COMMON HEALTHCARE COMMUNICATION SITUATIONS
This section of the Resource Center is a quick reference library for some common healthcare communication situations – click on the one you’re interested in and you’ll be taken to pertinent resources.
Relationships with Promotional Speakers
(Recruiting, training, preparing, compensating, and contracting with speakers; media tours; speakers’ bureaus; spokespeople)
1. PhRMA Code (Pharmaceutical Research and Manufacturers of America’s Principles on Interactions with Healthcare Professionals) – PhRMA represents research-based pharmaceutical and biotechnology companies. Guidelines for interacting with healthcare professionals are addressed in the PhRMA Code, which has been updated and enhanced as of 7/1/08 and takes effect on 1/1/09.
View the Code Click here to see a copy of the PhRMA Code on Interactions with Healthcare Professionals
Analogous to the PhRMA Code for the Pharmaceutical industry is the “AdvaMed Code” for the Medical Devices industry:
2. AdvaMed Code (Advanced Medical Technology Association’s Code of Ethics on Interaction with Health Care Professionals) – AdvaMed’s member companies produce nearly 90% of the healthcare technology purchased annually in the US, and more than 50% around the world; this technology includes medical devices, diagnostic products, and health information systems. Guidelines for interacting with healthcare professionals are addressed in the AdvaMed Code, which also includes Frequently Asked Questions about the Code.
View the Code Click here to access AdvaMed’s Code of Ethics on Interaction with Health Care Professionals
3. ACCME (Accreditation Council for Continuing Medical Education) – ACCME’s stated mission is identifying, developing, and promoting standards, which apply to all CME providers, for quality continuing medical education (CME) utilized by physicians. The following are links to three sets of ACCME policies and standards applying to all CME providers:
View the Standards Click here to see a copy of the ACCME Accreditation Policies for CME Providers
View the Standards Click here to see a copy of the ACCME Standards for Commercial Support
View the Standards Click here to see a copy of the ACCME Essential Areas and Their Elements
4. Promotional Speakers: Regulatory Considerations
iiBIG Pharmaceutical Sales & Marketing Executive Congress
March-April, 2008
Glenn N. Byrd, Director, Regulatory Affairs, MedImmune
Regulatory guidelines and best practices in regard to promotional speakers, along with case studies and “do’s and don’ts” – learn about the most common errors in regard to the use of promotional speakers and how to avoid them.
View the Presentation Click here to view the presentation.
Establishing a Culture of Compliance
1. OIG Compliance Guidelines (Office of the Inspector General of HHS – “OIG Compliance Program Guidance for Pharmaceutical Manufacturers”)
In May, 2003, the OIG of the Department of Health and Human Services published in the Federal Register its guidelines stating the fundamental principles of compliance programs for pharmaceutical manufacturers. These Guidelines also detail the specific elements that pharmaceutical manufacturers should consider when developing and implementing an effective compliance program. The purpose of the Compliance Program Guidance is to encourage the use of internal controls to efficiently monitor adherence to applicable statutes, regulations, and program requirements, in order to prevent and reduce fraud and abuse in federal healthcare programs, such as Medicare and Medicaid.
View the Guidelines Click here to read the Guidelines
2. Agency Best Practice in Regulatory Compliance
Pharmaceutical Executive
Feb. 2, 2006
Wayne L. Pines, Ilyssa Levins
The pharmaceutical industry imposes higher standards on advertising, PR, and medical education agencies than any other industry, except perhaps the financial services sector. Agencies need to keep up with constantly changing rules for advertising and promoting drugs or devices.
Read the article Click here to read the article
3. Playing by the Rules
Communiqué
Feb. 8, 2006
Wayne L. Pines, Ilyssa Levins
Doing the right thing has taken on a new meaning for healthcare public relations professionals when it comes to regulatory compliance. That’s because doing the wrong thing no longer means you only receive a warning letter from the Food and Drug Administration (FDA). Non-compliant pharmaceutical, biotech, and medical device companies and their communication agencies can face criminal prosecution, corporate integrity agreements, negative media attention, loss of business, damage to reputation and high legal fees.
Read the article Click here to read the article
4. Designing an Effective Compliance Program
Regulatory Affairs Professionals Society (RAPS)
Training and Internal Compliance
May, 2008
Alan R. Bennett, Partner, Ropes & Gray LLP
After a review of the current enforcement environment and recent settlements, the principles and elements of an effective compliance program are described. Detailed guidelines are provided as to who should be trained on compliance, what that training should include, and how it should be scheduled and delivered.
View the Presentation Click here to view the PowerPoint presentation
Developing Compliant Materials
1. FDA Regulations (Prescription Drug Advertising)
[Note: sometimes referred to as 21 CFR, Part 202]
View the Regulations Click here to read the Regulations
2. Promotional Speakers: Regulatory Considerations
iiBIG Pharmaceutical Sales & Marketing Executive Congress
March-April, 2008
Glenn N. Byrd, Director, Regulatory Affairs, MedImmune
Regulatory guidelines and best practices in regard to promotional speakers, along with case studies and “do’s and don’ts” – learn about the most common errors in regard to promotional speakers and how to avoid them.
View the Presentation Click here to view the PowerPoint presentation
3. The Food and Drug Administration's Evolving Regulation of Press Releases: Limits and Challenges
Food and Drug Law Journal, Vol. 61, p. 623, 2006
William W. Vodra (Arnold & Porter LLP), Nathan G. Cortez (Southern Methodist University, Dedman School of Law), and David E. Korn (PhRMA)
This article discusses how the FDA has regulated press materials in the past, and how recent developments may signal new directions in the agency's regulatory approach. Over the past 20 years, the FDA has both broadened and scaled back its claims to authority over press statements Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux.
View the Abstract of this article Click here to view the abstract
NOTE: To view the entire text of this article, one must either be a Nexus/Lexus subscriber or purchase it as a reprint from the Food and Drug Law Journal (tel: (800) 956-6293); the full text is not available on the Internet.
4. DOJ Press Release Announcing the InterMune Settlement (10/26/06)
In 2006, InterMune, Inc, a Brisbane, CA, biopharmaceutical company, agreed to pay more than $36.9 million to resolve criminal charges and civil liabilities in connection with its alleged illegal promotion and marketing of its drug Actimmune. According to the DOJ, InterMune, in a press release, knowingly made “false and fraudulent claims for Actimmune that were not eligible for reimbursement because they were for unnecessary and/or off label uses.” The press release intentionally misrepresented the results from a company-sponsored study of this drug, thereby misleading physicians and the public to believe that the drug trial had been successful.
View the entire DOJ Press Release
Understanding the Risks of Non-Compliance
1. What’s Startling: The High Price of Regulatory Non-Compliance
iiBIG Pharmaceutical Sales & Marketing Executive Congress
March-April, 2008, Ilyssa Levins
The new rules of engagement for PR, marketing, advertising, medical affairs, and other forms of promotion and marketing require teams to keep up with many new rules and regulations – with a much steeper price than ever before for ignorance or naiveté. You will learn from Case Studies and be given a Road Map for Success in this ever-changing, more-restrictive regulatory environment.
View the Presentation Click here to view the PowerPoint presentation
2. Promotional Speakers: Regulatory Considerations
iiBIG Pharmaceutical Sales & Marketing Executive Congress
March-April, 2008
Glenn N. Byrd, Director, Regulatory Affairs, MedImmune
Regulatory guidelines and best practices in regard to promotional speakers, along with case studies and "do's and don'ts" – learn about the most common errors in regard to the use of promotional speakers and how to avoid them.
View the Presentation Click here to view the PowerPoint presentation
3. Regulation vs. Communication – Finding the Balance
Foreign Exchange Audio Conference
January, 2008
Ilyssa Levins
It's no wonder pharmaceutical companies are hyper-focused on regulatory compliance. For the first time ever, a physician was indicted for off-label promotion. Over the past two years, off-label promotion fines increased from $3 billion to $5 billion. Even company executives have been personally fined. Learn how to maintain the proper balance between promotional activities and regulatory guidelines.
Read the Presentation script Click here to download the Word document, which includes an Abstract of the presentation
Listen to the audio Webcast Click here to download the transcript
4. Legal Developments Affecting Public Relations Activities
Drug Information Association (DIA) Annual Workshop Presentation
February, 2008
Greg Levine, Ropes and Gray (Presentation made when he was partner, FDA/Healthcare Practice, Arnold & Porter LLP)
The meeting reviews the latest FDA enforcement actions, and how companies and their legal, regulatory, marketing, advertising, and PR consultants can do their jobs better. This workshop describes the current enforcement environment, providing Case Studies that detail the severe penalties that have resulted from non-compliant behavior.
View the Presentation Click here to view the PowerPoint presentation
Promoting Clinical Trials and Communicating Trial Results
1. PhRMA (Pharmaceutical Research and Manufacturers of America)
Principles on Clinical Trials – PhRMA represents research-based pharmaceutical and biotechnology companies. Guidelines for the disclosure of clinical trial results and the communicating of these results are addressed in the PhRMA principles.
View the Principles Click here to view the PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results