Direct-to-Consumer Advertising of Pharmaceuticals: An Integrative Review - Innovation and Marketing in the Pharmaceutical Industry - page 620

21.1.1 Recent History of DTCA in the USA

Detailed and excellent accounts of the history of regulation of DTCA in the USA
are available (for instance, Palumbo and Mullins 2002 ; Pines 1999 ), hence we limit
our discussion here to a few salient events in the regulated growth of DTCA.
Although the advertising of prescription drugs directly to consumers had always
been legal, US pharmaceutical companies advertised only to physicians till the early
1980s. The fi rst instance of a print advertisement directed to consumers is believed
to be in 1981 by Boots Pharmaceuticals for the ibuprofen product, Rufen. This was
followed by other drug companies who voluntarily submitted direct-to-consumer
(DTC) ads to the FDA. This shift in the marketing strategy and expenditures of
pharmaceutical companies from physicians to patients is a signifi cant development
and may be attributed to two kinds of forces. First, increasing limits on the effective-
ness of marketing to physicians, such as growth of managed care and their attempts
to contain drug costs, and growing restrictions on sales representatives' access to
physicians. Second, the social climate had changed in favor of patients having a
bigger say in their own health care and a greater desire for information, thereby
making advertising directed to patients potentially more effective. Camacho et al.
( 2010 ) note that there is a trend towards more participatory decision making, in
which doctors and patients together bear responsibility for medical decisions.
The FDA called for a voluntary moratorium on DTCA in 1983 while it studied this
somewhat unusual and unanticipated form of promotion. The moratorium was ended
in 1985. Thereafter, spending on DTCA continued to grow but at a slow pace. An
important aspect of the FDA regulations governing prescription drug advertising is a
requirement of a “brief summary” describing the effectiveness of the drug and its risks.
The brief summary must provide the drug's side effects, contraindications, warning
and precautions, as well as indications for use. While this requirement was easy to
satisfy in print advertising, it was too impractical for a 30-s TV advertisement. In a
major change to its regulation of DTCA in 1997, the FDA allowed a broadcast adver-
tisement to fulfi ll the brief summary requirements by reference to a telephone number,
a web site, a print ad, etc., thereby making it feasible to create a 30-s commercial. As a
consequence, spending on DTCA especially on TV has grown rapidly since 1997.
In 2005 the US pharmaceutical industry trade association, PhRMA (Pharmaceutical
Research and Manufacturers of America), announced voluntary guidelines for DTCA
practices. The guidelines are intended to address concerns about both the timing and the
content of DTC advertisements. These were revised in 2008 ( http://www.phrma.org/
sites/default/fi les/pdf/phrmaguidingprinciplesdec08fi nal.pdf ) and 26 companies have
become signatories to these guidelines.

21.1.2 DTCA Today in the USA: Expenditure on DTCA

DTCA expenditure on prescription drugs in the USA grew explosively, from $0.15
billion in 1993 to $4.07 billion in 2010 (see Fig. 21.2 ). In the last few years, expen-
ditures on DTCA have fallen from a high of $4.91 billion in 2007, consistent with a