Regulation of Labeling and
Promotion
Edward P. Richards
Harvey A. Peltier Professor of Law
Louisiana State University School of Law
richards@lsu.edu
http://biotech.law.lsu.edu
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Sources of Law
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Federal Trade Commission
FDA
State Deceptive Trade Practices Laws
State Tort Laws
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Legal Risks
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Drug Cannot Be Marketed
Drug Can Be Removed From The
Market
Civil Fines
Criminal Prosecution
Tort Judgments
Bankruptcy
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Why Is Labeling So
Important?
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All Drugs Pose Risks
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Inherent Risks
Risks Due To Interactions With Other Drugs
Risks Due To Disease States
Risk Of Over and Under Dosage
NO RISKS ARE OBVIOUS!
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Manufacturers Have The Most
Information
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Clinical Trials Under The IND
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Proprietary Information
Controlled By The Manufacturer
Should Be Reported To The FDA
Post-Market Information
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Manufacturer Gets Primary Reports
Should Pass Information To The FDA
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What is a Label - I
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"Brochures, booklets, mailing pieces, detailing
pieces, file cards, bulletins, calendars, price
lists, catalogs, house organs, letters, motion
picture films, film strips, lantern slides, sound
recordings, exhibits, literature, and reprints
and similar pieces of printed, audio or visual
matter descriptive of a drug and references
published (for example, the Physician's Desk
Reference)
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What is a Label - II
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for use by medical practitioners,
pharmacists, or nurses, containing drug
information supplied by the
manufacturer, packer, or distributor of
the drug and which are disseminated by
or on behalf of its manufacturer, packer,
or distributor are hereby determined to
be labeling as defined in section 201(m)
of the FD&C Act."
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Rx Drugs
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Physician Information
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Package Insert
Information Sheets For Physicians
Depends on Expertise of Physician
Rarely, Patient Package Insert
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When Patients Have Significant Control
Over Choice of Drugs
Birth Control Pills
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OTC
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On The Box
Insert In The Box
Must Allow Safe Use By Consumer
Labeling Issues Often Determine
Whether A Drug Is OTC or Rx
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Labels Can Make The Drug
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Apple Cider Vinegar Alone is not a Drug
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Apple Cider Vinegar with a Label that Says
It Will Cure Cancer is a Drug, Subject to
FDA Regulation
Also Subject to FTC Regulation
Does a Book Saying it Treats Cancer
Make it a Drug?
Is the Author Guilty of
Misrepresentation?
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Product Independent Labels
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Pamphlets And Flyers
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Are They Provided With The Drug Or To
Persons Who Buy The Drug?
Are They Necessary To Use The Drug?
Do They Undermine Or Conflict With The
FDA Approved Label?
What If The Pharmacy Provides Them
Independently of the Manufacturer?
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FDA Standards
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A Drug is Misbranded If:
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[Its] "labeling is false or misleading in any
particular" or
the labeling does not bear "adequate
directions for use."
Drugs are Misbranded if the
Manufacturer Does Not Use the FDA
Approved Label Information
Misbranded Products Cannot Be Sold
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Federal Trade Commission
Standards
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Misleading Or Deceptive
FTC Looks At All Advertising And Promotional
Materials
Penalties
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Civil Fines
Criminal Prosecution
Usually Secondary To The FDA For Drugs
Governs Medical Products That Are Not Under
the FDCA
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Tort Law Standards
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Must Provide Full Prescribing
Information
Must Provide All Side-effects and
Contraindications
Must Anticipate Misuse and Warn
Against it
Must Quickly Add Any New Information
about the Drug
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FDA Standard for an Rx Drug
Label
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Labeling must include the established
name, proprietary name (if any),
adequate directions for use, and
adequate warnings. The agency
considers the approved product
labeling, sometimes called the full
prescribing information, to be adequate
directions for use and adequate
warning.
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Are there exceptions to the
requirements for labeling?
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Reminder labeling, as defined in 21 CFR
201.100(f), is exempted.
Reminder labeling calls attention to the name
of the drug product but does not include
indications or dosage recommendations for
use. Reminder labeling may contain only the
proprietary name of the drug, the established
name of each active ingredient, and
optionally, information relating to quantitative
ingredient statements, dosage form, quantity
of package contents, price, and other limited
information.
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What the Label Cannot Have
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Unapproved Uses
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Only Uses From Approved NDAs
Hence "Off-Label" Uses
Disputes with the FDA
No Over-Warning
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CYA in Tort Cases
Interferes with Rational Prescribing
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Patient Package Inserts
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Legal Authority To Require?
Regulatory History
Why Did Physicians Oppose Them?
What Drugs Must Have Them Now?
Why Is The FDA Interested In Them
Again?
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Promotional Materials
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Real Issues
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Off Label Uses
Inappropriate Use
FDA Authority Over Promotional
Materials
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Can The FDA Control What Detailmen Say?
How Have Companies Gotten In Trouble?
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FDA Definition of Prescription
Drug Advertising
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21 CFR 202.1(l)1 states that advertisements subject
to Section 502(n) of the Food, Drug, and Cosmetic
Act (FD&C Act) include advertisements published in
journals, magazines, other periodicals, and
newspapers; and broadcast through media such as
radio, television, and telephone communications
systems. This is not a comprehensive list of
advertising media subject to regulation. For example,
FDA also regulates advertising conducted by sales
representatives, on computer programs, through fax
machines, or on electronic bulletin boards.
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What must a prescription drug
advertisement include?
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Under section 502(n) of the FD&C Act,
advertisements must include: the established
name, the brand name (if any), the formula
showing quantitatively each ingredient, and
information in brief summary which discusses
side effects, contraindications, and
effectiveness. The brief summary is further
discussed in 21 CFR 202.1(e)(1).
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Are there exceptions to the
advertising regulations?
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Yes, there are a few exceptions but only
to the requirement to provide a true
statement of information in brief
summary as required under 21 CFR
202.1(e)(1).
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21 CFR 202.1(e)(2) describes
which ads are exempt:
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Reminder advertisements
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advertisements which call attention to the name of the drug
product but do not include indications or dosage
recommendations for use of the product, or any other
representation. Reminder ads contain the proprietary name
of the drug and the established name of each active
ingredient. They may also contain additional limited
information, such as the name of the company, price, or
dosage form.
Advertisements of Bulk-sale drugs
Advertisements of prescription-compounding drugs
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promote sale of a drug for use as a prescription chemical or
other compound for use by registered pharmacists.
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Providing Information On
Unapproved Uses
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The Manufacturer Cannot Advertise
Unapproved Uses
The Manufacturer Can Send Out Medical
Journal Reprints On Unapproved Uses
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Must Log and Notify FDA
May Have to Retract if the Science Changes
Must A Manufacturer Warn Against Known
Unapproved Uses?
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Requirements for Direct to
Consumer Ads
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All the contraindications
All the warnings
All the major precautions
All other frequently occurring side
effects that are likely to be drug-related
Include Contact Phone and URL
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Internet Information
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WWW Pages are Subject To FDA
Regulation
Non-Manufacturer Sites
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Can Pharmacies Tout Unapproved Uses?
What about Access to Rx Drugs without an
Rx?
Can Manufacturers Link To NonManufacturer Sites?
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Tort Implications of Direct
Advertising
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Undermines Learned Intermediary
Defense
Can Trigger a Duty to Warn the Patients
Directly
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Makes Rx Drugs More Like OTC
Must the FDA Approve a Voluntary PPI?
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Future Issue
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Commercial Speech Restrictions On FDA
Authority
Blurring of OTC And RX Labeling
Because Of Internet Sales
Shifting Of Warning Duties To
Pharmicists
Changing Labeling Standards As States
License Non-Physician Prescribers
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