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(a) – Sec 202.1 is now repealed and replaced by Sec 202.3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.

 (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 1st, 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.

 (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.