Regulation of Labeling and Promotion

Edward P. RichardsHarvey A. Peltier Professor of Law

Louisiana State University School of Lawrichards@lsu.edu

http://biotech.law.lsu.eduClick Here For Updated Slides

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Sources of Law

Federal Trade Commission FDA State Deceptive Trade Practices

Laws State Tort Laws

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Legal Risks

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?

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!

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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

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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)

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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."

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Rx Drugs Physician Information

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

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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

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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?

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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?

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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

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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

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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

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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.

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Are there exceptions to the requirements for labeling? 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

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

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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?

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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?

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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.

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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).

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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).

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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.

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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?

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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

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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?

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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?

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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