Advertising Issues, Effectiveness Claims

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Advertising Issues, Effectiveness Claims. Mike Murphy DVM, JD, PhD Veterinary Medical Officer Division of Surveillance. Advertising Issues, Effectiveness Claims. Overview Review Scientific Foundation Examples Comments/Questions. Advertising Issues, Effectiveness Claims. Review - PowerPoint PPT Presentation

Text of Advertising Issues, Effectiveness Claims

Advertising Issues, Effectiveness Claims

1AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 Mike Murphy DVM, JD, PhDVeterinary Medical OfficerDivision of SurveillanceAdvertising Issues, Effectiveness Claims

12AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 Overview

ReviewScientific FoundationExamplesComments/Questions

Advertising Issues, Effectiveness Claims

23AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 Review

True and not-misleadingNew Use/Extra-Label Use

Advertising Issues, Effectiveness Claims

34AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 Review

True and not-misleading

Advertising Issues, Effectiveness Claims

45AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 Authority

ConstitutionCase lawStatuteRegulations

Advertising Issues, Effectiveness Claims

56AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 First AmendmentCongress shall make no law abridging the freedom of speech, .Exceptions regulation of commercial speech

Advertising Issues, Effectiveness Claims

67AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 Authority

ConstitutionCase lawStatuteRegulations

Advertising Issues, Effectiveness Claims

78AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 Case LawCENTRAL HUDSON GAS & ELECTRIC CORP. v. PUBLIC SERVICE COMMISSION OF NEW YORK447 U.S. 557; 100 S. Ct. 2343; 65 L. Ed. 2d 341

In commercial speech cases, a four-part analysis has developed.

(1)At the outset, a court must determine whether the expression is protected by U.S. Const. amend. I.

For commercial speech to come within that provision, it at least must concern lawful activity and not be misleading.

Advertising Issues, Effectiveness Claims

89AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 Authority

ConstitutionCase lawStatuteRegulations

Advertising Issues, Effectiveness Claims

910AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 21 U.S.C. 352 TITLE 21--FOOD AND DRUGS CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V--DRUGS AND DEVICES Part A--Drugs and Devices

Sec. 352. Misbranded drugs and devices A drug or device shall be deemed to be misbranded

(n) Prescription drug advertisements: established name; quantitative formula; side effects, contraindications, and effectiveness; prior approval; false advertising; labeling; construction of the Convention on Psychotropic Substances

Advertising Issues, Effectiveness Claims

1011AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 21 U.S.C. 352 TITLE 21--FOOD AND DRUGS CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V--DRUGS AND DEVICES Part A--Drugs and Devices

Sec. 352. Misbranded drugs and devices A drug or device shall be deemed to be misbranded--(n) Prescription drug advertisements: established name; quantitative formula; side effects, contraindications, and effectiveness; prior approval; false advertising; labeling; construction of the Convention on Psychotropic Substances

In the case of any prescription drug distributed or offered for sale in any State, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug a true statement of (3) such other information in brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations which shall be issued by the Secretary in accordance with the procedure specified in section 371(e) of this title,

Advertising Issues, Effectiveness Claims

1112AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 Authority

ConstitutionCase LawStatuteRegulations

Advertising Issues, Effectiveness Claims

1213AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 regulations which shall be issued by the Secretary

21 C.F.R. 202.1 Prescription Drug Advertising

Advertising Issues, Effectiveness Claims

1314AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 21 CFR 202.1(e) True statement in brief summary

6.Advertisements that are false, lacking in fair balance, or otherwise misleading.

An advertisement for a prescription drug is false, lacking in fair balance, or otherwise misleading, or otherwise violative of section 502(n) of the act, among other reasons, if it:

through (xx)

20 paragraphs identifying what is false or otherwise misleading follow in 21 CFR 202.1(e)(6).

Advertising Issues, Effectiveness Claims

1415AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 Review

New Use/Extra Label Use

Advertising Issues, Effectiveness Claims

1516AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 Authority

ConstitutionCase lawStatuteRegulations

Advertising Issues, Effectiveness Claims

1617AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 AuthorityRegulations

21 CFR 51421 CFR 530

Advertising Issues, Effectiveness Claims

1718AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 21 CFR 514.100 (d)Evaluation and comment on applicationFor prescription new animal drugs:

(d) The information contained in an application may be insufficient

(2) The application fails to show that the labeling and advertising of such drug will offer the drug for use only under those conditions for which it is offered in the labeling that is part of the application.

Advertising Issues, Effectiveness Claims

1819AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 21 CFR 514.8(c ) (2)

Labeling changes requiring the submission and approval of a supplement prior to distribution of the drug made using the change (major changes).

Advertising Issues, Effectiveness Claims

1920AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 21 CFR 514.8(c ) (2)

Labeling changes requiring the submission and approval of a supplement prior to distribution of the drug made using the change (major changes).

(A) Revisions in labeling such as updating information pertaining to effects

Advertising Issues, Effectiveness Claims

2021AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 21 CFR 514.8(c ) (2)

Labeling changes requiring the submission and approval of a supplement prior to distribution of the drug made using the change (major changes).

(B) Addition of an intended use;

Advertising Issues, Effectiveness Claims

2122AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 21 CFR 514.8(c ) (2)

Labeling changes requiring the submission and approval of a supplement prior to distribution of the drug made using the change (major changes).

(C ) It is a prescription drug, any mailing or promotional piece used after the drug is placed on the market is labeling requiring a supplemental application, unless

Advertising Issues, Effectiveness Claims

2223AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 21 CFR 530.4Advertising and Promotion(Extra-label Drug Use)

Nothing in this part shall be construed as permitting the advertising or promotion of extralabel uses in animals of approved new animal drugs or approved human drugs.

Advertising Issues, Effectiveness Claims

2324AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 21 CFR 530.3Definitions(a) Extralabel use means actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling.

Advertising Issues, Effectiveness Claims

2425AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 21 CFR 530.3Definitions This includes, but is not limited to: use in a species that is not listed in the labeling, use for indications (diseases of other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses.

Advertising Issues, Effectiveness Claims

2526AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 Review

True and Not-misleadingNew Use/Extralabel Use

Advertising Issues, Effectiveness Claims

2627AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 Overview

ReviewScientific FoundationExamplesComments/Questions

Advertising Issues, Effectiveness Claims

2728AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 What is the scientific foundation for true and non-misleading commercial speech promoting the effectiveness of new animal drugsthat does not promote a new use or extralabel use of the drug ?

Advertising Issues, Effectiveness Claims

2829AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 What is the scientific foundation for true and non-misleading commercial speech promoting the effectiveness of new animal drugsthat does not promote a new use or extralabel use of the drug ?

Substantial evidenceSee 21 CFR 514.4

Advertising Issues, Effectiveness Claims

2930AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 Where do we look forSubstantial evidence ?

Advertising Issues, Effectiveness Claims

3031AAVPT Veterinary Drug Regulatory Cycle (A to Z)3 March 2011 Where do we look forSubstantial evidence ?

LabelingFOI SummarySpon