The FDA's Truthful Prescription Drug Advertising and Promotion program aims to improve monitoring of drug promotions by encouraging healthcare providers to recognize and report misleading promotions to the FDA. The program will provide education to help providers identify violations and an anonymous reporting system. The goal is to increase oversight of promotional activities like sales representative presentations and speaker programs that the FDA has not traditionally been able to closely monitor.

1. The FDA’s Truthful Prescription Drug Advertising and Promotion (“Bad Ad”) Program

2. The role of DDMAC FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) aims to ensure that all prescription drug promotion is truthful, balanced, and accurately communicated. Promotions it regulates include Sales representative presentations Speaker program presentations TV and radio advertisements All written or printed drug promotional materials Source: FDA website http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm211791.htm

3. DDMAC enforcement efforts Traditionally, DDMAC has monitored prescription drug promotions through Review of promotional materials submitted by companies Investigation of complaints about drug promotions Close observation (surveillance) of drug promotions at large medical conventions Review of promotion using the Internet Source: FDA website http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm211791.htm

4. Shortcomings of current system Under the current system, lack of access has limited DDMAC’s ability to monitor promotional activities that occur in settings such as Physicians’ offices Local dinner programs Promotional speaker programs Source: FDA website http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm211791.htm

5. Increasing the effectiveness of DDMAC's surveillance program Truthful Prescription Drug Advertising and Promotion (“Bad Ad”) Program The program is designed to improve DDMAC’s ability to regulate promotional activities to which it historically has had limited access The program will help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency The FDA will implement an educational outreach program designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading Source: FDA website http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm

6. What the FDA is asking physicians to do Recognize and report According to the FDA, the prescriber can play an important role in ensuring that prescription drug advertising and promotion is truthful by recognizing and reporting misleading drug advertising and promotion Recognize The FDA is asking physicians to be aware of the many advertisements and promotions that they see every day Report The FDA is asking physicians to help stop violations by reporting activities and messages that they consider false or misleading Source: FDA website http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm

7. Educating physicians on their role DDMAC will have a booth at some of the major medical conferences starting in May of 2010 DDMAC reviewers will be speaking with prescribers regarding how to recognize misleading prescription drug promotion and how to report any potential violations to the FDA In-service training sessions with large group practices and hospitals are also available Source: FDA website http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm211498.htm

8. Reporting a violation Violations can be reported by phone, fax, e-mail, or written letter Complaints can be filed anonymously Complaints will be reviewed by a Regulatory Review Officer responsible for the class of drugs being reported to ascertain if a violation has taken place and, if so, what the appropriate course of action is Source: FDA website http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm

9. Questions about the program Will doctors be able to recognize a violation? Many doctors will not be able to attend FDA-led training sessions Does the FDA have the resources to follow up on reports effectively? If there are a large number of reports, the FDA does not have the manpower to address them Will the anonymous reporting system be misused? Physicians who dislike reps, competitors trying to trash each other, and individuals frustrated with the healthcare systems could potentially file unfounded complaints