This presentation covers the essential concept of ensuring all promotional communications are on label and the safe harbors established by FDA for disseminating off-label information compliantly.
FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Pharmacovigilanc: The science & activities relating to the Detection, Assessment, Understanding and Prevention of adverse effects or any other drug related problems
The Thalidomide Tragedy (Lessons for Drug Safety and Regulation)
CLASSIFICATION OF ADRS (RAWLIN AND THOMPSON CLASSIFICATION)
Why PV is Necessary?
Objective of PV
Outcomes of Drugs
Causal Relationship
Adverse drug reaction and causality assessment scales
Classification of AE
Serious Adverse Event (SAE)
Sources of Adverse Events (AE) reports
Sources of AE Reports(Solicited Reports)
What to Report?
Who to Report?
When to Report?
Individual case data flow
FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Pharmacovigilanc: The science & activities relating to the Detection, Assessment, Understanding and Prevention of adverse effects or any other drug related problems
The Thalidomide Tragedy (Lessons for Drug Safety and Regulation)
CLASSIFICATION OF ADRS (RAWLIN AND THOMPSON CLASSIFICATION)
Why PV is Necessary?
Objective of PV
Outcomes of Drugs
Causal Relationship
Adverse drug reaction and causality assessment scales
Classification of AE
Serious Adverse Event (SAE)
Sources of Adverse Events (AE) reports
Sources of AE Reports(Solicited Reports)
What to Report?
Who to Report?
When to Report?
Individual case data flow
Lifecycle Management in the Pharmaceutical IndustryAnthony Russell
Presented to students in the Drug Development and Product Management program at UC San Diego. Covers the rationale for lifecycle management is important. Includes case studies of successful implementation of lifecycle management. Presentation date: 2/5/2019.
FDA Regulation of Advertising and Promotion -- the BasicsMichael Swit
Presentation to the November 9-10, 2017 Course sponsored by ComplianceOnline, in Boston, MA, focusing on the basics of FDA regulation of drug and device advertising.
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
TSDP tells about Post-marketing Drug-surveillance and their types. To know more about regulatory medical writing training, contact- hello@turacoz.in. know more, visit: http://turacozskilldevelopment.org/
Fundamental concept of regulatory affairs in pharmaceutical & biotechnologyHitendra Singh
RA is a comparatively new profession which developed from the desire of governments to protect public health by controlling the Quality, safety and efficacy of products in areas including pharmaceuticals, Biotechnology, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Goals of Regulatory Affairs Professionals:-
Protection of human health
Ensuring safety, efficacy and quality of drugs
Ensuring appropriateness and accuracy of product information
Lifecycle Management in the Pharmaceutical IndustryAnthony Russell
Presented to students in the Drug Development and Product Management program at UC San Diego. Covers the rationale for lifecycle management is important. Includes case studies of successful implementation of lifecycle management. Presentation date: 2/5/2019.
FDA Regulation of Advertising and Promotion -- the BasicsMichael Swit
Presentation to the November 9-10, 2017 Course sponsored by ComplianceOnline, in Boston, MA, focusing on the basics of FDA regulation of drug and device advertising.
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
TSDP tells about Post-marketing Drug-surveillance and their types. To know more about regulatory medical writing training, contact- hello@turacoz.in. know more, visit: http://turacozskilldevelopment.org/
Fundamental concept of regulatory affairs in pharmaceutical & biotechnologyHitendra Singh
RA is a comparatively new profession which developed from the desire of governments to protect public health by controlling the Quality, safety and efficacy of products in areas including pharmaceuticals, Biotechnology, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Goals of Regulatory Affairs Professionals:-
Protection of human health
Ensuring safety, efficacy and quality of drugs
Ensuring appropriateness and accuracy of product information
Regulatory Considerations in Mobile ProgramsDale Cooke
This presentation looks at some of the unique considerations in developing mobile programs, especially mobile apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps. Topics covered include:
* FDA’s finalized Mobile Medical Applications—Guidance for Industry and Food and Drug Administration Staff
* Determination of whether a mobile app is a medical device subject to FDA enforcement action
* Scope of FDA’s regulatory discretion regarding mobile apps
* FDA’s conflicting guidance on dosage apps
* How to meet key requirements of promotional labeling in mobile programs
* The growing area of mobile apps as promotional messaging platforms
This presentation has appeal for anyone interested in adopting mobile tactics, whether that interest is in developing medical devices or making use of mobile tactics to promote pharmaceuticals or biologics.
The framework flow chart shown in this presentation is available here: http://ow.ly/qMxse
I delivered this presentation at the DTC National Conference in Washington DC. The presentation highlights the importance of mobile for people making decisions about their health and discusses how to present information about FDA-regulated products in this important channel.
With the explosion of social media and its growing importance, it’s critical for those in the pharmaceutical industry to understand how to leverage social networks compliantly to see positive results and minimize risk. If, and when, the FDA guidance on social media is final, questions will remain. This presentation helps the audience incorporate the latest social media technologies into acceptable and successful communications and marketing plans. Focus is given to regulatory requirements, types of communications, responsiveness, and dealing with adverse events.
Compliant Promotion in an On-demand WorldDale Cooke
The Internet is now the premier source of healthcare information for physicians and consumers alike. Consequently, FDA-regulated companies have been leveraging it in various ways, but compliance has proven challenging and confusing for companies not accustomed to digital tactics.
* Recent FDA enforcement actions that command the attention of anyone considering digital communication tactics
* Trends in digital media consumption and their impact on advertising effectiveness
* FDA’s 2009 Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion
* FDA’s 2011 Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications
*Some red flags guaranteed to draw FDA’s ire
* The latest on FDA social media guidance
Pharmaceutical companies have often been uncertain about how to meet their regulatory obligations while engaging in the new social media forums favored by consumers and physicians alike. FDA has released its first guidance addressing this topic since its 2009 hearings on the subject. The guidance addresses how sponsors can fulfill their requirement to file all material at the time of first use (the 2253 requirement) while engaging in real-time conversations.
This presentation examines key aspects of the guidance including:
* Status of user-generated content (UGC) and companies' reporting obligation for UGC
* Ability to meet 2253 filing requirements in the context of real-time conversations
* Implications of the guidance for filing online promotional materials other than social media
* Some open questions left unanswered by the guidance
DIA 2014 Marketing Pharmaceuticals Conf Marketing in Age of ObamaDale Cooke
This is my portion of the session I led at the DIA 2014 Marketing Pharmaceuticals Conference about the impact of some of the recent legislative changes on people responsible for marketing pharmaceuticals in the United States.
This presentation looks at some of the unique considerations in developing mobile programs, especially apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps.
PhillyCooke eCTD Submissions for Ad-PromoDale Cooke
This presentation was initially delivered at the NJ/NY RAPS chapter on November 19, 2015. It reviews the FDA guidance on providing ad-promo submissions in electronic and print formats, explains the complex nature of the guidance and its scope, and includes the latest from FDA on how the guidance is being implemented.
The Other Agency: An introduction to Pharma MarketingDale Cooke
This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.
This presentation was delivered to a webinar sponsored by Zinc Ahead on May 21, 2015, and provided an update about the current state of guidance from the FDA on the appropriate use of social media by prescription product manufacturers.
The Importance of Social Media for PharmaDale Cooke
These slides were used for the introductory remarks for the FDAnews Social Media Regulatory Affairs Summit June 24-25, 2015. The intention was to motivate the need for companies to engage in social media and to address some of the topics that are most difficult for pharma to address.
This deck was presented at the 2013 Food & Drug Law Institute's Advertising & Promotion conference. I provided advice to people responsible for the selection and/or upgrade of electronic promotional review systems used in the review and approval of marketing materials for prescription products.
Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...ClinosolIndia
Regulatory compliance is a crucial aspect of conducting clinical research, ensuring that studies meet the requirements and standards set by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and other relevant bodies. Here are some key points to navigate regulatory compliance in clinical research:
Familiarize Yourself with Applicable Regulations: Stay updated on the relevant regulations and guidelines that govern clinical research, including FDA regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and local regulatory requirements. Understand the specific regulations that apply to your study, such as those related to investigational new drugs (IND) or investigational device exemptions (IDE).
Obtain Institutional Review Board (IRB) Approval: IRBs play a crucial role in ensuring the protection of human subjects in research. Before initiating a clinical trial, obtain IRB approval by submitting a detailed study protocol, informed consent documents, and other required materials. IRBs review the study's scientific merit, ethical considerations, and compliance with regulations.
Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application: If your clinical research involves the use of investigational drugs or devices, you may need to submit an IND or IDE application to the FDA. These applications provide detailed information on the investigational product, its safety, efficacy, manufacturing processes, and proposed study design.
Good Clinical Practice (GCP) Guidelines: GCP guidelines provide a framework for the conduct of clinical research to ensure data integrity and participant protection. Adhere to GCP principles, including informed consent, protocol adherence, accurate documentation, and appropriate monitoring and reporting of adverse events.
Adverse Event Reporting: Monitor and report adverse events occurring during the study promptly. Follow the FDA's requirements for safety reporting, including expedited reporting of serious and unexpected adverse events. Maintain accurate and complete records of adverse events and their follow-up actions.
Data Integrity and Documentation: Ensure the integrity, accuracy, and traceability of study data. Implement robust data management practices, including proper documentation, source data verification, and secure storage of study documents. Follow regulatory requirements for data retention, including archiving study records for the required period.
Audits and Inspections: Be prepared for audits and inspections by regulatory agencies. Maintain organized and easily accessible study documentation, including study protocols, informed consent forms, case report forms, and correspondence with IRBs and regulatory agencies. Cooperate with auditors or inspectors and address any identified deficiencies or findings promptly.
Dr. Jules Mitchel, President of Target Health Inc., presents "How Creative Can One Be When Working with the FDA to Optimize the Drug and Device Development Process?" at the October 29 iCAN-Global Entrepreneur's Breakfast Forum.
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erin O'Reilly, PhD, RAC
Assoc. Director, Regulatory Affairs
Translational Medicine Institute
Introduces the basics of filing an Investigational New Drug (IND) Application with the FDA
This SlideShare gives an overview on how a drug is discovered, researched, developed, tested and reviewed for approval. It follows the current standard of approval set by the Food and Drug Administration (FDA), a federal agency of the United States Department of Health and Human Services. The process is generally divided into 4 Stages: Pre-Clinical, Clinical, New Drug Application (NDA) Review & Post-Marketing.
Keynote presentation at the Drug Delivery Conference, sponsored by Pharmaceutical Education Associates, in June 2007, in San Diego. Talk focused on new drug regulatory issues, especially those arising under draft legislation that would eventually lead to the 2007 Food and Drug Administration Amendments Act (FDAAA).
Review of key considerations in managing relationships between the sponsor of clinical study and the clinical investigator, including issues such as budget, GCP compliance, and what can go wrong if FDA takes enforcement action.
What’s Next in US Payor Communications: The Impact of FDA's Proposed Guidance...Nathan White, CPC
The recent enactment of the 21st Century Cures Act has profound immediate and long-term implications for development and communication of HEOR/RWE in the US, particularly in relation to communications with payors about healthcare economic information (HCEI). In January, the FDA released draft guidance for public comment to outline its thinking around communication to payors of HCEI, but there are still unanswered questions to be addressed in the final guidance. Industry will need to quickly establish new policies and procedures to maintain compliance with the new regulations, especially in relation to OPDP submission requirements – a steep transition from a space that has largely been unregulated.
Greeting From Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “9th Pharmacovigilance 2015” The conference will be held on 2nd September 2015, Kohinoor Continental Hotel, Mumbai, India.
KEY SPEAKERS:-
• V. Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission Ministry of Health and Family Welfare Govt. of India
• Arun Bhatt, President, ClinInvent Research
• Deepa Arora, Vice President - Pharmacovigilance & Global Head - Drug Safety & Risk Management, Lupin
• Bhaswat Chakraborty, Senior Vice President, Cadila
• Babita Kirodian, Head of Country Pharmacovigilance, Bristol Myers Squibb
• Nipom Deka, Regional Pharmacovigilance Manager, Asia, Africa & Middle East, Abbott
• Shashidhar Swamy, Head Pharmacovigilance, Wockhardt
• Mohammad Salim, Country Safety Lead, Pfizer
• Manish Verma, Director Medical Affairs, Sanofi
• Karthik Babu, Affiliate Pharmacovigilance Head, Sanofi
• Chirag Trivedi, Director & Head of Clinical Study Unit, Sanofi
• Priya Chatterjee, Director - Regulatory Affairs, Merck Serono
• Milind Antani, Partner In-Charge - Pharma LifeSciences, Nishith Desai Associate
• Anand Harugeri, Patient Safety and Regulatory Affairs Manager, Astrazeneca
• Deepti Sanghavi, Assistant Manager - Medical Writing, Tata Consultancy Services
• Sandeep Sewlikar, Manager – Clinical Affairs, Johnson and Johnson
• Girish Parhate, Head Regulatory Affairs, Bayer Pharmaceuticals
• Rajashri Survase Ojha, Founder and MD, Raaj GPRAC
• Vandana Jolad, Director, VIaTal Pharma
Plus Many More...
CONFERENCE BOOKING DETAILS:-
• Early Bird Discounted Price - Conference Delegate Pass (INR 6,000 + Tax (14%) per delegate) - Book and Pay before 20th July 2015 avail the early bird discounted price. You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in
• Standard Price after Early Bird Discounted Time – 1 or 2 Delegates (INR 7,000 + Tax (14%) per delegate) - You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in
• Group Discounts – 3 or 4 Delegates - (INR 6,500 + Tax (14%) per delegate)
• Group Discounts – 5 or more Delegates - (INR 5,000 + Tax (14%) per delegate)
• Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to TEL: +91 44 65515695, +91 9940043915 or swetha@virtueinsight.co.in
In case you or any of your colleagues might be interested in participating in the same, please let me know and I will be happy to call you and help you with the registration.
Thank you for your time and consideration. I look forward to hearing from you
Thanks,
Swetha
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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Hot Selling Organic intermediates
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
4. 4
“Safe & Effective”
Safe
> 1938 Food, Drug, and Cosmetic Act
> No regulatory definition, but gain
must outweigh risks
Effective
> 1962 Kefauver-Harris Drug
Amendments
> Effective for what?
> Establishes the notion of an
indication
> Two double-blind, placebo-
controlled studies
What is on label?
5. 5
What is off label?
Anything that is not in the approved label
6. 6
A typology of off-label promotion
Expansion to different disease entity
> Similar symptoms of a different disease
> Similar etiology of different disease
Broadening of indication
> Different patient populations
> Different stage/severity of a condition
Expansion of dosing schedule
Different route of administration
7. 7
A distinction
Off-Label Use
The use or direction to use an FDA-approved product in a manner
that is not indicated in the FDA-approved label
Off-Label Promotion
The activity of encouraging the use or direction to use an FDA-
approved product in a manner that is not indicated in the FDA
approved label
8. 8
The importance
“healthcare professionals may lawfully use or
prescribe [a] product for uses or treatment
regimens that are not included in the product's
approved labeling”
FDA Guidance for Industry, Good Reprint Practices for the Distribution of
Medical Journal Articles and Medical or Scientific Reference
Publications on Unapproved New Uses of Approved
Drugs and Approved or Cleared Medical Devices
9. 9
Implications
Off-label use is permissible
In fact…
off-label use accounts for 21% of all prescriptions.*
* Stafford, Randall. “Regulating Off-Label Drug Use—
Rethinking the Role of the FDA” NEJM 358; 14. April 3, 2008.
10. 10
A Further Distinction
Off-label promotion
The activity of encouraging the use or direction to use an FDA-
approved product in a manner that is not indicated in the FDA
approved label
Dissemination of off-label information
Providing information about uses of an FDA-approved product
that are not indicated in the FDA approved label
13. 13
What’s at stake?
$4.3 billion in False Claims Act recoveries in 2013
$19.2 billion in the past five years
14. 14
Corporate Integrity Agreements
Requirements of a CIA include:
• Hiring additional employees and outside consultants to ensure
compliance with a rigorous set of requirements
• Establishing new procedures and extensive documentation that all of
those procedures are followed precisely
• Signed certifications from the President of the company down to senior
brand leaders verifying that all procedures have been followed precisely
17. 17
Significant changes from previous guidance
Recognition of the different nature of text books from
journal articles
Clinical Practice Guidelines (CPG) inclusion
18. 18
Do’s & don’ts
Materials should be:
– Published by independent organization of experts with full
disclosure policy for conflicts
– Peer-reviewed
– Independently available (via subscription or purchase)
– Addressing adequate, well-controlled investigations
– Current
Materials should NOT be:
– Specially funded by manufacturer of the product
– Written, edited, or excerpted specifically for manufacturer
– Edited or influenced by anyone with financial ties to
manufacturer
19. 19
Additional constraints
Materials should NOT:
– Be false and misleading
– Pose a significant risk to public health
Unacceptable materials include:
– Letters to the editor
– Abstracts of publications
– Reports of healthy volunteer trials
– Publications with conclusions but little or no data for them
20. 20
How to disseminate
Materials disseminated should be:
– Unabridged
– Clean from any marks or highlighting
– Accompanied by approved product label
– Accompanied by comprehensive bibliography
– Disseminated with contrary results, where applicable
– Distributed separately from any promotional content
21. 21
How to disseminate (cont’d)
Permanently affixed information:
– Uses described are not FDA approved or cleared
– Manufacturer’s connection to the product
– Any author with a financial connection to manufacturer
– Any funders of the studies
– All risks and safety concerns related to the unapproved use
22. 22
CPG considerations
Disseminated CPGs should be trustworthy:
– Be based on a systematic review of existing evidence
– Knowledgeable, multidisciplinary panel of experts
– Consider patient subgroups and preferences
– Based on an explicit, transparent process minimizing distortion,
biases, and conflicts of interest
– Provide standardized recommendations, identifying strength of
the recommendation & quality of evidence
– Be reconsidered/revised as warranted by new evidence
25. 25
Solicited vs. unsolicited
Requests “prompted in any way” by manufacturer are solicited and
forbidden
Examples of solicited requests:
– Presenting off-label use data at promotional events
– Distributing information about ongoing research and soliciting inquiries
– Encouraging users to post videos about their experiences using
YouTube
– Announcing results of studies via Twitter suggesting safe and effective
use
– Sending information about off-label uses to people and encouraging
them to write about the uses in public forums
– Using URLs, phone numbers, etc., to imply off-label use
– Making off-label information accessible online via pull-down menus that
imply off-label use or searches that return results beyond the limited
question being asked
26. 26
Response process
Seven-step process
1. Provide information “only to the individual making the request
directly to the firm as a private, one-on-one communication.”
2. Information provided “should be tailored to answer only the
specific question(s) asked.”
3. Information “should be truthful, non-misleading, accurate, and
balanced.”
4. Information “should be scientific in nature.”
5. Information “should be generated by medical or scientific
personnel independent from sales or marketing departments.”
27. 27
Response process
6.Provide in addition to the specific off-label information requested:
– Current Labeling
– “A prominent statement notifying the recipient that FDA has not approved or cleared
the product as safe and effective for the use addressed in the materials provided”
– A “prominent statement” of the approved indication(s)
– “A prominent statement providing all important safety information including, if
applicable, any boxed warning for the product”
– Complete references for the off-label information
7.Maintain records of the request including:
– “The nature of the request for information, including the name, address, and affiliation
of the requestor”
– What information was provided
– Any follow-up by the requestor
28. 28
Common principles
Division of Labor:
– Science & Medicine responds to off-label requests
– Sales & Marketing promote products
Including the PI
Statement of the approved use(s)
Statement of the new use as unapproved
Information should be truthful, non-misleading
Always supply a balanced response including
appropriate risk information
Disclosure of all ties to manufacturer
30. 30
Dale Cooke
VP/Group Director, Regulatory
Dale Cooke is the head of the regulatory department for Digitas Health
LifeBrands. He has worked with more than 30 pharmaceutical and medical
device clients around the world from offices in Philadelphia, New York, Boston,
San Francisco, and London. Dale advises clients on FDA enforcement actions
and provides recommendations for compliance with FDA regulations, with a
focus on issues involving the Internet and emerging technology. His insights
have been featured in the Wall Street Journal’s Health blog, The Pink Sheet,
MedAdNews, PharmExec, and others. Dale is an active member of the
Regulatory Affairs Professionals Society (RAPS), Drug Information
Association (DIA), Food and Drug Law Institute (FDLI), and the Alliance for a
Stronger FDA. He also serves on the faculty of the University of California
San Francisco’s American Course in Drug Development Regulatory Sciences
program.
Dale is the author of Effective Review and Approval of Digital Promotional
Tactics, which is part of the FDLI’s primer series. He is regularly invited to
speak at industry conferences on topics including FDA enforcement trends,
best practices for review processes, global review practices, and life sciences
use of social media.
Dale earned his B.A. in Philosophy from Southern Methodist University and an
M.A. in Analytical Philosophy from the University of Arizona and studied
Epidemiology and Biostatistics at Drexel University’s School of Public Health
and Healthcare Compliance at Seton Hall University’s School of Law.