From: Ray Bullman [bullman@ncpie.info] Sent: Wednesday, November 05, 2003 1:08 PM To: fdadockets@oc.fda.gov Cc: Vicki Kao Subject: RE: Docket #2003N-0361 (Anti-Counterfeit Drug Initiative) RE: Docket # 2003N-0361 (Anti-Counterfeit Drug Initiative) The National Council on Patient Information and Education (NCPIE) has a long history of working closely with the U.S. Food and Drug Administration to boost health professional-patient communication about the safe, appropriate use of medicines. Since our founding in 1982, FDA has been a dedicated and active non-voting/liaison member of the NCPIE board f directors. In the past few years, NCPIE and FDA have collaborated on the development and dissemination of a number of timely consumer outreach campaigns, including: · “Think It Through: A Guide to Managing the Benefits and Risks of Medicines;” · “Buying Prescription Medicines Online: A Consumer Safety Guide;” · Be MedWise: Promoting the Wise Use of Over-the-Counter Medicines. NCPIE has reviewed the “FDA Counterfeit Drug Task Force Interim Report” (Oct. 2003) and is pleased to comment further on public outreach opportunities: · NCPIE has always advocated question-asking by consumers whenever they receive a prescription and/or whenever they fill a prescription. To help detect medicines that may be counterfeit, consumers should ask, “What will my medicine look like? How will it be packaged? How will I know if this medicine is working?” · After issuing a prescription, prescribers should inquire if a patient plans to purchase the medicine on-line; if so, they should be advised to “look for the VIPPS” seal (National Association of Boards of Pharmacy’s Verified Internet Pharmacy Practice Site). Unfortunately, this VIPPS seal is not well known among consumers. A simpler seal could be designed and heavily marketed. For example, see the “real” seal that appears on many dairy products (http://www.ilovecheese.com and http://www.realseal.com). The use of this “real” seal is coordinated by Dairy Management Inc., which handles certification of products that apply to use the seal. To further FDA’s communication outreach about counterfeit medicines, NCPIE recommends: a.. If the (potentially) counterfeit medicine is a product advertised via a current direct-to-consumer advertising campaign, FDA could urge manufacturers to modify ads (broadcast and print) with a small banner warning of the risk of counterfeit products. a.. FDA could place on-line banner ads warning about counterfeit products on the most popular health and medical websites, as well as on Yahoo! and Google.com. a.. FDA could aggressively court Hollywood to “place” messages about counterfeit medicines on prime-time medical and crime dramas, plus popular sit-coms like “Frasier,”etc. The National Institute on Drug Abuse (NIDA) regularly uses this approach, and there are medical consultants who specialize in working with Hollywood to place public health messages. In terms of maximizing existing communication tools, NCPIE recommends: a.. Reissue the CybeRx Smart Safety Coalition brochure, Buying Prescription Medicines Online: A Consumer Safety Guide, developed by NCPIE and the FDA in 2000. NCPIE, at the request of FDA, served as a convener of this initiative, bringing together a number of key pharmacy stakeholder organizations to develop the consumer brochure. Such organizations could be reconvened to update the message, to include information about how to avoid risks of counterfeit medicines. a.. CDER/OTCOM, in collaboration with key stakeholder groups, could develop a public transit and radio campaign for major cities / media markets. a.. (revisiting an idea proposed to FDA by NCPIE in August and September 1998 and April 2000) Formulation of a National Consumer Medicine Safety and Education Program similar in organizational structure to the “Fight Bac” public-private partnership for food safety education. As NCPIE proposed in the past, such a program could be launched in October to coincide with national “Talk About Prescriptions” Month. This observance (“TAP” Month), could be renamed by NCPIE to “National Medicine Safety and Education Month.” Timely and topical medicine safety and educational messages could be released by the campaign year-round, similar in approach to the “seasonal” food safety messages conveyed by the “Fight Bac” campaign. Thank you for providing this opportunity for the National Council on Patient Information and Education to comment on this important public health issue. Sincerely, Wm. Ray Bullman, M.A.M.Executive Vice President National Council on Patient Information and Education 4915 Saint Elmo Ave., Suite 505 Bethesda, MD 20814-6082 (301) 656-8565 - phone (301) 656-4464 - fax bullman@ncpie.info - email www.talkaboutrx.org www.bemedwise.org