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DTC Side Effects Include a Risk of State and Federal Crackdowns

1 Jun, 2009 By: Response Contributor Response


State Officials Fight Back


The Yaz case study illustrates a trend toward more stringent federal penalties, but it also speaks to the evolution of state-level pushback on misleading and potentially dangerous DTC pharmaceutical marketing.

More than 550 pharmaceutical-related bills are moving through state legislatures that span 41 states and Washington, D.C. One hundred new bills were created last year and 60 new laws and resolutions were signed into effect by December 2008, according to the National Conference of State Legislatures (NCSL). One thematic hot-button issue in these bills is to require marketers to tell the public how much they spend on marketing a product and whether or not they provide perks to doctors who prescribe them.

Livestrongs iPhone application, a calorie counter and fitness tracker, helps people monitor what they eat and how much they exercise when on the go.
Livestrongs iPhone application, a calorie counter and fitness tracker, helps people monitor what they eat and how much they exercise when on the go.


Washington, D.C.'s city/district-wide "Safe Rx Act," signed into law last year, requires pharmaceutical sales representatives to be licensed, to follow a code of ethics, and prohibits them from buying meals or giving gifts or incentives to doctors who might purchase their products.

Patient privacy is another aggressive battle being waged at the state level. The NCSL reports that New Hampshire paved the way in 2006 to protect prescription sales record information from being sold or redistributed for marketing purposes. In 2007, similar laws were signed in Maine and Vermont, and by 2008, 12 more states proposed to follow suit.

When Bayer was ordered to re-market Yaz, the decision was considered by many to be a state victory. Illinois Attorney General Lisa Madigan issued a public statement claiming her victory.

"This settlement reflects the continual monitoring my office performs to ensure that the pharmaceutical industry is not using deceptive marketing and advertising practices," Madigan said.

A vast majority of pharmaceutical marketers follow industry-wide best practices policies, which include voluntarily submitting marketing materials to be approved by the FDA. But with increasingly strict regulations maneuvering through federal and state courts, the face of the industry may be totally transforming.

"Some people think that pharmaceutical marketing won't even be recognizable in a few years because it will have changed so much because of the laws and because of actions by the state attorneys general, which become laws," says Maryann Kuzel, president of STAR Healthcare, a New York-based healthcare marketing agency. "Pharmaceutical companies are responding to the criticism in a very responsible way and the [pharmaceutical industry] guidelines show that, but the question now becomes what do we do?"


Vital Signs


While the pharmaceutical marketing landscape remains in constant flux, the industry as a whole received a clean bill of health from the Direct Marketing Association (DMA) in its 2008 report "Direct Marketing Facts and Figures in the Pharmaceutical Industry." According to the study, every investment dollar will yield a $10.27 return in DR-driven sales, and by 2012 the return is expected to reach $11, which means that in the next few years, direct response-driven pharmaceuticals sales will soar to $15.2 billion.

A budding trend is the use of online and E-mail marketing. The DMA claims that E-mail marketing will see the highest spike in marketing expenditures and Web-driven pharmaceutical sales will go from about $1.9 billion in 2008 to $3.8 billion by 2012.

"Pharmaceutical marketers have to start going where their consumers are and where the conversations are happening," says Kuzel.

Since pharmaceutical commercials are typically 30 seconds long, hardly enough time to disclose the benefits and legally required risks information, spots with prompts like 800 numbers and Web sites have trained consumers to remember the brand and then visit the Web site for more information.

"Advertising is great and it produces, on average, a 2-to-1 ROI," says Kuzel. "It helps people to identify or seek diagnostic testing and helps patients get diagnosed who otherwise wouldn't get diagnosed. So it helps raise awareness, but it's not the in-depth educational vehicle that the Internet can provide or you might see through a series of storytelling videos."

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