Principles and Practice of Pharmaceutical Medicine

51.7 Regulations regarding

marketing of prescription

drugs

The United States and Canada

TheFoodandDrugAdministration(FDA)hasregu-
lated advertising of prescription drugs in the United
States since 1962 under the Federal Food, Drug and
Cosmetic Act and related regulations. Advertising
for other products, including over-the-counter
(OTC) products, is controlled by the Federal
Trade Commission under different rules. It is the
FDA’sDivisionofDrugMarketing,Advertisingand
Communications (DDMAC) which enforces these
regulations and oversees promotional labeling and
advertising of prescription drugs (Rados, 2004).
In the United States, direct-to-consumer (DTC)
advertising of prescription drugs by brand name is
permitted,butcontrolledbyregulationstomakesure
that all information is accurate, balanced, with
details of possible side effects as well as statements
of benefits that could be expected. Details of how to
access more detailed information must also be
provided (US Department of Health and Human
Services, 1999). The recent withdrawal for safety
reasons of rofecoxib, which had been heavily
promoted using DTC advertising in the United
States, will probably increase scrutiny of this prac-
ticebythosewhoregulateit.Meanwhile,Canadahas
banned DTC advertising of prescription drugs since
1949; nonetheless, most Canadians live quite close
to the US border, and can view US television and
radio advertisements (Palumbo and Mullins, 2002).

The United Kingdom and Europe

Medicines cannot be promoted in the United
Kingdom until they have been granted marketing
authorization from the UK Medicines Control
Agency or the European Medicines Evaluation
Agency. There are three categories of licensed
medicines available in the United Kingdom:
prescription-only (POM), pharmacy sale (P) and
general sales medicines (GSL). The position of a
medicine in one of these categories is on the deci-
sion of the Health Ministers on the advice of the

Medicines Control Agency, the Committee on the

Safety of Medicines and the Medicines Commis-

sion, based on the product’s possible use, any side

effects and risk of its misuse. POMs and certain

pharmacy sales medicines must not be promoted to

the general public, but can be marketed to the

medical profession. The Association of the British

Pharmaceutical Industry (ABPI) Code of Practice

regulates promotional activities (Association of the

British Pharmaceutical Industry, 2001).

DTC advertising is prohibited within the EU, but

is seen as inevitable to some extent anyway due to

international access to the Internet and digital tele-

vision (‘t Hoen, 2003). This prohibition is to the

extent that medical journals bearing drug adver-

tisements on their covers cannot be mailed in see-

through bags unless such advertisements are

obscured with additional pieces of paper inside

the wrapper.

International patent laws

Patent laws have recently been updated internation-

allyviathe World Trade Organization’s Trade-

Related Aspects of Intellectual Property Rights

(TRIPS) Agreement. Adopted in 2001, this sets

out minimal standards for the protection of intellec-

tual property rights, which now lasts for at least 20

years from filing. The problem of developing coun-

tries being unable to afford necessary drugs, espe-

cially for HIV/AIDS, was addressed by the clause

allowing countries to make or import generic ver-

sions of drugs under compulsory licensing, where

the country’s own pharmaceutical industry is

allowed to manufacture generic versions of essen-

tial drugs still protected by patent, or parallel trade,

where branded drugs made more cheaply in other

countriesareimportedatlowercost(‘tHoen,2003).

51.8 Marketing budgets

IntheUnitedStatesin1998,thepharmaceuticalind-

ustry spent $12 724 million on promotion. Of this

86% was spent on the top 250 drugs,

52% was spent on the top 50 drugs,

656 CH51 ADVERTISING AND MARKETING