Healthy Skepticism Library item: 18659

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Magazine

Heavey S, Richwine L
FDA struggles to keep up with pitches old and new
Reuters Magazine 2010 Sep
http://static.reuters.com/resources/media/editorial/20100903/FDAMarketing.pdf

Abstract:

Under the Obama administration, the
FDA has vowed to crack down on the
drug industry’s increasingly aggressive
marketing tactics, both online and off.
But with just 57 officials charged with
viewing some 75,000 ads a year, there is
only so much the agency can do.

Full text:

It wasn’t what you would call a casual get-together.
In February 2009, a popular New York blogger attended a brunch
with fellow “frazzled moms.” They took in tips from a style expert and
listened to a nurse extol the virtues of Mirena, a birth control device
sold by Bayer Healthcare.
The nurse was on Bayer’s payroll. In a series of events organized with the
help of a women’s website, Mom Central, the pharmaceutical company
gathered a captive audience of young mothers. It provided the nurse with
a script and had the women fill out a survey before they left.
The sessions earned a stern rebuke from the U.S. Food and Drug
Administration. In a letter to Bayer Healthcare made public earlier
this year, the agency faulted the drugmaker for telling “busy moms”
that using its intrauterine device (IUD) “will result in increased levels
of intimacy, romance and, by implication, emotional satisfaction.”
Besides hyping the product, the nurse failed to disclose potential
risks. “Here you have a company hiring a third-party to invite people
into a home like a Tupperware party,” said Thomas Abrams, whose
department oversees pharmaceutical marketing reviews at the
FDA. “That was extremely, extremely concerning to us because this
product has risks — risk of infection, loss of fertility. Huge risk.”
Under the Obama administration, the FDA has vowed to crack down
on increasingly aggressive marketing tactics — both online and off.
But even Abrams acknowledges the agency lacks the resources to
sharply curtail misleading drug ads.
Downturn or no, the pharmaceutical industry hasn’t been skimping
on advertising. In 2009, companies spent a vast $4.8 billion to reach
out to consumers in the United States — the only country besides New
Zealand that allows direct-to-consumer advertising — up from nearly
$4.7 billion the year before, according to tracking firm Kantar Media.
To drug companies, it is all part of patient education. But consumer
advocates, some lawmakers and others see the barrage of ads as a
way to push medicines that people may not need as well as raise the
nation’s overall healthcare costs.
As media splinters into a sea of Internet blogs, on-demand television
and niche publications, companies are racing to keep pace. Websites
and digital technology offer powerful tools that make it easier,
cheaper and quicker to target specific groups. And drugmakers are
relying more on celebrities and other methods to make their products
stand out.
For example, last year the FDA warned Abbott Laboratories over a
promotional DVD featuring former basketball star and HIV patient
Earvin “Magic” Johnson that the agency said suggested the company’s
HIV drug Kaletra was safer and more effective than proven.
Agency staff have also slapped Allergan Inc for its website promoting
its eyelash-boosting drug Latisse, saying various webpages did not
tell potential consumers about possible risks, such as extraneous hair
growth if the product touches the skin elsewhere, and downplayed
possible allergic reactions. …