Medical Device Daily Washington Editor

Washington – The first day of the advertising and promotions conference held by the Food and Drug Law Institute (FDLI; Washington) offered few surprises about the nature of violative promotions, but a few in the audience may have been surprised at comments ending the morning session. If several panelists who make their livings promoting drug products are to be believed, appropriately presented risk information does little to deter consumers from asking their doctors about a drug.

In his opening remarks, Wayne Pines, the president of regulatory services and healthcare at strategic communication consultant APCO Worldwide (Washington), noted that the new guidelines for pharmaceutical direct-to-consumer (DTC) advertising “seem to be having some impact on enforcement action.” Most of the emphasis in this area for the FDA, he stated, has been for web advertising rather than for television ads, “a trend that's [been] developing,” he commented. Ads that expand on the approved indication and those that do not adequately convey risk information are among the most frequent citations, which has historically been the case for letters coming from the Division of Drug Marketing, Advertising and Communication (DDMAC) at the Center for Drugs Evaluation and Research.

Devices, however, are not so easily promoted directly to consumers and Deborah Wolf, regulatory counsel at the Center for Devices and Radiological Health (CDRH), stated at one point in her discussion that when it comes to enforcing advertising and promotion regulations at CDRH, “our resources are limited.”

Off-label use of devices has crept further up onto the FDA radar screen, Wolf noted, describing the contents of an untitled letter that cited an unnamed company for promoting a “laser technology cleared for use for support of dental prostheses or single-tooth replacement” for other uses. Among these unapproved uses were for “stopping epithelial cell migration, securing gingival margins and bone heights.” The product was also promoted for “directing osteogenic cells to generate attachment of bone.”

One of the more egregious cases reviewed by Wolf was for a company selling surgical respirators as a defense against avian flu, SARS, anthrax, tuberculosis and pneumonia. The respirators have been suggested by the Centers for Disease Control and Prevention (CDC; Atlanta) as a prophylactic measure against these and other diseases for healthcare professionals, but CDC states on its web site that “infectious material deposited on a respirator may cause it to become a vehicle for direct or indirect transmission.” As a result, CDC recommends that “additional infection control measures…are needed,” something the sponsor of this sale neglected to mention.

Genetic testing has been offered on the Internet by means of a swab kit that is sent to the customer, then shipped back to a lab. Wolf said that “the center's jurisdiction is not entirely clear” in this case in part because swabs are not currently classified in such a way as to allow CDRH to go after such activities.

At the end of her presentation, Wolf told Medical Device Daily that jurisdiction for advertising and promotions of combination products will continue to fall to the agency that served as the lead reviewer for the product in question. She also had no comment about the prospects for regulation of advertising for nanoparticles if a company offers them for sale to drug makers.

Thomas Abrams, the director of DDMAC, said that his office issued 13 warning letters in the 12 months ending June 30, 2006, a jump from the average of five per year. Perhaps predictably, the most common violations were for inadequate risk information, misleading effectiveness claims and misleading comparative claims. One warning letter, addressed to Cytogen (Princeton, New Jersey) July 18, 2005, for Quadramet (samarium),… and fail to reveal and minimize important risk information.” The agency noted that it had contacted Cytogen in 2001 for “unsubstantiated efficacy claims.”

In the 2005 warning, the FDA stated that “the patient video makes statements that suggest that Quadramet is a cancer therapy that can provide therapeutic benefit other than pain relief” despite the fact that the product is approved as an analgesic for patients with osteoblastic metastatic bone lesions. The company's product insert for Quadramet also failed to note that urinary excretion would be slightly radioactive for several hours after administration and that measures to ensure safe disposal were called for, the FDA said.

In a discussion of the academic side of DTC advertising, panelist Ruth Day, PhD, the director of the medical cognition lab at the Duke University (Durham, North Carolina) department of psychology and neuroscience, observed that if a number of studies were any indication, most people, including doctors, “know and understand less” about drug products than they believe. When asked about DTC device advertising, her only response was a rhetorical “Where's the risk information?”

Day noted indirectly that primacy and recency of recall are still the key drivers of memory. She offered a chart that showed that the information presented midway through a television commercial was less memorable than the information appearing at the beginning and the end. Most of the advertising discussed in connection with this phenomenon provided risk information shortly after the halfway point in the commercial and phased it out by the time 80% of the commercial's duration had elapsed.

However, Ed Slaughter, the consumer and marketing manager at Merck (Whitehouse Station, New Jersey), was far from alone in noting that his data suggests that presenting risk information without visual distractions and other gimmicks did nothing to deter patients from asking doctors about a drug.