Actions and Detail Panel
Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices...
Thu, May 18, 2017, 9:00 AM – Fri, May 19, 2017, 6:00 PM CDT
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. 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.
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
- Identify and discuss the latest FDA and industry trends with statistics and data regarding enforcement and inspection data
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. This seminar will assist personnel who have varying levels of experience in drug and device advertising, marketing and promotion. It is intended for those involved with Regulatory Affairs, Marketing and promotional legal issues, Marketing, sales and support functions but could benefit other personnel. 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
- 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
- Marketing Communications
- Medical Information and Affairs
Day 1 Schedule
- Introductions and Background
- Advertising and Promotion Regulation Overview
- Required Elements of All Advertising and Promotional Materials for Drugs and Medical Devices
- Laws Governing Advertising and Promotion: FDA
- Promotion, Labeling and Advertising
- Misbranding/Off-Label Information and Issues
- In-Depth Analysis of Requirements for Advertising and Promotion
- FDA Enforcement Surveillance
- Social Media
- 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?
- Off-Label Promotion
- Medical Education
- 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?
- FDA and FTC Enforcement
- The FDA has an escalating arsenal of enforcement tools from informal notices to formal administrative notices to civil actions and finally to criminal prosecution.
Day 2 Schedule
- Untitled Letter and the Warning Letters
- Injunctions/Consent Decrees
- OIG/DOJ/False Claims Act and Other Acts and OIG Settlements/CIA's
- Physician Payments Sunshine Act
- The federal Anti-Kickback statute presents many potential pitfalls for medical device manufacturers looking to promote their products.
- Disclose risk information in prescription drug and medical device promotion appropriately and effectively to healthcare professionals and consumers
- Company Policies and Procedures
- AdvaMed Code of Ethics on Interactions with HCP's
- Integrating FDA compliance elements into Healthcare Compliance or Corporate Compliance programs and overview of the standards with HHS-OIG Guidance
- Recent Trends and Enforcement Actions
Recap of Day 1 and Day 2
Exercise on Day 2
- Interactive Discussions
- Review Regulatory and Compliance Documentation
David R. DillsRegulatory Affairs & Compliance Consultant,
David R. Dills, Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA, Design Dossiers, Technical Files, CMC, NDA, and IDE submissions, currently serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. His background encompasses broad capabilities in regulatory and compliance oversight and governance, including CAPA, Design Controls, Validation, Software Quality with regulatory oversight, FDA Mock Inspections, remediating documentation management systems, Supplier Quality, Adverse Event Reporting, Product Complaints, GxP Training, interpretation and applicability of FDA and international regulations and standards, postmarketing surveillance, ISO 13485 and CE Mark, Medical Device/IVD/Active Implantable Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EMEA and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.
NO REFUNDS ON REGISTRATIONS ALLOWED
NO TRANSFER ON REGISTRATIONS ALLOWED
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