Advertising and Promotional Requirements for Drugs and Medical Devices
The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA"). How the FDA will deal with such advanced communication technology that can go "viral" and just as quickly disappear is the question that the industry is eager to have answered.
The FDA regulates the promotion of prescription drugs, biologics, medical devices and biotechnology products to ensure that the information is not false or misleading. The FDA has for decades regulated traditional advertising for decades, published various guidance documents for industry and issued many violation letters. If the FDA determines that drug or medical device promotional material is false or misleading or lacking in fair balance as between benefits and risks, companies could be forced to implement costly corrective actions, such as remedial advertising, suffer damage to their reputations and incur monetary fines. Already, the government has collected billions of dollars in fines, forfeitures and disgorgements from drug companies for the alleged marketing of a product for unapproved, or "off-label," uses.
In the worst case, responsible executives can be criminally prosecuted for such violations under a strict liability standard, meaning that the government is not required to show that the executive had any intent to violate FDA regulations or had any knowledge of such violations. In addition, Social Media is used by healthcare professionals, sales representatives and consumers to discuss the use of prescription products for specific diseases and conditions. The use of Social Media tools and potential concerns will be addressed.
Rx drug promotion is delivered to two distinct audiences: health care professionals (HCPs) and consumers. Although tasked with regulatory oversight, FDA recognizes that promotional efforts can provide HCPs as well as consumers important information about the newest developments in drug therapies. The value of such information depends upon the integrity and completeness of the information being presented.
FDA regulates all Rx drug "promotional materials," which includes both labeling and advertisements. Examples of "labeling" include, but are not limited to, brochures, booklets, detailing pieces, bulletins, calendars, motion pictures and slides. Advertisements include, but are not limited to, materials published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television and telephone communications systems. Rx drug advertising to doctors, known as "detailing," occurs in a variety of settings. In addition to medical offices, detailing occurs in hospitals, pharmacies, at medical meetings and symposia, academic settings, conferences and other meeting facilities. The FDA also regulates direct-to-consumer (DTC) Rx drug advertising.
The Food, Drug, and Cosmetic Act (FDCA) generally provides that a "drug or device shall be deemed to be misbranded...if it's labeling is false or misleading in any particular." The statute defines labeling to include any "written, printed, or graphic matter" (1) upon a drug itself, its immediate or other "containers or wrappers," or (2) "accompanying such article." FDA and courts interpret labeling broadly to encompass a variety of printed or written materials supplied by a manufacturer, packer or distributor, or disseminated on behalf of a manufacturer or distributor. FDA has jurisdiction over all drug and medical device labeling, including "promotional labeling," a term which FDA uses but does not differentiate from "labeling" as defined in the FDCA and related regulations. In determining whether a drug or device is misbranded due to misleading labeling, FDA takes into account not only representations made about the drug or device, "but also the extent to which the labeling . . . fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article . . . under the conditions of use prescribed in the labeling or advertising . . . or under such conditions of use as are customary or usual." Consequently, the authors point out the first distinction between FDA's regulation of drug and device promotion. Specifically, "while FDA has complete jurisdiction over prescription drug labeling and advertising, as well as all medical device labeling, it has limited jurisdiction over medical device advertising."
Questions typically addressed, included but not limited, to the following:
• Does the FDA control advertisements for all drugs?
• Does the FDA review and approve all advertisements for drugs before their release?
• Does Federal law ban ads for drugs that have serious risks?
• Does the FDA require drug companies to use hard-to-understand medical language in ads directed to consumers?
• Can the FDA limit the amount of money spent on prescription drug ads?
• Does the FDA work with drug companies to create prescription drug ads?
• Does the FDA approve ads for prescription drugs before they are seen by the public?
• What must product claim ads tell you?
• What are ads not required to tell you?
• Does the law say anything about the design of ads for prescription drugs?
• Has FDA done research on DTC advertising?
• How can an ad violate the law?
• Who should I tell if I think that a prescription drug ad violates the law?
• What does FDA do if it determines that an ad violates the law?
• What is Off-Label and the consequences with HCP's?
• Why FDA has complete jurisdiction over prescription drug labeling and advertising, as well as all medical device labeling, but has limited jurisdiction over medical device advertising?
Why should you attend?
• Gain a better understanding of how the regulatory and legal environment has evolved and affects the marketing and promotion of pharmaceuticals and medical devices
• Receive practical, day-to-day guidance based from the latest FDA enforcement actions, and the changes taking place and being contemplated
• Get a first-hand update on the status of social media guidance documents
• Identify the trends reflected in the latest enforcement actions and policies issued by the FDA
• Discuss the policies and actions being taken by OIG and DOJ under the False Claims Act and other Acts
• Summarize regulations, enforcement actions, guidelines and trends affecting the advertising and promotion of medical devices and drugs
• Identify key regulatory issues surrounding complex and rapidly shifting hot topics in advertising and promotion
• Conduct risk assessments for products and promotional strategies
• Reviews of business plans to identify potential misbranding issues
• Evaluate substantiation for promotional claims and potential clinical studies
• Integrating FDA compliance elements into Healthcare Compliance or Corporate Compliance programs
• Support the regulatory oversight for all advertising and promotional materials
• Assure that advertising and promotional materials meet applicable regulatory requirements
• Support regulatory submissions to the FDA's Division of Drug Marketing Advertising and Communications (DDMAC)
• Development and implementation of training sessions and materials specific to regulatory compliance of advertising and promotional materials
• Support the evaluation of data to support marketing claims
• The basics of FDA law and regulations governing advertising and promotion, as well as affiliated agencies such as the FTC, which shares jurisdiction with FDA on certain regulated products (e.g., OTC drugs).
• The distinctions between labels, labeling and advertising and how that impacts FDA's powers and how to properly position Direct-to-Consumer (DTC) promotions
• The Dos and Don'ts of promoting products on the internet, including social media sites and recent concerns
• Issues with off-label promotion, including criminal and civil actions that have led to multi-billion dollar settlements by regulated drug companies
• When disseminating medical educational materials crosses the line into improper promotion
• Key considerations on how to implement appropriate procedures and controls in your company to minimize the potential for regulatory action by the FDA or the FTC relative to promotion and advertising.
• Recognizing when inspectional findings or events indicate potential regulatory actions
• Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion as applicable
• Review and discuss pain points, challenges and solutions
• How to Avoid Adverse Inspections and Warning Letters - its simple - COMPLY!
• Identify and discuss the latest FDA and industry trends with statistics and data regarding enforcement and inspection data
• Leave the seminar with a better understanding of advertising and promotional requirements and expectations and being better prepared for FDA and "state of readiness"
Who Will Benefit:
This seminar will provide an overview and in-depth snapshot of the key principles and requirements for advertising and promotion expectations and ensuring compliance success. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the advertising and promotional requirements for drugs and medical devices, including:
• Management responsible for regulatory and GMP/GLP/GCP compliance and seeking a better understanding of FDA, advertising and promotional requirements, regulatory actions and how they can improve their own firm's operations and monitoring of their state of compliance and meeting requirements
• Individuals who come in contact with regulatory inspectors
• Compliance/Regulatory affairs professionals
• QA/QC professionals
• Senior management executives (CEO, COO, CFO, etc.)
• Manufacturing managers, supervisors & personnel
• Project Managers
• Regulatory Affairs Management
• Regulatory Affairs Specialist
• Compliance Officer
• Compliance Specialist
• Clinical Affairs
• Quality Assurance Management
• Marketing & Sales
• Distributors/Authorized Representatives
• Legal Counsel
• Engineering/Technical Services
• Marketing Communications
• Medical Information and Affairs
Lecture 1: Required Elements of All Advertising and Promotional Materials for Drugs and Medical Devices
Lecture 2: Promotion, Labelling and Advertising
Lecture 3: Misbranding/Off-Label Information and Issues
Lecture 4: FDA Enforcement Surveillance
Lecture 5: Social Media
Lecture 6: Enforcement Tools
Lecture 7: The FDA has an escalating arsenal of enforcement tools from informal notices to formal administrative notices to civil actions and finally to criminal prosecution.
Lecture 8: Untitled Letter and the Warning Letters
Lecture 9: Seizures
Lecture 10: Injunctions/Consent Decrees
Lecture 11: OIG/DOJ/False Claims Act and Other Acts and OIG Settlements/CIA's
Lecture 12: Physician Payments Sunshine Act
Lecture 13: The federal Anti-Kickback statute presents many potential pitfalls for medical device manufacturers looking to promote their products.
Lecture 14: Disclose risk information in prescription drug and medical device promotion appropriately and effectively to healthcare professionals and consumers
Lecture 15: Company Policies and Procedures
Lecture 16: AdvaMed Code of Ethics on Interactions with HCP's
Lecture 17: Integrating FDA compliance elements into Healthcare Compliance or Corporate Compliance programs and overview of the standards with HHS-OIG Guidance
Lecture 18: Recent Trends and Enforcement Actions
David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He has been involved in many FDA and other regulatory inspections as well as part of multiple FDA remediation activities involving CIA's Consent Decrees, Seizures and other enforcement actions, including responding to Warning Letters. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, addresses all aspects of postmarketing requirements involving advertising, promotional and labeling claims, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.
Date, Venue and Time:
Date: September 4th and 5th, 2014
Time: 9 am to 6 pm EDT
Venue: Courtyard Chicago O'Hare
Address: 2950 S. River Road Des Plaines Illinois 60018 USA
Price: $1295.00 (Seminar for One Delegate)
Discount: Register now and save $200. (Early Bird)
Until August 15, Early Bird Price: $1,295.00
From August 16 to September 02, Regular Price: $1,495.00
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