prohibition of direct to consumer advertising
TRANSCRIPT
8/9/2019 Prohibition of Direct to Consumer Advertising
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Title 21 – Food and Drugs
Chapter I – Food and Drug Administration - Department of Health and Human Services
Subchapter C – Drugs: General
Part 202 – Prescription Drug Advertising
Sec 202.1 – Prescription Drug Advertisements
(a) – Sec 202.1 is now repealed and replaced by Sec 202.3
Sec 202.2 – Definitions
(a) For the purposes of this section, prescription drug is defined as a finished
dosage form, e.g., tablet, capsule, or solution that contains an active drug
ingredient and is only available through a prescription written by a duly licensed
provider and dispensed in accordance with federal and state pharmacy practice
laws. For purposes of this section, prescription drug also means biological product
within the meaning of section 351(a) of the Public Health Service Act.
(b) For the purposes of this section, Direct to Consumer Advertising is defined as
providing material in the form of written, audio, or visual advertisements in
newspapers, magazines, general consumer publications, television, or websites
that promote a prescription drug, as defined above, with the intent to influence
consumers or healthcare providers to seek treatment with a prescription drug.
(c) For the purposes of this section, pharmaceutical sales representative is
defined as a professional employee of a drug application holder who educates
and informs healthcare professionals about prescription drugs including, but not
limited to, approved and unapproved uses, important safety information, clinical
trial data, and recommended doses.
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(d) For the purposes of this section, drug application holder is defined as a
pharmaceutical company who holds the marketing application (New Drug
Application) for a prescription drug.(does this include generic drug
manufacturers?)
(e) For the purposes of this section, prescription drug sample is defined as a unit
of a prescription drug that is not intended to be sold and is intended to promote
the sale of the drug (21CFR203.3i).
Sec 202.3 – Prohibition of Direct to Consumer Advertising for Prescription Drugs
(a) Effective January 1
st
, 2010, sec 202.3 replaces Sec 202.1 of 21CFR202.
(b) Drug application holders may no longer pursue or engage in Direct to
Consumer Advertising of prescription drugs.
(c) Drug application holders’ pharmaceutical sales representatives can continue to
engage, interact with, and educate healthcare providers about prescription drugs
as long as they provide a fair and balanced profile for the prescription drug to
include:
(1) Full disclosure of the approved and unapproved uses for the
prescription drug and any supporting or detracting clinical trial data for
these uses.,
(2) Full disclosure of the safety profile of the drug, including information
on placebo controlled studies and similar competitor comparator drug
safety profiles.For the purposes of this section, full disclosure is to include,
but is not limited to, all known or observed side effects, prevalence of side
effects, and known contraindications.
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(3) Full disclosure of financial interests of all individual research scientists
or research groups included in or in the conduct of clinical trial studies or in
the writing of journal articles based on said studies.
(d) Pharmaceutical sales representatives may no longer distribute prescription
drug samples as part of their interaction with healthcare providers, as this is
considered of a form of Direct to Consumer Advertising.
(e) Sec 202.3 will be fully enacted on January 1st 2010, drug application holders
failing to meet the requirements of Sec 202.3 will be in violation of this
regulation.