How DTCA Influences Prescription Pharmaceutical Markets - Innovation and Marketing in the Pharmaceutical Industry - page 642

discuss the relative effects of DTCA and DTP activities. We illustrate the differences
between DTCA and DTP with an original analysis of some of the most DTC adver-
tised therapeutic classes immediately after the 1997 deregulation in the USA. We
conclude with an appraisal of the current state of affairs and directions for future
consideration and research.

22.2 DTCA Around the World: A Closer Look

at the Regulatory Environment

DTCA is strictly regulated worldwide and is banned by law in all but 2 of the 30
country members of the Organization for Economic Cooperation and Development
(OECD), USA and New Zealand. Although legislation is undeniably the major
determinant of DTCA status and form, the interpretation of the related clauses, the
efficiency of the regulatory bodies, their task performance, and the viewpoints of
other stakeholders influence considerably the practice of DTCA, rendering it a
highly complex issue (Peppin 2006 ).
New Zealand and the USA are the two most liberal countries regarding consumer-
directed pharmaceutical advertising. New Zealand has a self-regulatory system, the
Therapeutic Advertising Pre-vetting System (TAPS), managed through the
Association of New Zealand advertisers, which is responsible for the preclearance
of advertising messages. Unlike New Zealand, DTCA in the USA is centrally regu-
lated. The FDA reviews the ads based on the Food , Drug and Cosmetics Act (FDCA).
FDCA prohibits false and misleading claims which fail to present risk-benefit
information in a balanced manner and poses a series of requirements for DTCA
messages. First, drug companies are required to provide a “brief summary” of all
risk-related information such as contraindications, warnings, major precautions,
and non-serious adverse affects in a product's package labeling as well as in any
promotional material. Second, firms are required to send the ads they launch to
FDA, which then examines whether they comply with federal legislation. In 1997,
the FDA released a draft guidance allowing the drug companies to replace the “brief
summary” in TV broadcasts with major risks of the product in the audio or audio-
visual parts of the commercial, with the condition that they refer the viewers to
adequate sources of information such as a physician, a Web site, or a toll-free num-
ber where they can get more information. With this clarification guideline, DTCA
came to be seen as an attractive way of reaching patients, with total spending
amounting to a stable 40 % of the annual pharmaceutical promotional expenses
between 2005 and 2010 (IMS Health 2011 ).
FDA recognizes three types of DTCA based on the content of the promotional
message. Help - seeking advertisements contain information about the therapeutic cat-
egory, symptoms, conditions but do not mention any specific drug name or treatment
alternative. Thus, help-seeking messages can be considered as informative or “con-
structive” as they mainly raise awareness about a disease or condition. Reminder
advertisements contain the drug name only, and must by law refrain from presenting