The United States Senate Special Committee on Aging heard testimony Sept. 17, 2008, to consider recommendations on whether increased regulation of direct-to-consumer (“DTC”) advertising is needed for restricted medical devices regulated by FDA, such as heart stents, replacement hips, and other implanted medical devices. (The Federal Trade Commission regulates advertising for non-restricted medical devices.)
Describing its inquiry as “Marketing or Medicine: Are Direct-to Consumer Medical Device Ads Playing Doctor?” the hearing was another in the committee’s on-going, 15-month series of oversight hearings on medical device and pharmaceutical marketing practices. Committee Chairman Sen. Herb Kohl (D-Wis.) observed in his opening remarks that the pharmaceutical industry has spent “billions of dollars advertising their products directly to consumers” since the mid-1990s, while the medical device industry is “just beginning to get into the game.” (According to AdvaMed’s President and CEO, Stephen J. Ubl, pharmaceutical companies spent $2.46 billion on DTC ads in 2005 while medical device companies spent $116 million.)
Whether the Committee is poised to act is unclear. In his opening statement, Sen. Kohl said that, depending upon what his committee learned during the hearing, he was prepared to work with Rep. John Dingell (D-Mich.) to consider legislative measures similar to the American Medical Association (“AMA”) 2006 call for enhanced regulation of DTC advertising by FDA. At the conclusion of the hearing, however, Sen. Kohl said that “we’re not yet of a mind to propose legislative solutions,” although he plainly indicated that he, his committee, and staff members would stay “very, very much on top” of this issue.
CDRH Overview of Existing Regulation of DTC for Devices
Daniel Schultz, M.D., Director of FDA’s Center for Radiological Health (“CDRH”), provided a comprehensive overview of current medical device DTC regulation for the Committee. FDA’s device regulations do not contain specific requirements regarding the content of advertisements for restricted medical devices, in contrast to regulations for prescription drug advertising. Regulation of restricted device advertising comes directly from the Federal Food, Drug and Cosmetic Act – specifically sections 502(q) and (r). These sections provide that a restricted device is misbranded if its advertising is false or misleading in any particular, and does not contain a brief statement of the device’s intended use and relevant warnings, precautions, side effects, and contraindications. Dr. Schultz explained that the FDA’s February 2004 Guidance Document is intended to help companies comply with the statutory requirements.
CDRH regulates only two of the three different types of DTC device ads – the “product claim” and the “promotional reminder” ads. “Product claim” ads are those that generally include both the name of a product and its indications for use, or make a claim or representation about a medical device. “Promotional reminder” ads may disclose the name of the medical device and certain descriptive information or price information, but they do not give the device’s indications for use or make any claims or representations about the device.
The third type of DTC device ad – “help seeking and disease awareness communications” – does not constitute labeling or advertising and, therefore, is not subject to FDA regulation. Disease-awareness communications discuss a particular disease or health condition and are disseminated to health care practitioners, while help-seeking communications are essentially disease-awareness communications directed to consumers. Neither mentions any specific device or makes any representation or suggestion concerning a particular device.
CDRH’s Office of Compliance (“OC”) is responsible for the surveillance and enforcement of violations contained in the promotional materials of all medical device companies. Dr. Schultz noted that the OC’s primary source of promotional violations by device companies comes from competitors and information obtained by OC personnel who attend various science meetings at which devices are discussed and exhibited. In general, OC’s involvement is limited to circumstances after the materials have appeared in the public domain.
Hearing witnesses came from the medical profession, advertising and consumer protection groups, FDA, and AdvaMed. While all agreed that DTC advertising of medical devices is an important issue, there was no agreement about whether device ads should be regulated, or regulated in the same manner and to the same degree as those for prescription drugs.
For example, Dr. Schultz agreed with Sen. Kohl that regulation of DTC advertising for medical devices is “important,” but declined the senator’s invitation to answer a question in the affirmative about whether there should be the same level of regulation by FDA for prescription drug and medical device DTC ads. Dr. Schultz, who described himself as “a surgeon and a device guy,” said medical devices “need to be regulated to the extent necessary to protect public health,” noting that the real issue is how FDA accomplishes such a mission and whether it does it efficiently. Dr. Schultz said that FDA and CDRH will look at whatever ideas the committee has to offer and provide comments on what it believes will be “effective regulation.” Making a strong statement for the value of the “learned intermediary,” Dr. Schultz said that “[a]t the end of the day, the ultimate decision of what is the best treatment rests with the doctor and the patient.”
The witnesses from the medical profession supported greater FDA oversight of DTC advertising for medical devices, combined with greater restraint by device manufacturers in using DTC advertising. In fact, when asked by Sen. Ken Salazar (D-Colo.) whether Congress ought to consider banning DTC advertising as other countries have done, William E. Boden, M.D., professor of medicine and public health at the University of Buffalo, said that “most would prefer it,” although he did not explain precisely who was included in the term “most,” and acknowledged that such an action would likely trigger court challenges. Dr. Boden concluded his response by saying that “it [the ban] would be worthy of consideration if you could navigate around the First Amendment issue.” Ruth Day, Ph.D., a witness from Duke University, interjected that other countries have not banned DTC advertising; rather, they simply have not approved it.
Kevin J. Bozic, M.D., M.B.A., an orthopaedic surgeon from the University of California at San Francisco, spoke on behalf of the American Association of Orthopaedic Surgeons. He is the co-author of a 2007 study critical of the impact of DTC advertising in orthopaedics (Bozic, K.J., Smith, A.R., Hariri, S., et al. “The Impact of Direct-to-Consumer Advertising in Orthopaedics,” Clin Orthop Relat Res.2007; May: 458:208-19). The study surveyed practicing orthopaedic surgeons who perform hip and knee replacement surgery and patients who were scheduled to undergo such surgery. The study concluded that DTC ads had a substantial influence on both patient and surgeon decision-making. At the same time, Dr. Bozic acknowledged that more studies are necessary to evaluate the effects of DTC advertising on physicians and patients.
In contrast to Dr. Bozic, Dr. Boden emphasized that, given the sophisticated medical understanding required for devices used in interventional cardiology, it is extremely unlikely that a lay person would possess such an understanding on the basis of a 30-second television ad. As Dr. Boden put it in his written testimony, “[i]t seems highly unlikely that an interventional cardiologist would accede to a patient’s request for a particular stent type, based solely on the patient’s very limited information derived from a DTC ad that touts one particular [stent].”
Among his recommendations, Dr. Boden believes that FDA should place drugs and devices on the same regulatory footing with respect to DTC advertising, requiring evidence-based clinical data to demonstrate proved clinical benefits of the device being advertised. In this vein, Dr. Boden alluded to the model developed and used by New Zealand. In that country, all ads making therapeutic claims for advertised products must first be pre-approved by the Association of New Zealand Advertisers, Therapeutic Advertising Pre-Vetting Service, which promotes an industry-based, self-regulatory advertising code of conduct that encourages fair balance of risks and benefits in advertising content. Dr. Boden suggested that the FDA establish a similar panel under the Federal Advisory Committee Act that could either itself recommend standards for DTC device ads, or develop a new set of standards for self-regulation. Finally, Dr. Boden favors a ban on all DTC device ads for the first two years following FDA approval to assure that an appropriate safety record is established prior to advertising to the public.
Dr. Day, the Director of the Medical Cognition Laboratory at Duke University and Senior Fellow at the Duke Center for the Study of Aging, testified about research into how people understand and remember information in DTC advertising. She opined that it was important for both benefits and risks to be presented in “cognitively accessible” ways.
Not surprisingly, a witness from Consumers Union urged Congress to require FDA to conduct the same kind of oversight and regulation of DTC ads for implantable medical devices as the agency is now authorized to do for drug ads, and called for Congress to require FDA review of DTC device ads prior to being issued.
The final witness of the day was Mr. Ubl from AdvaMed. He stressed four key points in his testimony. First, AdvaMed’s member companies believe strongly that DTC advertising of medical devices must provide truthful and non-misleading information to consumers. Second, such advertising can benefit the public health by informing patients of important potential therapies that they should discuss with their physicians. Third, FDA and FTC already have ample legal authority to regulate false and misleading advertising for medical devices, and AdvaMed believes that FDA resources in this area should be focused on enforcement issues. And fourth, concerns about DTC advertising in the drug context are in many cases less relevant when applied to restricted devices, which not only are prescribed by doctors but are used or implanted by doctors as well.