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Reforms needed in drug advertising to reflect safety concerns, FDA told

Tuesday, Nov. 1, 2005

DTC Reforms Needed to Hold Advertisers Accountable for Misleading Drug Ads; Improve Consumers’ Understanding of Risks, Benefits
Consumers Union outlines proposals for FDA panel on drug ads

(Washington, D.C.) – Consumers Union today outlined major reforms to direct-to-consumer prescription drug advertising for an FDA panel examining the issue, including calling for a moratorium on new drug ads for up to three years, pre-approval of ads to ensure they accurately convey the benefits as well as the risks, and monetary penalties to help enforce truth-in-advertising laws.
Bill Vaughan, senior policy analyst, submitted the testimony as part of a two-day hearing on the status of Direct-to-Consumer Drug Advertising.
“Current ads often fail to present the benefits and risks of using prescription drugs or medical devices in an accurate, non-misleading, balanced, and understandable way,” Vaughan said.
“Because the emphasis at the FDA is getting drugs quickly to market, the agency often doesn’t fully know the safety implications of some of these drugs,” Vaughan said. “The FDA shouldn’t allow advertising of these new drugs to millions of consumers until it has a clearer understanding of the risks.”
Consumers Union supports:
• A 2- or 3-year moratorium on advertising of new drugs given the often accelerated approval procedures that test drug safety for only a limited time, and the lack of post-market safety studies being conducted;
• Pre-approval of direct-to-consumer (DTC) and direct-to-provider (DTP) ads before they are presented to the public and providers, so as to end the long history of misleading marketing that overstates benefits and understates risks. If pre-approval is not possible, then there should be substantial penalties for misrepresentation of the safety risks;
• S. 930 (Grassley-Dodd) requiring that ads for those drugs approved on the condition of further studies publicly identify that safety concerns have been identified and are being investigated;
• Legislation giving the FDA civil monetary penalty authority to effectively enforce truth-in-advertising and penalize repeat offenders;
• Requiring an addition to all DTC ads, noting that all adverse reactions should be reported to a physician and the FDA at MedWatch, and give the toll-free telephone number and Web address of MedWatch;
• Ensuring that if or when PDUFA is re-authorized in 2007, enough resources are dedicated to review of DTC and DTP ads so as to make the program truly effective; and
• Developing a system where drug manufacturers may support an objective public service announcement fund to educate the public about under-treated and under-diagnosed diseases and conditions.
“The public wants quick access to possibly life-saving drugs, but they also want them to be safe. Achieving these goals is possible, but it will require the FDA give as much attention and resources to drug safety as it gives to speeding up the approval of new drugs,” Vaughan said.
To read the complete comments, click here.
Contact: Bill Vaughan, 202-462-6262