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U.S. Regulation of Prescription Drug Marketing and Promotion October 21, 2004 Bill Ross.

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Presentation on theme: "U.S. Regulation of Prescription Drug Marketing and Promotion October 21, 2004 Bill Ross."— Presentation transcript:

1 U.S. Regulation of Prescription Drug Marketing and Promotion October 21, 2004 Bill Ross

2 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 2 Objectives Review key U.S. federal regulations on prescription drug marketing and promotion Examine general requirements for drug advertising and promotion Understand policies and guidelines for scientific and medical education programs

3 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 3 U.S. federal regulations on prescription drug marketing and promotion

4 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 4 History of Drug Regulation Vaccine Act of 1813 –First federal government program designed to improve the health and well-being of the general populace –Statute enacted to ensure adequate amounts of vaccine was available –Repealed when small pox vaccine was attributed with spreading smallpox

5 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 5 History of Drug Regulation Drug Importation Act of 1848 –Ban on importation of adulterated and spurious drugs –Law required all drugs entering the U.S. through its six major ports to be analyzed for "quality, purity, and fitness for medical purposes"

6 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 6 History of Drug Regulation Biologics Control Act of 1902 –Statute enacted after tetanus-infected diptheria antitoxin was distributed –The production of biologics requires a licensing process –Licensed establishments were inspected by scientists and medical officers from the National Hygienic Laboratory, the forerunner of the present National Institutes of Health (NIH).

7 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 7 History of Drug Regulation The Great American Fraud Articles of 1905 by Samuel Hopkins Adams –Exposes the fraud of the patent medicine business –Hard-hitting full scale exposure of medical quackery –Congress enacts the first of several pure food and drug laws in 1906

8 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 8 History of Drug Regulation Federal Food & Drugs Act of 1906 –USDA, Bureau of Chemistry –Law prohibiting interstate commerce in adulterated and misbranded drugs Criminal penalties Seizure of offending products –Purity standards established by U.S. Pharmacopoeia and National Formulary –Required narcotics be disclosed on products labeling –Forbid imitations

9 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 9 History of Drug Regulation Sherley Amendments of 1912 –Statute prohibiting labeling medicines with false therapeutic claims intended to defraud the purchaser –Difficult to prove

10 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 10 History of Drug Regulation Harrison Act of 1914 –All opium and coca products require strict accounting –Upper limits on the amount of opium, opium- derived products, and cocaine allowed in products available to the public –Taxation

11 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 11 History of Drug Regulation Food and Drug Administration formed in 1931

12 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 12 History of Drug Regulation Federal Food, Drug and Cosmetic Act of 1938 –Elixir sulfanilamide disaster of 1937 (107 dead) –Penalties for adulteration and misbranding without proof of fraud (eliminating need for Sherley act) –Authorized NDAs Required new drugs to be shown safe before marketing –Dangerous drugs must be administered under the direction of a qualified expert Established prescription only (non-narcotic) drugs Permitted manufacturers to determine if their drug was a prescription FDA could sue the manufacturer if it disagreed with the decision

13 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 13 History of Drug Regulation Federal Trade Commission Act Amendments of 1938 –Gave FTC authority to regulate drug advertising

14 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 14 History of Drug Regulation Kefauver Amendments to Food, Drug and Cosmetics Act (1962) –Response to thalidomide tragedy –Drug manufacturers are required to provide to FDA substantial evidence of efficacy and safety of their products before marketing them –FDA gains authority to regulate Rx promotion and clinical testing –Manufacturers must demonstrate the efficacy of products approved prior to 1962

15 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 15 History of Drug Regulation FDA requires the first patient package insert: oral contraceptives must contain information for the patient about specific risks and benefits (1972) Orphan Drug Act passed, enabling FDA to promote research and marketing of drugs needed for treating rare diseases (1983) Prescription Drug Marketing Act of 1987 –Bans the diversion of prescription drugs from legitimate commercial channels –Prohibited reimportation of drugs by anyone other than the manufacturer –Bans sale, trade or purchase of drug samples

16 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 16 History of Drug Regulation FDAMA: Food and Drug Modernization Act of 1997 –PDUFA--Prescription Drug User Fee Act –Pediatric studies –Healthcare economics information –Restricted dissemination of off-label uses* –FDA approved –Established a registry of clinical trials for both federally and privately funded trials of experimental treatments for serious or life-threatening diseases * See Washington Legal Foundation (WLF) vs. FDA 1994

17 General requirements for drug advertising and promotion

18 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 18 Labeling All written matter accompanying a drug FDA determines whether the labeling of drugs is false or misleading Must be accompanied by full prescribing information

19 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 19 Labeling PI –Prescribing information –Package insert –Product information –Detailed prescribing information PPI –Patient package insert –Patient product information Brief Summary –Brief summary of prescribing information

20 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 20 Content and Format of PI Description Clinical pharmacology Indications and usage Contraindications Warnings Precautions Adverse reactions Overdosage Dosage and administration How supplied References

21 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 21 Content and Format of Patient Information How to pronounce it What is it? How does it work? How should I take it? Who should not take it? What other medical conditions should I discuss with my doctor? What are the possible side effects? Can it be take with other medications? What should I know about the disease? How should I store it? General information (e.g., keep away from children, overdose, etc.)

22 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 22 Advertising and Promotion [Code of Federal Regulations] [Title 21, Volume 4] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR202.1] [Page 72-81] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 202--PRESCRIPTION DRUG ADVERTISING--Table of Contents Sec Prescription-drug advertisements: (a)(1) The ingredient information required by section 502(n) of the Federal Food, Drug, and Cosmetic Act shall appear together, without any Intervening written, printed, or graphic matter, except the proprietary names of ingredients, which may be included with the listing of established names. (2) The order of listing of ingredients in the advertisement shall be the same as the order of listing of ingredients on the label of the product, and the information presented in the advertisement concerning the quantity of each such ingredient shall be the same as the corresponding information on the label of the product. (3) The advertisement shall not employ a fanciful proprietary name for the drug or any ingredient in such a manner as to imply that the drug or ingredient has some unique effectiveness or composition, when, in fact, the drug or ingredient is a common substance, the limitations of which are readily recognized when the drug or ingredient is listed by its established name. (4) The advertisement shall not feature inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation. Office of Medical Policy Division of Drug Marketing, Advertising, and Communications Laws, Regulations, Guidances, and Enforcement Actions

23 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 23 Advertising and Promotion Musts –Accompanied by a brief summary adjacent to ad –Cant be false or misleading –Provide adequate directions for use –Contain true statement of safety and effectiveness –Include fair balance –Include all material facts –Consistent not contrary to labeling Must not –Be False, Misleading, or Lacking in Fair Balance 21 C.F.R –Failure to do all of the above Musts is in violation of this statute

24 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 24 Advertising and Promotion Unsubstantiated claims include: –Statements suggesting the drug is better than it in fact is Failure to disclose clinical claims which may be due to concomitant therapy or placebo effect –Claims not studied in a population Claims based on data from healthy subjects –Clinical statements that are not current –Clinical statements that are not representative of the study population –Claims based on retrospective analysis –Use of information from an inadequate study –Mechanism of action claims not established

25 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 25 Advertising and Promotion False, Misleading or Lacking Fair Balance –Uses tables or graphs to distort or misrepresent the relationships, trends, differences, or changes among the variables or products –Failure to include balance (talking about a drugs efficacy w/o discussing SEs, contraindications, etc.) on each spread with a prominence and readability reasonably comparable with the presentation of information relating to effectiveness of the drug…

26 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 26 Enforcement Issues Broad Issues –Omission/minimization of risks –Promotion of unapproved uses –Unsubstantiated claims Efficacy –Outcomes –Survival Safety Comparative

27 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 27 Enforcement Scope Journal Ads Sales aids/detailers Giveaways Sales representatives Commercial exhibit halls DTC broadcast ads DTC print ads Websites

28 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 28 Warning Letters Lack of important risk information Minimization of important safety information Misleading comparative claims Overbroadening of the indication Omission from body of ad –crucial facts related to potential risks –potential for abuse –limitations on appropriate indicated use Unsupported outcomes claims

29 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 29 OxyContin Warning Letter Journal advertisements Lack of important risk information Overbroadening of the indication Omission from body of ad –crucial facts related to potentially fatal risk –potential for abuse –limitations on appropriate indicated use

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34 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 34 Claims Claim –Often considered an indication –Non-comparative Improvement –Scientific evidence of diminution of the signs and symptoms of a condition New –Only for the first six months of US market introduction Safe –Prescription drugs are inherently unsafe –Use tolerability or safety profile

35 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 35 Comparative Claims Comparative claim –Conveys comparability, superiority –May be done to support a change in promotion of a product Must be consistent with labeling Statistically significant –Misleading use of statistics is misbranding of a drug –Must indicate level of statistical significance with P value. –Usually 0.05 Clinically significant –True statements without clinical significance can be misleading Presented with fair balance

36 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 36 Comparative Claims Cannot be based on: –Partial information –Selected facts of the underlying study –In vitro evidence –Computer modeling –Blood levels or tissue levels –Anecdotal evidence –Label comparisons

37 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 37 Comparative Claims Substantiation –Generally requires two adequate and well-controlled studies –Reasons for two studies Any clinical study may be subject to undetected, systematic bias The inherent variability in biological systems may produce a positive result purely by chance Results obtained from a single site may be investigator specific Possibility of fraud

38 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 38 Comparative Claims Adequate and well-controlled –Clear statementof objectives –Valid comparison to a control –Randomized –Blinded –Pre-specified endpoints Consistent with and not contrary to approved labeling –Approved for indication studied –Dosage regimens must be appropriate for comparison –Dosages must be consistent with approved labeling

39 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 39 Comparative Claims Situations where a single study may suffice –Trial demonstrating meaningful effect on morbidity, mortality or prevention of a serious disease AND –Confirmation of the result in a second trial would be unethical AND –Must be consistent with all available evidence

40 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 40 Comparative Claims Types of comparative claims –Superiority Indicates that a product is superior to a therapeutic alternative Must be demonstrated on all relevant factors Implies product should be administered preferentially in most cases –Price comparisons –Preference claims –Most prescribed claims –More potent claims –Drug of choice claims –Comparisons to generics: cannot suggest any therapeutic or quality difference between a branded and generic product –First line –Statements about other drugs: can be misleading

41 Policies and guidelines for scientific and medical education programs

42 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 42 Medical Education CME (Continuing Medical Education) –Educational activities which are not promotional in nature may be sponsored by industry and not subject to regulation by the FDA –FDA closely scrutinizes educational programs to insure they are truly independent educational/scientific discourse, and not just disguised promotion

43 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 43 Medical Education FDA criteria for determining whether MedEd programs are truly educational –Written agreement between provider of the activity and sponsoring company that the provider is not influenced by the sponsoring company –Provider has full control over the program content including selection of speakers and moderators –Any financial relationship between providers, speakers and company sponsor must be disclosed –Sponsoring company cannot dictate content of program –No ancillary promotional activities are permitted by the company in the same location area as the program –Data presented must be objective and balanced –There should be disclosure on limitations of data presented –Provider and/or speaker should disclose any unapproved indications –There should be opportunity for debate –Invited guests cannot be targeted by marketing to discuss marketing of the product –The speaker should not focus on one companys product or show bias –Repeat performances of the same seminars can be deemed promotional`

44 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 44 Medical Education A company may pay for meals, travel and lodging for speakers. However, extravagant gifts beyond the speakers costs are considered promotional. AMA guidelines –No gifts if there are reciprocities –Physician gifts should be no more than $100 in value. No cash payments –Gifts should be medically relevant (related to a physicians work) –Subsidies to underwrite educational program costs should be made to provider and not to physicians in attendance –Subsidies cannot be made for travel, lodging or other personal expenses to physicians attending a MedEd conference unless it is for faculty at the conference. Only hospitality gestures such as a meal can be made by a company to physicians at a conference.

45 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion 45 Three Words


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