Kohl Asks Rep. Stupak To Collaborate On Oversight Of Direct-To-Consumer Advertising For Medical Devices

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 29 Sep 2008 - 2:00 PDT

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Today U.S. Senate Special Committee on Aging Chairman Herb Kohl (D-WI) sent a letter to Congressman Bart Stupak, Chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations, regarding the subcommittee's letters to pharmaceutical companies over the implementation of temporary moratoriums on direct-to-consumer (DTC) advertisements featuring newly-approved drugs. In the letter, Kohl suggests that regulatory oversight should be at a commensurate level for both pharmaceutical and medical device DTC advertising, and that the House and Senate should work together toward that goal.

"I'm aware that your Subcommittee staff has done outstanding work in uncovering deceptive and misleading DTC ads sponsored by the drug industry, which has spent billions of dollars on such marketing efforts during the past decade or so," states the letter. "We would welcome any further exchange of information with the Subcommittee on this important matter, and we stand ready to work with you and your able professional staff in addressing these DTC advertising issues in a cooperative and bicameral manner."

Last week, the Aging Committee held a hearing examining issues related to direct-to-consumer (DTC) advertising for restricted medical devices that are regulated by the Food and Drug Administration (FDA), such as heart stents, replacement hips, and other implanted devices. Medical, advertising, and consumer experts shared with the committee their concerns about DTC medical device advertisements, including whether health risks are appropriately conveyed to consumers. Panelists also discussed how the current regulatory process for these ads can be strengthened.

Although Congress and the FDA have investigated DTC advertising for pharmaceuticals, little has been done to monitor medical device DTC advertising. Kohl concluded the hearing by promising to remain vigilant regarding the substance and balance of information that is directed to consumers about restricted medical devices. In his closing statement, Chairman Kohl said, "Already in the House, Chairman Dingell and others are asking for such moratoriums on DTC ads for pharmaceuticals. We've heard testimony this morning that similar restrictions may be necessary for DTC medical device ads."

Indicating that he would continue to remain involved with the issue, Kohl also added, "We are prepared to further examine the need for possible moratoriums… What we do in the near term will be dependent on the pro-active actions of FDA and industry."

Last week's hearing, entitled "Marketing or Medicine: Are Direct-to-Consumer Medical Device Ads Playing Doctor?," was part of an ongoing, fifteen-month series of oversight hearings Chairman Kohl has held on medical device and pharmaceutical marketing.

Special Committee on Aging
Senator Herb Kohl, Chair