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U.S. Department of Health and Human Services

Drugs

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Bad Ad Program: 2011-2012 Year End Report

Background

FDA’s Center for Drug Evaluation and Research (CDER) launched the Bad Ad outreach program in May of 2010 with the goal of encouraging health care professionals (HCPs) to recognize and report suspected untruthful or misleading prescription drug promotion. 

During the first year of the program, CDER’s Office of Prescription Drug Promotion (OPDP), formerly the Division of Drug Marketing, Advertising, and Communications (DDMAC), focused their efforts on educating HCPs about what constitutes misleading prescription drug promotion — from both a legal and clinical perspective — and providing them an easy process for reporting suspected violations to the FDA. This report is an update on year two of the Bad Ad program.

Building for the Future 

To build on the success of the first year, OPDP devoted significant time and resources in 2011–2012 to planning and developing tools that will drive the long-range sustainability and exposure of the Bad Ad program. The primary goal of the Bad Ad program is to raise health care provider awareness of how to recognize misleading prescription drug promotion and report it to FDA. Therefore, OPDP chose to focus efforts on activities that will establish FDA as the resource for the nation’s HCPs on information about misleading prescription drug promotion and create a culture of reporting such activity to the Bad Ad program.  To this end, OPDP discussed the value and educational mission of the Bad Ad program at the May 19, 2011, meeting of FDA’s Drug Safety Oversight Board (DSB). The discussions, feedback, and recommendations made by DSB members contributed to the current course of development of the program and will continue to influence future development for years to come. 

Three primary tools for achieving this culture of awareness and reporting were the focus of year two:

  • A web-based continuing education (CE) program for physicians, physician assistants, nurse practitioners, nurses, and pharmacists. Production of the course is moving forward and we anticipate completion before the end of 2012.
  • Case studies of misleading prescription drug promotion. These case studies will be made available as teaching tools to medical, physician assistant, nurse practitioner, nursing, and pharmacy schools. Together with the CE program, the case studies should provide a solid fundamental understanding of misleading prescription drug promotion to the nation’s future HCPs. Reaching HCP students with the Bad Ad message will increase awareness of how to report misleading promotion nationwide and have lasting impact as these HCPs progress throughout their careers.
  • OPDP developed a Bad Ad journal advertisement for placement in widely circulated HCP journals. Starting in May 2012, an advertisement for the Bad Ad program began running in the following publications:  Journal of the American Medical Association, American Family Physician, American Journal of Health-System Pharmacy, Journal of the American Academy of Nurse Practitioners, and Journal of the American Academy of Physician Assistants.

Through these activities, OPDP believes that the Bad Ad program can bring about a culture of awareness among the nation’s HCPs regarding misleading prescription drug promotion. By raising awareness and reporting such activities to FDA, OPDP and the health care community can work together to protect the public from untruthful and misleading prescription drug promotion.  

Further Raising Awareness Through Outreach

OPDP continues to reach out directly to HCPs to get their support in protecting the American public from untruthful or misleading prescription drug promotion. Numerous outreach activities over the past year have sought to raise awareness of misleading prescription drug promotion in the health care community. Below are key highlights of the program’s outreach activities during its second year of operation:

  • OPDP representatives staffed exhibits at eight medical conferences across the country, speaking with HCPs about how they can help stop misleading prescription drug promotion. OPDP representatives also conducted extended presentations at three U.S. teaching hospitals.

  • Throughout the fall and winter, OPDP representatives staffed an exhibit booth and hosted webinars and presentations to educate members of the American Medical Student Association, enhancing collaboration with medical students.

  • On December 16, 2011, Medscape hosted a webcast for HCPs on the Bad Ad program for its FDA Expert Commentary Series. This webcast has been viewed more than 5,000 times. The webcast is available at http://www.medscape.com/viewarticle/754890.

These efforts were intended to raise awareness in the medical community that HCPs can play a valuable role in helping FDA prevent untruthful and misleading prescription drug promotion.

The primary goal of the Bad Ad program is to increase awareness of misleading prescription drug promotion in the health care community. By raising awareness, we hope to deter drug promoters from violating the regulations regarding prescription drug advertising and promotion. 

Since the launch of the program, the Bad Ad section of the FDA Web site has been viewed approximately 56,000 times, and the number and diversity of reports received indicates that the program continues to be successful in raising awareness of untruthful or misleading prescription drug promotion. 

Regulatory Actions

OPDP has received hundreds of reports of potentially untruthful or misleading promotion since the program’s inception, all of which have been thoroughly reviewed and investigated. Over the course of this second year, OPDP has improved and refined its Bad Ad complaint review process to more quickly identify those complaints which require follow-up enforcement and those that serve to support ongoing surveillance activities.  FDA is encouraged by the number of reports received, as it demonstrates the consistent need for an easy-to-use reporting tool for misleading promotional activities.

OPDP took action on misleading prescription drug promotion when the appropriate evidence and standards were met and documentation was available.  For instance, the Untitled Letter for the drugs Chantix, Caduet, and Norvasc issued on August 31, 2011 (PDF), resulted from a Bad Ad complaint concerning a Lipitor Web page that discussed the efficacy of Caduet, Chantix, and Norvasc but did not include any balancing risk information about the drugs, including the most serious and frequently occurring risks. This was concerning as the pharmaceutical company previously received an Untitled Letter for a similarly violative promotion. 

The Saphris Untitled Letter issued February 28, 2012 (PDF), resulted from a Bad Ad complaint about a lunch promotional presentation where a physician speaker, presenting on behalf of a pharmaceutical company, made oral statements that suggested that the drug was safe and effective for an unapproved use. 

The EpiPen and EpiPen Jr. Warning Letter issued May 24, 2012, resulted from a record 33 complaints on a single advertisement to the Bad Ad program. As a result of the volume of complaints and the egregiousness of the violation, OPDP was able to contact the company and have the television advertisement pulled within three days of receiving the Bad Ad complaints. Following OPDP’s risk-based enforcement approach and taking immediate action allowed OPDP to prevent the misleading message from being more broadly disseminated. 

Future Plans

Based on the overwhelmingly positive feedback and response from the health care community, as well as direction from FDA’s federal partners and national leaders in the medical community, we will continue to expand our Bad Ad efforts with the goal of creating a culture of awareness and knowledge of misleading prescription drug promotion and how to report suspected violations. FDA will continue its development of a web-based continuing education program for the nation’s health care providers and continue to liaison with other health care organizations and institutions to further increase awareness of the program. Aligned with the program’s primary goal of raising awareness through education of HCPs, FDA will continue to pursue additional opportunities to collaborate with the nation’s medical, pharmacy, and nursing schools to enhance student education. OPDP will also continue direct outreach efforts by exhibiting at medical conferences across the country and spreading the Bad Ad message to HCPs around the country.

Thank You

 

Finally, FDA would like to thank each and every person who took the time to send a report to the Bad Ad program. These contributions have helped ensure the accuracy of the prescription drug information that both HCPs and their patients use to make treatment decisions.