(Boston, MA) — Community Catalyst and 22 other consumer, senior, patient safety groups and small insurers endorsed groundbreaking new FDA-proposed TV advertising guidelines in public comments filed today. The use of simple every day terms and a ban on distracting sounds or images are among the proposed reforms to help prevent consumers from being misled by TV drug ads. The groups also lent support to new proposed FDA standards to spell out drug risks and present them more slowly and prominently in broadcast advertisements, which are currently subject to laxer rules than print ads.
“Drug companies are quick to bury, downplay and mask the risks of drugs they advertise on TV with visual tricks, speed-talking, and scientific jargon,” said Wells Wilkinson, director of Community Catalyst’s Prescription Access Litigation project. “The FDA’s proposed rules go a long way toward curbing these tactics and helping consumers gain a better understanding of the very real risks associated with the drugs that companies promote during every sports game, newscast and popular show.”
In several areas Community Catalyst urged the agency go further in its rulemaking. Drug risks above a certain frequency should be quantified in commercials, the groups said. Citing consumer protection rules from the FTC, Community Catalyst recommended that the FDA require companies to tailor risk information to the consumer who might have the most difficulty understanding an ad—a “least informed viewer” standard rather than the “reasonable consumer” standard used by FDA in the past.
The FDA should also ensure that ads are more “neutral,” the groups said, by addressing the widely held myths that FDA approves all TV ads, and that the government only lets drugs that are “really safe” be advertised on TV. The groups propose that until Congress funds FDA’s program to review all TV ads, a disclaimer that “FDA has not approved this ad” should be required. The groups also asked FDA to include the adverse event hotline “Medwatch” number, which is currently featured in only print ads, in all TV ads.
Acknowledging that the number of ads to monitor outstrips the agency’s very limited resources, Community Catalyst said that until the FDA is given more resources to review ads and protect consumers, enforcement of these new standards may necessitate fines on drug companies.
Community Catalyst filed comments in collaboration with Alliance for Retired Americans, American Federation of State, County and Municipal Employees, (AFSCME), American Medical Student Association (AMSA), Breast Cancer Action, California Alliance for Retired Americans (CARA), CALPIRG, Coalition of Wisconsin Aging Groups, Consumers Advancing Patient Safety (CAPS), Connecticut Center for Patient Safety, Connecticut Citizen Action Group, Health Care for All, IUOE Local 4 Funds, Long Island Health Access Monitoring Project, MASSPIRG, National Women’s Health Network, New England Carpenters Health Fund, National Legislative Association on Prescription Drug Prices (NLARx), Oregon Health Action Campaign, Prescription Policy Choices, TeamstersCare, US PIRG, and VPIRG.
The group’s public comments can be found at: http://prescriptionaccess.org/publications?id=0003. The public comment period closes on Monday, June 28. Then FDA reviews the comments and issues final standards, which it says will go into effect 90 days later.
About Community Catalyst
Community Catalyst is a national non-profit advocacy organization dedicated to quality affordable health care for all. Since 1997, Community Catalyst has been working to build the consumer and community leadership required to transform the American health system. With the belief that this transformation will happen when consumers are fully engaged and have an organized voice, Community Catalyst works in partnership with national, state and local consumer organizations, policymakers, and foundations, providing leadership and support to change the health care system so it serves everyone – especially vulnerable members of society. For more information, visit www.communitycatalyst.org.
Prescription Access Litigation, LLC, is a project of Community Catalyst that confronts drug industry fraud on behalf of consumers, working with its coalition of over 130 consumer, health care advocacy, senior, labor and legal services organizations. www.prescriptionaccess.org.