11:28 Medical device industry is likely to face the same proposals for restrictions on direct-to-consumer (DTC) advertising as pharma, industry sources say
Story The medical device industry is likely to face the same proposals for restrictions on direct-to-consumer (DTC) advertising as the pharmaceutical industry, industry sources said.
Recent hearings on Capitol Hill concerning the practice of DTC advertising from medical device companies was a clear signal that the industry will be forced to deal with an issue that had so far been limited to pharmaceutical advertising, the sources said.
Sources admitted it had become nearly impossible to predict the legislative priorities for 2009, considering the economic meltdown and the uncertainty of the upcoming presidential and congressional elections. But they also said it was clear that device companies would be included in any discussion of DTC advertising practices within the pharmaceutical industry and that it was possible the sector would be dealt with before the larger pharmaceutical companies.
The Senate Special Committee on Aging heard testimony last month to consider recommendations on whether increased regulation of the practice is needed for devices such as heart stents, replacement hips, and other implanted devices.
The practice of advertising devices directly to consumers is fairly new, and relatively small compared to pharmaceutical companies, according to AdvaMed, the trade association representing medical device manufacturers. According to the organization, device companies spent just USD 116m in 2005 on DTC ads, while pharmaceutical companies spent USD 4.1bn.
But the focus on device manufacturers like Medtronic, Boston Scientific, Johnson & Johnson, and Abbott comes, at least in part, because of the dramatic increase in the practice over the last decade, according to Dr William Boden, professor of medicine and public health at the University of Buffalo.
Boden pointed out that there were only two producers of drug-eluting stents a few years ago, and companies only began to spend on advertising when several other players entered the market. Cordis Corporation, a Johnson & Johnson company, debuted an ad for its Cypher stent on Thanksgiving last year, he said. Companies like Stryker and Johnson & Johnson both currently use celebrities Jack Nicholas and Mike Krzyzewski to promote artificial hips.
The Committee on Aging has a history of getting the ball rolling towards considering legislation, according to an industry source involved in this issue in Washington. The source pointed out that hearings led by Sen. Larry Craig (R-ID) eventually led to the FDA reform bill that was defeated in 2007.
The source said that the hearings had drawn significant attention, and he expected it to be revisited next year. He said the device industry in particular was at risk because of the complexity of devices such as heart stents, and that they were more permanent than drugs. Boden agreed, and said for that reason he expects broadcast advertising to be targeted rather than print. Boden also recommended a two-year ban on advertising following a product's approval by the FDA.
John Kamp, executive director of the Coalition for Healthcare Communications, said Sen. Herb Kohl (D-WI) had written to Rep. Bart Stupak (D-MI) in the hope he would take up the issue. Kamp said he expects the issue to stick, and said he would not be surprised if the device manufacturers were included in legislation next year originally aimed at pharmaceutical companies.
Kamp pointed to comments from Rep. Rahm Emanuel (D-IL) indicating the Ways and Means Committee may look at a proposal to strip device and pharmaceutical companies of their tax write-off for advertising spending. Kamp said he expects the proposal to come up next year, though said it would almost certainly be challenged in the courts.
“It’s another indication that DTC is likely to be the subject of a lot of discussion and possibly legislation in 2009,” Kamp said.
A spokesperson for AdvaMed, however, argued for the continued use of device advertising. “The idea that a patient would undergo a complex and invasive procedure based on an advertisement, or that a physician would agree to perform them if inappropriate for the patient, is difficult to imagine,” the spokesperson said via email.
by Marc Longpre
Source Pharmawire
AI
