Interplay Between FDA Advertising and Promotion Enforcement Activities, Product Liability, and Consumer Fraud Litigation

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1 Interplay Between FDA Advertising and Promotion Enforcement Activities, Product Liability, and Consumer Fraud Litigation Leslie M. Tector Quarles & Brady LLP September 30, 2014

2 Objectives Which federal governmental agencies oversee enforcement of the advertising and promotion of drugs, biologics and devices? What are the general requirements of those agencies related to advertising and promotion? How are violations of advertising and promotion legal requirements resulting in consumer fraud, false claims and product liability claims against manufacturers? 2

3 Regulations and Regulators The U.S. Food Drug & Cosmetic Act of 1938 ( FDCA ) Manufacture, marketing, sale, and distribution of drugs, biologics and medical devices and enforcement is primarily a function of U.S. Food and Drug Administration ( FDA ) and U.S. Department of Justice. The Federal Trade Commission ( FTC ) and the FDA have overlapping statutory authority relating to advertising; since 1954, they have operated under a Memorandum of Understanding. The FTC has primary authority for advertising of foods, dietary supplements, and OTC drugs and non-restricted devices under the Federal Trade Commission Act of The FDA has primary authority for labeling of products and for advertising of prescription drugs and restricted devices 3

4 What are we talking about? Common methods of Advertising and Promotion detail aids convention displays, other materials used by sales representatives advertisements in medical journals, internet and elsewhere to target prescribing physicians, other prescribers, or patients directly oral statements made by manufacturer s personnel in doctors offices, medical conventions and else where, as well as promotion talks given by outside physicians on behalf of a manufacturer 4

5 What s the big deal? FDA Enforcement: Untitled letters Warning letters Injunctions Seizures Civil and criminal fines Imprisonment Withdrawal of product approval Violations of other statutes and enforcement by other agencies 5

6 Labels and Labeling Label means a display of written, printed or graphic matter upon the immediate container of any article. 21 U.S.C. 321(k). Labeling means all labels and other written, printed, graphic matter (1) upon any article or any of its containers or wrappers; or (2) accompanying such articles. 21 U.S.C. 321(m). FDA-approved patient labeling FDA-approved product labeling 6

7 Label and Labeling-continued Accompanying does not mean that the material must be physically connected to the product. The connection can be textual. The test is whether the material supplements or explains the drug. Kordel v. United States, 335 U.S. 345 (1948). Off label-use means the use of an FDA-approved or cleared product, in a manner that has not been approved by or cleared by the FDA. This means that the use is not within the scope of the indication of use or uses that was approved or cleared by the FDA. 7

8 Labeling Requirements/ Misbranding FDCA sets forth 23 labeling requirements for drugs, biologics and devices. Failure to meet any of those requirements results in a drug, biologic or device being misbranded. Misbranding also occurs if the labeling is false or misleading in any particular 21 USC 352(a); or does not include adequate direction for use 21 USC 352(f). FDCA makes it a crime to introduce a drug, biologic or device into interstate commerce if the product is misbranded. 8

9 Advertising and Promotion- Same thing? Advertising examples include: advertisements in published journals, magazines, other periodicals and newspapers, as well as broadcasting advertisements in media such as radio, television and telephone communications and are subject to the misbranding provisions of the FDCA See 21 CFR 202.1(l)(1). Promotion refers to both labeling and advertising collectively and is a term used in FDA guidance. Differentiation: advertising is Who is producing and selling that product, for what reason and at what price? Virginia State Board v. Virginia Citizens Council, 425 U.S. 748, 765 (1976). Promotional materials are generally given to prescribers or consumers directly. 9

10 Requirements for Print and Broadcast Advertisements Brief Summary is required for printed materials. Exceptions: reminder advertisements, and coming soon, except for drug with Black Box warnings. Major Statement is required for Broadcast. Must disclose products major risk, and make adequate provision for viewers to access product labeling. 10

11 Basic Types of Advertisements Product Claim Advertisements Product name and use Reminder Advertisements Product name, sponsor name, but not indication or recommended dosage Help-Seeking Advertisements Discuss disease condition and see your doctor 11

12 Does the FDA approve advertisements and promotions? Advertising and Promotion Material are generally not preapproved by the FDA but submitted at time of first use Exceptions: launch materials; accelerated approval; and FDA special requirements. FDA relies on after-the-use enforcement to address violations 12

13 FDA Review Standards for Advertising and Promotion of Rx Drugs, Restricted Devices & Biologics Under the FDCA, the advertising and promotional material must Be prominently displayed Provide adequate Directions for Use Contain a True Statement Not be false or misleading Be a fair balance of benefits and risks Provide other product specific information 13

14 FTC Review Standard for Advertising and Promotion of OTC Drugs and Non-Restricted Medical Devices Section 5 of the Federal Trade Commission Act gives the Commission broad authority to prohibit "unfair or deceptive acts or practices under the auspices of consumer protection. Sections 12 through 15 of the Act prohibit the dissemination of misleading claims for food, drugs, devices, services and cosmetics. Covers almost all products and product related services. FTC s prior approval of advertising materials is not required. For health and safety claims FTC requires the competent and reliable scientific evidence. 14

15 When is an Advertisement Deceptive? An advertisement is deceptive if it: Contains a misrepresentation or omission; and Is likely to mislead consumers acting reasonably under the circumstances to their detriment. Claims must be material to consumer s decisions to buy or use the product. FTC is not required to prove actual injury. 15

16 What Constitutes an Unfair Practice? An advertisement or trade practice is unfair if it: Causes or is likely to cause substantial consumer injury; Is not reasonably avoidable by consumers themselves; and Is not out weighed by countervailing benefits to consumers or competition. 16

17 FTC Enforcement Cease and desist orders. Civil penalties but may have criminal penalties. Corrective advertisements. 17

18 Regulation of Off-Label Use 18

19 Limitations of Marketing and Promotion of Off-Label Communications FDCA approves products for marketing after sufficient evidence that it is safe and effective for intended uses. New drugs that are not generally recognized as safe and effective for the condition set forth in the labeling are deemed unapproved and cannot be sold. Limited regulatory ban related to advertisements that recommend or suggest off-label use. 21 C.F.R. sec (e)(4). 19

20 Limitations of Marketing and Promotion of Off-Label Communications FDA does not regulate: Practice of Medicine Exchange of Scientific Information Response to unsolicited requests from physicians Continuing medical education programs Peer-reviewed scientific and medical journals 20

21 Other Legal Claims Related to Off-Label Use 21

22 Other Legal Claims Related to Off-label Use False Claims allegations Under The False Claims Act (21 U.S.C et. seq) civil monetary penalty and criminal liability imposed against anyone who defrauds the federal government by submitting a false claim Qui tam relators entitled to between % of the recovered amount civil penalty of between $5,000 and $11,000 for each false claim and treble the amount of the government s damages Example: Neurontin Case (2004)- $430 million total / $240 million criminal fine, 2 felony violations, Corporate Integrity Agreement with unprecedented oversight over off-label promotion 22

23 Other Legal Claims Related to Off-label Use Products Liability e.g., Coleman v. Medtronic Device manufacturer sued over off-label use of spinal device. Plaintiff brought state law product liability claims related to failure to warn, negligence, and defective manufacturing. Device Manufacturer raised issues of state law preemption. 23

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