This
website offers information on symposiums held during 2000 and 2001.
Listed below are overviews of symposium topics. Speaker information
is detailed in the "Symposium 2000" and "Symposium 2001" sections of this
website.
The topic
of the symposium held November 14, 2000 is: “Issues in Direct-to-Consumer
Pharmaceutical Advertising.” Please refer to specifics for the 2000
symposium below.
In the early
1980s, the first direct-to-consumer pharmaceutical advertisements appeared
in an effort to gain public acceptance of less expensive generic drugs.
In 1983, the FDA issued a moratorium on direct-to-consumer prescription
drug advertising. By 1985, the FDA had lifted the ban.
From 1985
to 1997, direct-to-consumer pharmaceutical advertisements were required
to provide extensive information about the products’ side effects, contraindications
and effectiveness. Print ads satisfied the requirement by reprinting the
package insert along with the advertisement. However, due to the nature
of the media, broadcast media could not adhere to the requirements. Television
and radio advertising had to use advertisements to either inform consumers
of the existence of a drug without specifying its purpose or educate consumers
about an illness without mentioning a drug.
In 1997,
the U.S. Food and Drug Administration relaxed the guidelines for direct-to-consumer
(DTC) pharmaceutical advertising. The advertisements, which can appear
in television, radio, newspapers, magazines, and the Internet, no longer
have to display
prescription information. Instead,
pharmaceutical companies must disclose “all major risks associated with
the drug.”
In addition
to the major risk-disclosing statement, the advertisement must contain
the following provisions:
-
A toll-free number for labeling to be
provided by mail, facsimile, or read over the phone
-
Reference to advertisements in consumer
magazines with a brief summary and brochures easily available in pharmacies
and doctors’ offices
-
A statement in the advertisement that
directs consumers to seek additional information from pharmacists
-
An Internet Web page address for access
to package labeling
Proponents
of DTC pharmaceutical advertising believe that the advertisements empower
consumers to take control of their own health. They feel that the advertisements
promote awareness of diseases and disease prevention. Critics of DTC pharmaceutical
advertising argue that information can be misleading and may not properly
warn consumers of side effects. In addition, the emergence of the Internet
further complicates the issue because of lack of regulation.
The 2001 symposium concerns issues related to pharmaceutical advertising.