1. Regulation of Labeling and Promotion
Edward P. Richards Harvey A. Peltier Professor of Law Louisiana State University School of Law
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2. Sources of Law Federal Trade Commission FDA
State Deceptive Trade Practices Laws
State Tort Laws

3. Legal Risks Drug Cannot Be Marketed
Drug Can Be Removed From The Market
Civil Fines
Criminal Prosecution
Tort Judgments
Bankruptcy

4. Why Is Labeling So Important?
All Drugs Pose Risks
Inherent Risks
Risks Due To Interactions With Other Drugs
Risks Due To Disease States
Risk Of Over and Under Dosage
NO RISKS ARE OBVIOUS!

5. Manufacturers Have The Most Information
Clinical Trials Under The IND
Proprietary Information
Controlled By The Manufacturer
Should Be Reported To The FDA
Post-Market Information
Manufacturer Gets Primary Reports
Should Pass Information To The FDA

6. What is a Label - I
"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)

7. What is a Label - II
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."

8. Rx Drugs Physician Information Depends on Expertise of Physician
Package Insert
Information Sheets For Physicians
Depends on Expertise of Physician
Rarely, Patient Package Insert
When Patients Have Significant Control Over Choice of Drugs
Birth Control Pills

9. OTC On The Box Insert In The Box Must Allow Safe Use By Consumer
Labeling Issues Often Determine Whether A Drug Is OTC or Rx

10. Labels Can Make The Drug
Apple Cider Vinegar Alone is not a Drug
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?

11. Product Independent Labels
Pamphlets And Flyers
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?

12. FDA Standards A Drug is Misbranded If:
[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

13. Federal Trade Commission Standards
Misleading Or Deceptive
FTC Looks At All Advertising And Promotional Materials
Penalties
Civil Fines
Criminal Prosecution
Usually Secondary To The FDA For Drugs
Governs Medical Products That Are Not Under the FDCA

14. Tort Law Standards 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

15. FDA Standard for an Rx Drug Label
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.

16. Are there exceptions to the requirements for labeling?
Reminder labeling, as defined in 21 CFR (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.

17. What the Label Cannot Have
Unapproved Uses
Only Uses From Approved NDAs
Hence "Off-Label" Uses
Disputes with the FDA
No Over-Warning
CYA in Tort Cases
Interferes with Rational Prescribing

18. Patient Package Inserts
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?

19. Promotional Materials
Real Issues
Off Label Uses
Inappropriate Use
FDA Authority Over Promotional Materials
Can The FDA Control What Detailmen Say?
How Have Companies Gotten In Trouble?

20. FDA Definition of Prescription Drug Advertising
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.

21. What must a prescription drug advertisement include?
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).

22. Are there exceptions to the advertising regulations?
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).

23. 21 CFR 202.1(e)(2) describes which ads are exempt:
Reminder advertisements
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
promote sale of a drug for use as a prescription chemical or other compound for use by registered pharmacists.

24. Providing Information On Unapproved Uses
The Manufacturer Cannot Advertise Unapproved Uses
The Manufacturer Can Send Out Medical Journal Reprints On Unapproved Uses
Must Log and Notify FDA
May Have to Retract if the Science Changes
Must A Manufacturer Warn Against Known Unapproved Uses?

25. Requirements for Direct to Consumer Ads
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

26. Internet Information WWW Pages are Subject To FDA Regulation
Non-Manufacturer Sites
Can Pharmacies Tout Unapproved Uses?
What about Access to Rx Drugs without an Rx?
Can Manufacturers Link To Non-Manufacturer Sites?

27. Tort Implications of Direct Advertising
Undermines Learned Intermediary Defense
Can Trigger a Duty to Warn the Patients Directly
Makes Rx Drugs More Like OTC
Must the FDA Approve a Voluntary PPI?

28. Future Issue 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