited and randomly assigned to conditions where each person will see only one of the prototypes or a Medication Guide for Rheutopia.This will be administered over the Internet. Research Design = 3- by-2-plus-1-plus-1; The main part of design is a 3-by-2, (two main variables, format which has three levels -- bubbles, columns, and OTC, and order, which has two levels, the warnings first or directions first. There are six main cells there, and there will be 150 people in each of these cells, plus there are a couple of additional cells. Continued

15. FDA’s Research Design Phase 2: Planning a control condition with 200 people in it where people receive the Rheutopia Medication Guide. Will also have another cell of people who will receive the prototype in paper form. Most people (1,100 people who participate in this experiment) will see prototypes imbedded within the Web design on the computer; 200 people will receive these in the mail so they'll have a piece of paper in front of them while they participate in the survey over the Internet At least 30 percent of the sample will be recruited to read at or below eighth grade.

16. Considerations from FDA “So we're going to move forward. We're no longer going to have PPIs, CMI medication guides, et cetera; we're going to move to the one-document solution that we all agree is long overdue.” “We are committed to a limit on length. We're committed to a page.” “So we have to think of another paradigm that will ensure the patients get the information they need when they need it, where they need it, and how they need it. And the likelihood is that we are going to put the burden on the manufacturer to make sure that a source document is created that comports with the approved product labeling.” “…and then somehow we have to make sure that as it travels from this source document to the patient that it's not sliced, diced, and somehow changed so that the meaning changes.” (Rachel Behrman, Office of Medical Policy, CDER, FDA (2nd BI/FDA Meeting, 10/10)

17. Contact Information Ray Bullman, Executive Vice President bullman@ncpie.info National Council on Patient Information and Education (NCPIE) 200-A Monroe Street, Suite 212 Rockville, MD 20850 (301) 340-3940 - phone (301) 340-3944 - fax www.talkaboutrx.org www.bemedwise.org www.mustforseniors.org