In testimony before the Senate Commerce Subcommittee on Consumer Affairs, Dr. Michael Shaw, EthicAd’s Executive Director, stressed the need for voluntary industry standards to assure that direct-to-consumer (DTC) advertising is reliable, unbiased and trustworthy. “Most pharmaceutical companies approach DTC in a responsible and ethical manner,” Dr. Shaw said, “but other companies focus on DTC primarily as a mechanism to drive sales. This disparity can mislead the consumer. Consumers have no way to differentiate between educational programs promoting their own welfare and programs designed just to promote the welfare of the sponsor.”
EthicAd is an independent non-profit organization composed of leaders of the academic healthcare community. Heart surgery pioneer, Dr. Michael DeBakey, serves as Chairman Emeritus of EthicAd, whose members include other prominent scientists, many of whom have worked closely with industry in the development of professional education programs.
“Through DTC advertising of Rx drugs, manufacturers have become health care information providers just like doctors or hospitals,” Dr. Shaw said. “If they are assuming the role of educating the public directly about the safe and appropriate use of its medicines, they have the responsibility to give them all the facts. FDA is the American public’s best protector, but doesn’t have the resources to do it alone. Non-profit organizations like EthicAd can help industry and government regulators by working cooperatively to formulate standards to better educate the public. We also can make available a ‘good seal of approval’ to insure that appropriate consumer standards are met.”
EthicAd spent a year working with representatives from the regulatory community, pharmaceutical industry, consumer groups and health care organizations to develop the EthicAd DTC Standards. Those Standards are designed to insure accurate content, clarity, consumer understanding, and public health benefit. They might provide a prototype for the pharmaceutical industry to take self-regulatory steps to assure that their actions are compatible with what Americans expect from health care providers. “FDA rules require truthful information that is fairly balanced. Those rules don’t insure that the information is developed with the consumers’ best interest in mind. They also don’t require industry to consider public health as an important factor in developing DTC information,” Dr. Shaw said. “We don’t need burdensome new legislation or regulations. What we do need is an opportunity for industry to adopt its own voluntary standards to reassure the American people that they can trust the information bombarding them through every medium of advertisement. The EthicAd Standards are a good starting point. They are based on recommendations received from industry, regulators, health care professionals and consumer groups,” he added.