NLARx Joins Consumer Groups to Applaud Tough New FDA Standards for TV Drug Ads

Hallowell, Maine - The National Legislative Association on Prescription Drug Prices (NLARx) joined Community Catalyst's Prescription Access Litigation and 21 other consumer, senior, patient safety groups and small insurers in comments endorsing groundbreaking new Food and Drug Administration (FDA)-proposed TV advertising guidelines in comments filed June 25th.

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.

"State legislators have many concerns about drug company television advertising," said Sharon Treat, NLARx Executive Director.  ""TV ads tend to gloss over the true risks of drugs, glamorize pharmaceutical responses when alternative medical interventions may be safer and more effective, and present scientific information in a confusing way."

Although states have attempted to regulate drug advertising, their actions are frequently challenged by industry lobbyists as reserved for federal regulators and thus potentially preempted.  Thus, although state legislators have significant concerns about both the potential health risks and the financial costs of increased drug spending resulting from direct to consumer TV advertising, their efforts to regulate are often stymied.

"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 NLARx and the other consumer groups 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 Federal Trade Commission, the comments 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.

In addition to NLARx and Community Catalyst, groups joining in the comments are 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, Oregon Health Action Campaign, Prescription Policy Choices, TeamstersCare, US PIRG, and VPIRG.

The public comments can be found here.  The public comment period closes on Monday, June 28. FDA will review the comments and issues final standards, which it says will go into effect 90 days later.