Fourteen pharmaceutical companies have received warning letters from the
Food and Drug Administration (FDA) about violating direct-to-consumer (DTC)
advertisement regulations in their paid links on Internet search engines.
In recent years the pharmaceutical and medical-device industries have been
aggressively expanding marketing campaigns into online media. The FDA has had
to step up its monitoring and regulatory actions in response (Psychiatric
News, March 20).
Sent on April 2, the most recent batch of warning letters from the agency's
Division of Drug Marketing, Advertising, and Communications targeted a number
of major pharmaceutical companies over dozens of prescription drugs they were
advertising online. The agency's objections focused on sponsored links and
accompanying short statements posted on Google that were intended to attract
Internet users to visit promotional Web sites for the products (see
The area highlighted in yellow in the above screenshot is an example of
a "sponsored link" on a Google search page for Lipitor. The
sponsor is Lipitor's manufacturer, Pfizer. This link has not been cited by the
Several drugs named in these warning letters are often prescribed in
psychiatry, including Forest Laboratories' acamprosate, escitalopram, and
memantine; Pfizer's pregabalin; Boehringer Ingelheim's pramipaxole; and Eli
Eli Lilly, for example, was criticized for suggesting the efficacy of
duloxetine in the online blurb "Learn about an SNRI for depression
called Cymbalta® (duloxetine HCl)," along with a link to the
product's Web site, without giving any information about potential adverse
events and safety risks. Forest Laboratories' links for several drugs,
including memantine, donepezil, and escitalopram, "inadequately
communicate[d] the drugs' indications ... and fail[ed] to use the
required" generic names.
The other warning letters cited similar problems with not including
adequate information about safety risks and complete indications.
The use of "sponsored links" that are posted on the pages of
Internet search engines has become a popular marketing strategy for companies
and organizations to promote their Web sites and products. It is inexpensive
and has the advantage of targeting advertisements to people who are already
looking for information about a particular product or related subjects such as
However, these sponsored links are given limited space (95 characters by
Google) for a statement to accompany the link. The FDA's warning letters have
made it clear that the agency is sticking to its rules for all public-access
pharmaceutical promotional materials and requires a complete and balanced
representation of both efficacy and safety information when a specific product
is advertised. Web sites' length limit for sponsored links is likely to make
it impossible for companies to go much beyond stating drug names.
As have other companies in other industries, pharmaceutical and
medical-device manufacturers have been testing various ways to expand their
online marketing presence. In addition to YouTube video postings and channels,
companies are making more use of online social networks such as Facebook and
MySpace to connect with consumers directly. For example, McNeil Pediatrics, a
division of Johnson & Johnson, has launched Facebook pages, or"
online communities," for adults with
attention-deficit/hyperactivity disorder (ADHD) and for mothers of children
with ADHD. McNeil's ADHD drug methylphenidate hydrochloride extended-release
tablets (Concerta) won FDA approval for treating adults in June 2008.
The FDA warning letters to pharmaceutical companies are posted at<www.fda.gov/cder/warn/warn2009.htm>.▪