The Role of OPDP in Regulating Prescription Drug Promotion Prescription Drug Promotion Richard Lyght Pharm D Richard Lyght, Pharm .D. Regulatory Review Officer Food and Drug Adm inistration ood a d ug d st at o Office of Prescription Drug Prom otion Division of Consum er Drug Prom otion
OBJECTIVES OBJECTIVES � To better understand the role of f OPDP in regulating prescription drug promotion promotion � To learn common violations found in prescription drug promotion prescription drug promotion � To learn about BadAd and how you can help stop misleading drug can help stop misleading drug promotion
FDA Structure FDA Structure Food and Drug Ad Administration i i t ti CDER CBER CDRH CFSAN CVM CTP ORA Center for Center for Center for Center for Center for Center for Office of Drug Biologics Devices Food Veterinary Tobacco Regulatory Evaluation Evaluation Evaluation Evaluation and and Safety Safety Medicine Medicine Products Products Affairs Affairs and and Radiological and Applied Research Research Health Nutrition
CDER Review (Approving) Divisions Office of New Drugs Office of New Drugs � Division of Pulmonary, Allergy, and � Division of Cardiovascular and Renal Rheumatology Products Products � Division of Dermatology and Dental � Division of Neurology Products Products � Division of Psychiatry Products � Division of Gastroenterology Products � Division of Antimicrobial Products Division of Antimicrobial Products � Division of Reproductive and Urologic � Division of Botanical Products Products � Division of Anesthesia and Analgesia g � Division of Medical Imaging Products Division of Medical Imaging Products Products � Division of Nonprescription Drug � Division of Metabolism and Products Endocrinology Products � Office of Hematology and Oncology Offi e of Hem tolog nd On olog Products
Office of Prescription Drug Promotion (OPDP) Mission: To protect the public health by assuring • prescription drug information is truthful, balanced and accurately communicated. y To guard against false and misleading • advertising and promotion through advertising and promotion through comprehensive surveillance, enforcement, and educational programs
What Does OPDP Do? What Does OPDP Do? � Advice to industry Advice to industry DRAFT promotional materials (VOLUNTARY in most • cases) • Launch materials for new drugs or new indications Launch materials for new drugs or new indications • Direct-to-consumer (DTC) broadcast ads • Non-launch materials • Advice within FDA � Draft labeling, including PPIs and Medication Guides � Cartons and product labels � Cartons and product labels � Dear Healthcare Provider letters � Pharmacoeconomics, health-related patient-reported outcome claims outcome claims
Wh t D What Does OPDP Do? OPDP D ? � Guidances and Policy Development � Research
What Does OPDP Do? What Does OPDP Do? • Surveillance S ill • Review materials submitted to OPDP at the time of initial dissemination (Form the time of initial dissemination (Form 2253) • Conferences Conferences • Complaints • Healthcare professionals p • Consumers • Competitors p
Wh t D What Does OPDP Do? OPDP D ? • Enforcement E f • Untitled Letters/Notices of Violation • Warning Letters • Injunction/Consent decrees • Seizures/Criminal actions S i /C i i l ti • Civil and monetary penalties
Wh t D What Does OPDP Regulate? OPDP R l t ? Written and printed prescription drug p p p g • promotional materials made by the company which include: TV commercials • Sales aids, journal ads, and patient brochures • Drug websites, e-details, webinars, Epocrates, • and email alerts Oral Presentations made by representatives • of the company which include: Sales Reps • Hired Spokespeople • Medical Science Liaisons •
# of Final Promotional Pieces S b Submitted (2253s) 2006 – 2011 itt d (2253 )
Direct-to-Consumer Drug Advertising Trends
DTC M th DTC Myths and Misperceptions d Mi ti � FDA “legalized” DTC advertising in the � FDA legalized DTC advertising in the late 1990’s � Industry spends most of its advertising y p g budget on DTC advertising � FDA has the authority to ban DTC advertising d ti i � FDA can restrict DTC advertising to certain types of products certain types of products � FDA approves DTC ads � FDA regulates “good taste” g g
Federal Food, Drug and Cosmetic Act (FFD&C Act) � Code of Federal Regulations (CFR) f � 202.1 - Prescription Drug Advertising � 312.7 - Preapproval Promotion 312 7 P l P i � 314.550 - Subpart H, Accelerated Approval Approval � 601.40 - Subpart E, Accelerated Approval for Biologics pp g
R Regulatory Authority l t A th it Post-Approval Regulations located in 21 CFR 314.81(b)(3): � Require the submission of all promotional R i th b i i f ll ti l materials at the time of initial dissemination or publication d a o o pub a o � Must include Form FDA-2253 and current PI � Received > 82K submissions last year � OPDP does not generally “pre-clear” promotional materials promotional materials
Compliance Compliance with FFD&C Act ith FFD&C Act • Must be consistent with approved M t b i t t ith d product labeling • Must be supported by substantial Must be supported by substantial evidence • Must not be false or misleading • Must not be false or misleading • Must have balance between efficacy and risk information • Must reveal all material information
Wh t i F l What is False or Misleading? Mi l di ? � Better or more effective than has been B ff i h h b demonstrated by substantial evidence � Safer (fewer side effects lower severity) � Safer (fewer side effects, lower severity) than has been demonstrated by substantial evidence � Comparative claims (better or safer than other products) without substantial evidence evidence � Misleading presentation of data � Promotion outside labeled uses � Promotion outside labeled uses
Common Violations Cited in Advisory Letters � Omission of Risk Information f f � Minimization of Risk Information � Broadening or Inadequate Communication of Indication � Overstatement of Efficacy/ Unsubstantiated Claims � Other Common Issues
O Omission of Risk Information i i f Ri k I f ti � Full product pieces include the name ll d l d h of the drug plus any representations or suggestions about the drug or suggestions about the drug � Promotional materials that make product claims must also provide risk product claims must also provide risk information � Contraindications Warnings � Contraindications, Warnings, Precautions, pertinent Adverse Events
Mi i Minimization of Risk Information i ti f Ri k I f ti � Omission of part of the risk described in the approved labeling/ lack of context � Inclusion of non-risk information in a risk � Inclusion of non risk information in a risk section, or vice versa � “Safety claims” � “Framing” � Layout/ prominence � Sequence � Sequence
Broadening/Inadequate C Communication of Indication i ti f I di ti � Implying drug is useful in a broader f population of patients or disease states than demonstrated states than demonstrated � Failing to disclose full indication, including limitations including limitations � Misleadingly characterizing the indication or disease state indication or disease state
Overstatement of Efficacy/ U Unsubstantiated Claims b t ti t d Cl i � Suggesting or representing drug is more efficacious than demonstrated � Guarantee of efficacy f ff � Survival/ Long-term outcome claims � Superiority/ comparative claims
Oth Other Common Issues C I � Misleading mechanism of action f claims � Minimization of role of healthcare f l f h l h professional � Omission/ minimization of O i i / i i i i f prescription status
C Communication Issues i ti I � Consumer-Friendly Language � Presentation of Data � Distraction � Competing Modalities
C Consumer-Friendly Language F i dl L � Audience for DTC promotion is f consumers � Typical consumer does not have l d h expert-level knowledge of medical terminology terminology � Efficacy and risk concepts should be in easily understood “friendly” in easily understood, friendly language
P Presentation of Data t ti f D t � Efficacy and risk data concepts may ff be misleading if not presented with adequate context for the consumer adequate context for the consumer to understand the concepts � Present as clearly as possible � Present as clearly as possible
Di t Distraction ti � Elements that distract the viewer may interfere with comprehension of both efficacy and risk concepts of both efficacy and risk concepts � Examples: flashing lights, quick scene changes vivid or scene changes, vivid or incompatible visuals or audio
C Competing Modalities ti M d liti � TV ads present several modalities to the viewer � Examples: l � Voiceovers � Superimposed statements S i d t t t � Graphics
Promotional Categories Promotional Categories � Help-Seeking Does not make Does not make � Institutional I i i l representations about a � Reminder specific product – Does not require fair balance � Coming Soon � Full Product
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