FEATURE
Regulating DTCA
The regulations for broadcast DTCA follow those originally outlined for health-care provider – directed advertising , with a few additional conditions to satisfy the FDCA ’ s “ fair balance ” requirement , depending on the format or intent of the advertisement . The agency characterizes three types of DTCA : productclaim ads , reminder ads , and help-seeking ads .
“ Product-claim ads ” include the name and indication of the drug and make claims regarding its safety or efficacy . These materials must include a brief summary of the drug ’ s risk and are subject to the FDA ’ s most stringent regulations . “ Reminder ads ” name a drug but do not mention its indication , and “ help-seeking ads ” mention an indication but do not name a specific drug ; neither are required to communicate information about a drug ’ s risks . 7
A pharmaceutical company can submit drafts of an ad to the FDA for advance feedback but , for the most part , DTCA regulations only require that companies submit the materials to the FDA after they have been published or aired . 8
The agency acknowledges that not all companies take advantage of the preliminary review . And , even when companies do submit their ads , the materials may run for months before the FDA has the opportunity to review them . Often , the FDA finds out about misleading advertisements from health-care providers , patients , or competing companies . 8
When the agency does come across an advertisement that doesn ’ t abide by their guidelines – whether it suggests off-label uses for a drug , overpromises benefits , or doesn ’ t adequately address risks – officials typically send a warning letter or a notice of violation to the company . In rare cases , the FDA can choose to take other enforcement actions with more serious consequences , such as product seizures or criminal action . The agency has won lawsuits requiring GlaxoSmithKline , Abbott , Eli Lilly , and Pfizer to pay billions of dollars in penalties for miscommunicating information in DTCA . 9
Reading Between the Lines
In March 2018 , the FDA sent its first untitled letter ( indicating a violation that does not meet the threshold for regulatory action ) in three years to CSL Behring , citing misleading information in promotional materials for Idelvion , a recombinant coagulation factor IX concentrate to treat hemophilia B . 10 The ad , which appeared on the product ’ s website , patient brochures , and sales aids , depicted a person jumping and heading a soccer ball , suggesting that patients taking the drug could safely participate in such activities . However , playing soccer , especially hitting the ball with one ’ s head , is dangerous for people with hemophilia , even if they are being treated with the drug . The FDA gave the company 10 days to update their materials with more realistic imagery .
A May 2018 review of 97 drug ads ( representing 60 unique drugs ) showed that few broadcast ads adhered to all the FDA ’ s guidelines . 11 Thirteen percent advertised off-label uses and , while the authors did not find blatantly false information , they noted that many of the ads made claims that were potentially misleading . Materials presented information about risks in conjunction with distracting images , so viewers were likely to focus more on the imagery than the list of risks . Only one-quarter of the ads studied provided quantitative information about the drug ’ s benefits and none provided quantitative information about its risks . Drug efficacy , however , was presented quantitatively in 26 percent of ads .
Although the FDA has been sending fewer warning letters every year , researchers suspect this may be related to increased review requirements within the agency , rather than improved compliance among pharmaceutical companies . 5 Violations may go unnoticed by the public because the FDA lacks adequate funding and staff to respond to them : In 2008 , as a result of staff shortages , only 35 percent of broadcast DTCA materials had been reviewed . 5 Also , by the time everyone who needs to approve a violation letter has had time to review it , the advertisement or promotional materials may have been discontinued .
Disease-awareness campaigns sponsored by pharmaceutical companies “ blur the line between advertising and a public health campaign .”
— LISA SCHWARTZ , MD , MS
Finding New Loopholes
While the FDA may be struggling to keep up with reviewing traditional print and television ads , pharmaceutical companies are expanding their efforts and advertising in new ways , through internet ads and other “ patient education ” sponsorship opportunities .
In 2009 , the FDA sent warning letters to 14 pharmaceutical companies regarding banner ads , which represent a large portion of online advertisements . Most ads were cited for omitting information about the risks of taking particular drugs , overstating the drug ’ s benefits , or suggesting off-label uses . 12
Pharmaceutical companies have found ways around the DTCA regulations , though , like shifting their focus to the types of advertisements that do not require detailed information regarding a product ’ s risks and benefits : reminder ads that give a drug ’ s name but not indication , and help-seeking ads that describe an indication but do not name a drug .
Help-seeking ads take advantage of an important loophole in “ disease-awareness ” materials : When a consumer clicks a help-seeking banner ad , he or she is directed to a website dedicated to a particular company or brand of drug , providing the information that would typically classify it as a productclaim ad .
Because an estimated 60 percent of internet users search for medical information online , the potential audience for these advertisements is vast . 13 Consumers might be redirected to a website that includes information about a drug ’ s risk , but it is rarely found on the homepage . In other cases , pharmaceutical company – funded websites containing product claims masquerade as grassroots advocacy sites . 14 These websites don ’ t plaster the name of a drug across the homepage , but may include editorial content , podcasts , or videos featuring experts recommending the drug for a particular indication .
The growing use of social media also presents a unique challenge to regulating DTCA . Social media allows pharmaceutical companies to interact directly with consumers on their own Facebook pages , You- Tube channels , and Twitter profiles . Companies can produce both branded and unbranded content that , in turn , consumers can share with their personal networks . In addition , paid spokespeople can share content that isn ’ t obviously connected to the sponsoring company . 14
Social media and online advertisements have also paved the way for DTCA in countries where it has been banned . Even if the target audiences are residents of the U . S . or New Zealand , for example , there are no barriers that prevent residents of other countries from viewing the ads .
“ Use of the internet , social media , and mobile technology by firms to promote their prescription drugs has grown substantially in the last decade and continues to rapidly expand ,” an FDA spokesperson told ASH Clinical News . “ The FDA is taking the opportunity to work on guidance that considers new technologies and includes information about social science research to better reflect the agency ’ s current thinking on these issues .”
A Very Special Episode
In a move that some researchers consider even stealthier , drug companies have started using promotional tactics previously employed by disease advocacy organizations and public health initiatives to communicate their message .
A recent episode of the sitcom “ Black-ish ” raised concerns about this new type of pharmaceutical sponsorship . Series star Anthony Anderson was diagnosed with Type 2 diabetes in real life , a disease that can go undiagnosed for years and is common among African-Americans . Mr . Anderson is the face of a Novo Nordisk – backed awareness campaign called “ Get Real About Diabetes ” that encourages patients to talk to their doctors about managing the condition .
In a special episode of “ Black-ish ,” the character he plays receives a diagnosis of Type 2 diabetes , raising awareness about the disease among viewers . The episode specifically mentions that the disease disproportionately affects African-Americans , but this is no ordinary awareness campaign . Rather than working with a disease-awareness organization , Mr . Anderson partnered with Novo Nordisk to produce the episode . 15
Disease-awareness campaigns are intended to empower patients , not to expressly sell a pharmaceutical product , so the FDA has no authority over them . This type of content “ blurs the line between advertising and a public health campaign ,” according to Lisa Schwartz , MD , MS , co-director of the Center for Medicine and Media at The Dartmouth Institute , who studies pharmaceutical marketing . 16 Since there is no mention of company sponsorship in the television episode , she argued , viewers may lack a healthy skepticism about the information presented .
DTCA also is now headed to the stage : In July 2018 , the pharmaceutical company BioMarin announced that it is producing the first-ever musical about bleeding disorders , “ Breaking Through !” 16 BioMarin is working with Believe Limited , a creative agency specializing in educational and inspirational
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