September 9, 2009 webinar sponsored by The Weinberg Group, with a focus on FDA's renewed commitment to enforcement announced by FDA Commissioner Hamburg on August 6, 2009, with a focus on:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance
Culture – The August 6, 2009 Speech and its Impact
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA Enforcement -- the Perils of Inadequate ComplianceMichael Swit
Presentation covers:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance Culture –The August 6, 2009 Speech and its Impact
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA Enforcement -- the Perils of Inadequate ComplianceMichael Swit
Presentation on December 3, 2009 to Southern California Biomedical Council Regulatory Workshop, Irvine, CA, with a focus on:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance
Culture – The August 6, 2009 Speech and its Impact
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA Inspections: Handling the Consequences. Dealing with the aftermath of an...Michael Swit
Presentation at annual MAGI conference, focusing on FDA inspections, covering:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance Culture –The August 6, 2009 Speech and its Impact
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA Warning Letters: Key Legal and Tactical Issues in Dealing with FDA's "Sh...Michael Swit
April 30, 2014 webinar sponsored by Duane Morris, with a focus on:
• Why FDA Issues Warning Letters – and How the
Agency Expects Management to Act When You Get
One
• How to Respond to A Warning Letter
• Inspection Responses That Failed to Hold Off FDA
From Issuing a Warning Letter (quick review)
• FDA Powers Beyond the Warning Letter – What the
Agency Can Do to You if It Does Not Like Your Reply
• The Evidentiary Status of a Warning Letter in Other
Litigation – J&J v. State of Arkansas
Presentation at ACI Conference on FDA Enforcement, covered:
Warning Letters, FDA Case Referral Process/Role of DOJ and U.S. Attorney, Coordination with States, Collateral Consequences of FDA Enforcement Actions
A guide for how to survive a FDA Warning letter. So you got at FDA 483 and now you have a FDA Warning Letter, learn how to survive the storm. For more information go to http://compliance-insight.com/fda-483-warning-letters/
Overcoming Regulatory, Clinical and Quality Challenges in Developing Combinat...Michael Swit
Webinar presented on May 19, 2011, sponsored by The Weinberg Group, focusing on:
* A Brief History of Combination Product Regulation
* Primary Mode of Action (PMOA) –The Key Lynchpin to FDA’s Regulatory Regime for Combination Products
* The Request for Designation (RFD) Process
* GMPs
* Post-Market Safety Reporting
* How Many Applications to File?
* User Fees
FDA Enforcement -- the Perils of Inadequate ComplianceMichael Swit
Presentation covers:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance Culture –The August 6, 2009 Speech and its Impact
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA Enforcement -- the Perils of Inadequate ComplianceMichael Swit
Presentation on December 3, 2009 to Southern California Biomedical Council Regulatory Workshop, Irvine, CA, with a focus on:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance
Culture – The August 6, 2009 Speech and its Impact
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA Inspections: Handling the Consequences. Dealing with the aftermath of an...Michael Swit
Presentation at annual MAGI conference, focusing on FDA inspections, covering:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance Culture –The August 6, 2009 Speech and its Impact
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA Warning Letters: Key Legal and Tactical Issues in Dealing with FDA's "Sh...Michael Swit
April 30, 2014 webinar sponsored by Duane Morris, with a focus on:
• Why FDA Issues Warning Letters – and How the
Agency Expects Management to Act When You Get
One
• How to Respond to A Warning Letter
• Inspection Responses That Failed to Hold Off FDA
From Issuing a Warning Letter (quick review)
• FDA Powers Beyond the Warning Letter – What the
Agency Can Do to You if It Does Not Like Your Reply
• The Evidentiary Status of a Warning Letter in Other
Litigation – J&J v. State of Arkansas
Presentation at ACI Conference on FDA Enforcement, covered:
Warning Letters, FDA Case Referral Process/Role of DOJ and U.S. Attorney, Coordination with States, Collateral Consequences of FDA Enforcement Actions
A guide for how to survive a FDA Warning letter. So you got at FDA 483 and now you have a FDA Warning Letter, learn how to survive the storm. For more information go to http://compliance-insight.com/fda-483-warning-letters/
Overcoming Regulatory, Clinical and Quality Challenges in Developing Combinat...Michael Swit
Webinar presented on May 19, 2011, sponsored by The Weinberg Group, focusing on:
* A Brief History of Combination Product Regulation
* Primary Mode of Action (PMOA) –The Key Lynchpin to FDA’s Regulatory Regime for Combination Products
* The Request for Designation (RFD) Process
* GMPs
* Post-Market Safety Reporting
* How Many Applications to File?
* User Fees
Successfully Responding to FDA Inspections (483s) & Warning LettersMichael Swit
November 10, 2015 webinar sponsored by Compliance2Go reviewing key issues and tactics associated with dealing with a company's reply to an FDA inspection and related warning letters. Includes lessons from actual responses.
Please find the an attachment which contains writing an effective 483 response to the regulatory authority. Please feel free to request the copy if interested.
How to succeed when you get a FDA 483 form letter. What to do and how to handle your FDA 483. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-observations/
Safety & Regulatory Solutions for Small and Medium-sized Life Science Organiz...Covance
A key issue for small and medium-sized enterprises is the optimal utilization of their limited resources for moving their product pipeline through clinical development, and launching and marketing their approved product(s). This is further heightened as both clinical trials and post-marketing activities continue to grow in complexity and scope due to stringent regulatory pressures, patient involvement and globalization. Yet companies face overwhelming pressure to get their product to market as quickly as possible.
Product Complaints: Complaint Handling from Intake to ClosureGRCTS
Overview :
An effective complaint handling system is an extremely important part of any quality system whether you are a medical device or pharmaceutical manufacturer. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include: process/procedure, trained personnel, and proper record keeping. Complaint handling is no easy task. Management might overlook the importance of customer feedback and be unable to capture all complaints coming from disparate sources. Plus, the additional regulatory reporting requirement related to adverse events may seem overly burdensome to device makers in particular. A strategic risk-based methodology can help streamline the complaint-handling process in medical device manufacturing.
Pharmacovigilance Audits: Is the USA behind the curve?Medpace
Key takeaways from this presentation are:
•The recognition of the importance of Pharmacovigilance Audits
•To influence the industry to see Pharmacovigilance audits as an effective tool in drug development
The PV audit ensures that a company’s drug safety and pharmacovigilance operations comply with applicable laws, regulations and guidances worldwide, and compare to best practices for organizations of similar size.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceutic
A Regulatory Strategy for your Medical DeviceEMMAIntl
Laying out a regulatory strategy for your product that visualizes the steps taken to bring a new or modified product to market could be one of the smartest decisions you can take as a start-up company. The regulatory strategy describes the approach that will be used to meet the regulatory requirements, as well as known industrial standards...
FDA Enforcement: The Cop is Back – How Enhanced Enforcement Can Impact You a...Michael Swit
December 15, 2010 webinar sponsored by The Weinberg Group on increased FDA enforcement activity under the Obama administration, with a focus on:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance Culture –The August 6, 2009 Speech and its Impact
Key FDA Enforcement Actions
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA’s Record under Enhanced Compliance
FDA Regulation of Advertising and Promotion -- Handling Promotional Complianc...Michael Swit
November 10, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
Successfully Responding to FDA Inspections (483s) & Warning LettersMichael Swit
November 10, 2015 webinar sponsored by Compliance2Go reviewing key issues and tactics associated with dealing with a company's reply to an FDA inspection and related warning letters. Includes lessons from actual responses.
Please find the an attachment which contains writing an effective 483 response to the regulatory authority. Please feel free to request the copy if interested.
How to succeed when you get a FDA 483 form letter. What to do and how to handle your FDA 483. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-observations/
Safety & Regulatory Solutions for Small and Medium-sized Life Science Organiz...Covance
A key issue for small and medium-sized enterprises is the optimal utilization of their limited resources for moving their product pipeline through clinical development, and launching and marketing their approved product(s). This is further heightened as both clinical trials and post-marketing activities continue to grow in complexity and scope due to stringent regulatory pressures, patient involvement and globalization. Yet companies face overwhelming pressure to get their product to market as quickly as possible.
Product Complaints: Complaint Handling from Intake to ClosureGRCTS
Overview :
An effective complaint handling system is an extremely important part of any quality system whether you are a medical device or pharmaceutical manufacturer. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include: process/procedure, trained personnel, and proper record keeping. Complaint handling is no easy task. Management might overlook the importance of customer feedback and be unable to capture all complaints coming from disparate sources. Plus, the additional regulatory reporting requirement related to adverse events may seem overly burdensome to device makers in particular. A strategic risk-based methodology can help streamline the complaint-handling process in medical device manufacturing.
Pharmacovigilance Audits: Is the USA behind the curve?Medpace
Key takeaways from this presentation are:
•The recognition of the importance of Pharmacovigilance Audits
•To influence the industry to see Pharmacovigilance audits as an effective tool in drug development
The PV audit ensures that a company’s drug safety and pharmacovigilance operations comply with applicable laws, regulations and guidances worldwide, and compare to best practices for organizations of similar size.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceutic
A Regulatory Strategy for your Medical DeviceEMMAIntl
Laying out a regulatory strategy for your product that visualizes the steps taken to bring a new or modified product to market could be one of the smartest decisions you can take as a start-up company. The regulatory strategy describes the approach that will be used to meet the regulatory requirements, as well as known industrial standards...
FDA Enforcement: The Cop is Back – How Enhanced Enforcement Can Impact You a...Michael Swit
December 15, 2010 webinar sponsored by The Weinberg Group on increased FDA enforcement activity under the Obama administration, with a focus on:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance Culture –The August 6, 2009 Speech and its Impact
Key FDA Enforcement Actions
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA’s Record under Enhanced Compliance
FDA Regulation of Advertising and Promotion -- Handling Promotional Complianc...Michael Swit
November 10, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Co...Michael 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 23, 2018
FDA Enforcement & Compliance for Medical DevicesMichael Swit
Presentation to the Food & Drug Law Institute (FDLI) Introduction to Medical Device Law, with a focus on:
* FDA Jurisdiction to Enforce
* Prohibited Acts and Penalties
* Inspections – FDA’s Prime Enforcement Tool
* Other “Cops on the Beat”
* Commissioner Hamburg’s Enforcement Initiative
Ensuring FDA Regulatory Success for Biomedical CompaniesMichael Swit
February 27, 2008 presentation to the Israeli Life Sciences Fellows of the Merage Foundation on product development issues, including:
* Overall Planning
* Working With FDA
* Clinical Trial Execution
* CMC and Design History Issues
* Safety Issues
* Labeling
* Ingredients –Active And Inactive; Component for Medical Devices
Successfully Responding to FDA Inspections (483s) & Warning LettersMichael Swit
Presentation reviewing key issues and tactics associated with dealing with a company's reply to an FDA inspection and related warning letters. Includes lessons from actual responses.
Successfully Responding to FDA Inspections (483s) & Warning LettersMichael Swit
Presentation reviewing key issues and tactics associated with dealing with a company's reply to an FDA inspection and related warning letters. Includes lessons from actual responses
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Suc...Michael Swit
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
REGULATORY AND OTHER PITFALLS IN DRUG DEVELOPMENTMichael Swit
Presentation to the San Diego Chapter of the American Chemical Society on on contemporary regulatory issues in drug development, with an emphasis on:
Overall Planning
Working With FDA
Clinical Trial Execution
CMC Issues
Safety Issues
Labeling
Ingredients – Active And Inactive
Drug Development in Today's Regulatory EnvironmentMichael Swit
Webinar sponsored by NanoTecNexus (www.http://nanotecnexus.org/) on contemporary regulatory issues in drug development, with an emphasis on:
Overall Planning
Working With FDA
Clinical Trial Execution
CMC Issues
Safety Issues
Labeling
Ingredients – Active And Inactive
Drug Safety: Perspectives on Industry's Duties in the Post-Vioxx Age.Michael Swit
Presentation to the Food & Drug Law Institute (FDLI) on Drug Safety with commentary on what are the emerging duties that industry may have to undertake in order to stay ahead of safety issues and avoid related products liability exposure.
The Small Company Clinical Study Sponsor -- Roles & Duties Vis-à-vis LiabilityMichael Swit
September 24, 2014 presentation to the Outsourcing in Clinical Trials: Southern California Conference, sponsored by Arena Conferences, focusing on:
* Clarifying exactly what you are responsible for and what you made be held accountable for
* Analyzing degrees of liability between bigger and smaller companies
* Ensuring that you are enforcing compliance from your outsourcing partners to avoid repercussions on yourselves
* Determining aspects of your trial management that you should retain in-house as a minimum so as to avoid liability issues
* Explaining to funders why quality and risk-assessments are a necessary expenditure above the cheapest options
FDA Enforcement – Trends, Powers and Penalties Or “Why Crime Does Not Pay”Michael Swit
June 12, 2009 presentation to the Southern California Biomedical Council on FDA enforcement, with a focus on:
FDA Regulatory/Enforcement Authority --
Understanding
FDA Enforcement Trends
Drugs
Devices
Clinical Trials
Collateral Consequences of FDA Violations
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Com...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston.
What to Learn from US FDA Warning Letters and Their Impact on Pharmacovigilan...Covance
Drug safety and pharmacovigilance (PV) are paramount to the development of new drugs and the continued use of approved medications. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
Drug Safety – Perspectives on Industry’s Duties in the Post-Vioxx AgeMichael Swit
Presentation to the Orange County Regulatory Affairs (OCRA) Discussion Group/FDA Joint Annual Educational Conference. June 2009., focusing on:
FDA’s Enhanced Drug Safety Powers
FDAAA and REMS
REMs in Action
What Should Industry Be Doing?
Understanding potential liability
“Avoiding” Liability
What Else Might FDA Do to Assure Drug Safety?
or What Should Industry Be Prepared For?
A Side Note on Products Liability and Drug Safety in
the Wake of Wyeth v. Levine
Similar to FDA’s New Strategy on Enforcement: The Growing Perils of Inadequate Compliance (20)
GMP Review -- Legal Letter from America Column -- How Data Integrity Issues S...Michael Swit
Article appearing in the October 2018 issue of GMP Review by Michael A. Swit explores how data integrity issues sunk a $4.3 billion acquisition of Akorn by Fresenius. Article stresses lessons not just for quality professionals, but also their top management.
FDA Regulation of Promotion & Advertising -- Part 7: FTC RegulationMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,
FDA Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-Lab...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 5: Social Media & InternetMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Action...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 3: Disseminating Scientific...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising --Part 2: Direct-to-Consumer AdsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 1-2, 2018, Boston
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, November 1-2, 2018, Boston.
Presentation on Critical Legal Issues Facing GMP ComplianceMichael Swit
August 27, 2018 Presentation to the 23rd Annual GMP by the Sea Conference in Cambridge, Maryland, focusing on the potential legal consequences faced by companies that violate FDA's requirements on Good Manufacturing Practices (GMPs) for drugs and biologics
Overview of FDA Drug Manufacturing RequirementsMichael Swit
Presentation on FDA Regulation of Drug Manufacturing to the Introduction to Drug Law Course sponsored by the Food & Drug Law Institute (FDLI) on July 25, 2018 in San Francisco.
Combination Products, Orphan Drugs, and OTC DrugsMichael Swit
Presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Exam review course on FDA regulation of combination products, orphan drugs, and OTC drugs.
Latest Developments in and the Future of the Regulatory Landscape for Approv...Michael Swit
Presentation on "Latest Developments in and the Future of the
Regulatory Landscape for Approving Treatments
for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference.
June 25, 2018. San Diego, CA.
June 14, 2018 presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Review Course on the basics of FDA regulation of generic drugs and biosimilars.
Recent FDA Developments in Digital Health & Clinical Decision Support SoftwareMichael Swit
June 7, 2018 presentation at the 4th Annual Medical Device Summit, sponsored by ComplianceOnline, in San Francisco, focusing on the impact of the 21st Century Cures Act and other developments on how FDA regulates software in the medical device arena, including mobile medical applications.
FDA Inspections: Handling the Consequences -- or Understanding How Ugly It C...Michael Swit
Presentation to the MAGI Clinical Research Conference – 2018 East, given on May 22, 2018 in Arlington, Virginia, and focusing on the collateral consequences of negative FDA inspections in the clinical research arena
In 2020, the Ministry of Home Affairs established a committee led by Prof. (Dr.) Ranbir Singh, former Vice Chancellor of National Law University (NLU), Delhi. This committee was tasked with reviewing the three codes of criminal law. The primary objective of the committee was to propose comprehensive reforms to the country’s criminal laws in a manner that is both principled and effective.
The committee’s focus was on ensuring the safety and security of individuals, communities, and the nation as a whole. Throughout its deliberations, the committee aimed to uphold constitutional values such as justice, dignity, and the intrinsic value of each individual. Their goal was to recommend amendments to the criminal laws that align with these values and priorities.
Subsequently, in February, the committee successfully submitted its recommendations regarding amendments to the criminal law. These recommendations are intended to serve as a foundation for enhancing the current legal framework, promoting safety and security, and upholding the constitutional principles of justice, dignity, and the inherent worth of every individual.
Car Accident Injury Do I Have a Case....Knowyourright
Every year, thousands of Minnesotans are injured in car accidents. These injuries can be severe – even life-changing. Under Minnesota law, you can pursue compensation through a personal injury lawsuit.
A "File Trademark" is a legal term referring to the registration of a unique symbol, logo, or name used to identify and distinguish products or services. This process provides legal protection, granting exclusive rights to the trademark owner, and helps prevent unauthorized use by competitors.
Visit Now: https://www.tumblr.com/trademark-quick/751620857551634432/ensure-legal-protection-file-your-trademark-with?source=share
Responsibilities of the office bearers while registering multi-state cooperat...Finlaw Consultancy Pvt Ltd
Introduction-
The process of register multi-state cooperative society in India is governed by the Multi-State Co-operative Societies Act, 2002. This process requires the office bearers to undertake several crucial responsibilities to ensure compliance with legal and regulatory frameworks. The key office bearers typically include the President, Secretary, and Treasurer, along with other elected members of the managing committee. Their responsibilities encompass administrative, legal, and financial duties essential for the successful registration and operation of the society.
FDA’s New Strategy on Enforcement: The Growing Perils of Inadequate Compliance
1. FDA’s New Strategy on Enforcement: The
Growing Perils of Inadequate Compliance
Presented by:
Michael A. Swit, Esq., Vice President
Matthew R. Weinberg, CEO
Moderated by:
Jeff Antos, Vice President
September 9, 2009
2. Today's Presenters
Michael A. Swit, Esq.
Vice President
Encinitas, CA
+1 760.633.3343
michael.swit@weinberggroup.com
Mr. Swit has been addressing critical FDA legal and regulatory issues since
1984. His expertise includes product development strategies, compliance
and enforcement initiatives, recalls and crisis management, FDA regulatory
activities, labeling and advertising, and clinical research efforts. Mr. Swit
develops and ensures the execution of a broad array of regulatory and
other services to clients, both directly and through outside counsel.
Matthew R. Weinberg
CEO
Washington, DC
+1 202.833.8077
matthew.weinberg@weinberggroup.com
Matthew Weinberg is Chief Executive Officer at The Weinberg Group,
an international scientific and regulatory consulting firm. Mr. Weinberg’s
area of expertise is in compliance and quality management, with an
emphasis on providing strategic and operational assistance. He helps
clients improve their manufacturing processes and serves as a testifying
expert on compliance-related matters.
2
3. What We Will Cover
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance
Culture – The August 6, 2009 Speech and its Impact
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
3
9. Hamburg: Why We Need
Effective FDA Enforcement
Conceded FDA enforcement efforts have been deficient
Five key benefits of effective enforcement:
Protect public health by promptly intercepting unsafe or
fraudulent products – prevents additional harm
Deter others who might violate law
Informs public of potential harm
Creates level playing field for industry
Instill public confidence in FDA
9
10. Vigilance – both FDA and Industry
FDA – Regular inspections and follow-ups
Companies
Must work quickly and thoroughly to correct problems
Must understand
if you cross the line, “you will be caught”
If you fail to act, FDA will
Strategic enforcement –
Greater focus on significant risks and violations
More meaningful penalties to “send a strong message to
discourage future offenses”
Hamburg: Four Essential Elements for
Effective FDA Enforcement
10
11. Four Essential Elements for
Effective Enforcement …
Quick action – FDA must respond rapidly, especially to:
Egregious violations
Violations that threaten the public health
Visible efforts – FDA must show all stakeholders it is on
the job
Will publicize enforcement actions widely – including rationales
for action
Goal:
Increase confidence in FDA
Deter non-compliance
11
12. Hamburg: Six New FDA
Enforcement Mandates
Impose clear post-inspection deadlines
Generally – no more than 15 business days to respond 483
After that, agency can issue warning letter or take other
enforcement action
Speed the warning letter process – by limiting review
by FDA Office of Chief Counsel to warning letters that
present significant legal issues
Work more closely with FDA’s regulatory partners
Example: in some cases, such as food safety, state, local, and
international officials can act more quickly than the FDA
When public health is at risk, the agency will coordinate with
its regulatory partners to take rapid action
12
13. Six New Enforcement Mandates …
Prioritize follow-up on all warning letters and other
enforcement actions
FDA will work quickly to assess the corrective action taken by industry
after a warning letter, a major product recall, or other enforcement action
Via new inspection or other form of investigation
FDA will be prepared to take immediate action to respond to
public health risks
Actions may occur before a formal warning letter is issued – at any time
Days of multiple responses to inspections – over
Develop and implement a formal warning letter “close-out”
process
If FDA determines a firm fully corrected violations in a warning letter,
agency will issue an official “close-out” notice and post on FDA Web site
Seen as an “important motivator” for corrective action
13
14. Enhanced Enforcement In Action –
Timely 483 Responses Policy
Aug. 11 Federal Register notice – Post-inspection 483 responses
timing policy published – 15 business days
Timely Responses
FDA will conduct “detailed review” in deciding any enforcement action
If FDA issues a warning letter, letter will address sufficiency of response
Late responses
Response will not be considered by FDA in deciding to take enforcement
action such as a warning letter
If warning letter issues after a late 483 response, FDA will consider the 483
response in assessing firm’s later reply to warning letter
Purpose of warning letter: “to ensure that the seriousness and
scope of the violations are understood by top management … and
that the appropriate resources are allocated to fully correct the
violations and prevent their recurrence”
14
15. Enhanced Enforcement – In Action
KV – March 2009 – GMP consent decree four weeks
after inspection
H1N1 Websites – May 2009 -- 68 Warning Letters –
response time shortened to 48 hours due to the public
health aspects
Caraco – June 2009 -- seizure six weeks after inspection
Major import alert – coming – Washington Drug Letter,
8/31/09
15
16. Enhanced Enforcement –
The International Stance
FDA to double foreign GMP inspections
Focus: GMP inspections, not inspections linked to
applications
Result: Look for more import alerts
FDA can impose alert based on just an “appearance” of a violation
Contrast: formal U.S. enforcement such as seizure, injunction or
prosecution, FDA must prove a violation
“FDA Without Borders” Initiative
Offshoot of Heparin and other scandals
FDA foreign offices opened: Brussels; Mumbai; New Delhi;
San Jose, Costa Rica; Beijing, Shanghai and Guangzhou, China
Additional planned FDA offices: Mexico City, Middle East
(site TBD)
16
17. How to Prepare for
The New Enforcement Climate
The Big Picture
Compliance Culture – must exist at the top of your
organization and be driven down by senior management
throughout your firm not only in word, but in resources
FDA law requires – “Park Doctrine” – Strict Liability
Corporate law requires
Public company duties/Sarbanes-Oxley compliance
Best strategy to “avoid” enforcement – strict compliance
via robust “quality systems” in all impacted areas – quality,
regulatory, manufacturing, packaging, testing, etc.
17
18. How to Prepare …
Change Your Corporate Compliance World View
Oust the Reactionary Compliance Model
Historical focus – always after-the-fact
Expense focus creates little incentive for forward thinking
Compliance generally seen as production cost
Rarely seen as a revenue-generating opportunity
Viewed as lower priority within an organization
Perceived as a burden – a leash with little up side potential
Embrace Compliance As a Corporate Asset
Corporate culture must change
Quality Systems must be integrated into the process, not an
additional component
Process must evolve from one of police action to one of
forethought
18
19. How to Prepare …
Culture Change – Dramatic And Difficult
Quality function must be valued by management
Increase visibility of quality unit
Visibly exhibit an intolerance for lack of compliance
Quality must be seen as a priority
Embrace a Proactive Approach
“It is often said at FDA that firms that are in compliance tend
to stay in compliance, but once a firm gets out of compliance
getting back into compliance is a very steep road to climb. Try
to avoid that road.” – Daniel Troy, former FDA Chief Counsel
19
20. How to Prepare …
Build The Right Quality Systems
Create a self-determining culture
Make regulatory mandates obvious and routine, not the focus
Use Quality Assurance as a cost-improvement methodology
Proactive Approach To Increasing Profitability
Approach facilities and operations inspections proactively
Use third parties
Assess all business operations
Act on things immediately
Change focus from compliance to improvement – that
compliance is subset of quality
20
21. How to Prepare …
Detailed view – quality systems throughout your
organization that reflect strong:
Procedures
Training
Audits
Validation
Recordkeeping
Key SOPS
Handling FDA Inspections
CAPA
Investigations
Recalls
Audit Plans
21
22. When FDA Enforcement Hits
How it may hit
Administrative Enforcement
Inspections
Investigations
Warning letter
Clinical Holds – can be compliance-based
AIP
Termination of an IND or IDE
Disqualification procedures with clinical investigators
Recalls and market withdrawals
Civil Money Penalties
Judicial Enforcement
Seizure of test articles
Disgorgement
Injunction
Criminal Prosecution
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23. When FDA Enforcement Hits …
Who FDA Can Target: any individual within the
company that has a position of responsibility for the
violative aspect of the company’s operation,
including:
President/CEO/COO
General Counsel
VP or Director of QA, QC, RA, Mfg., etc.
Managers
Technicians (rare)
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24. When FDA Enforcement Hits – Assessing
Assess each allegation/observation
Focus on specifics
Focus on system-wide implications
Focus on global implications
Consider affected products
Consider root-cause analysis
Focus on the regulatory requirement(s) associated
with each allegation/observation
Develop action plan to achieve immediate, short-term,
and long-term correction and to prevent recurrence
Know when to seek outside assistance
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25. When Enforcement Hits –
Keys to Responding
Include a commitment/statement from senior leadership
Address each allegation/observation separately
State whether you agree or disagree with the
allegation/observation
Provide corrective action accomplished and/or planned;
tell FDA the plan
Be specific (e.g. observation-by-observation)
Be complete
Be realistic
Be able to deliver what you promise
Address affected products
25
26. When Enforcement Hits –
Keys to Responding …
Provide time frames for correction
Describe method of verification and/or monitoring for
corrections
Submitting documentation of corrections where
reasonable & feasible
Be timely and thorough – deliver what you promised
when you promised it
26
27. FDA Expectations for Your Response
Wants to Hear Your D.R.U.M. – expects your
response to have these qualities:
Direct – i.e., address the items directly raised in the 483 or
warning letter
Related – go beyond those to potentially related problems
Universal – expand to review those issues company-wide
Management & Monitoring – show that you will stay on
top of the issues and that management is involved
Source: “Compliance and Enforcement.” Presentation by David K.
Elder, Director, FDA Office of Enforcement, at the Orange County
Regulatory Affairs (OCRA)/FDA Joint Educational Conference. June
15, 2005. Irvine, California.
27
28. Direct Possible Consequences
of Non-Compliance
Clinical holds – study stopped
AIP – application reviews suspended
Import Alerts – product can’t be imported into U.S.
Civil Money Penalties – $$$
Seizures – product can’t be sold
Injunctions – selling/manufacturing could be halted for years
Disgorgement – $$$ returned for “ill-gotten gains”
Prosecutions
Fines – $$$
Imprisonment
Disqualification proceedings
Approval withdrawal proceedings
Expense of dealing with FDA action – lawyers, consultants,
experts 28
29. Collateral Consequences
of Non-Compliance
Financial consequences
Lost sales
Stock price drops – market capitalization – ability to use capital
markets
Shareholders sue the company, its officers and directors
Other companies may sue the company if reason for non-
compliance gave you a competitive edge
Federal government may suspend or “debar” company from
selling to government
“Qui Tam” actions under the False Claims Act – e.g., Lupron &
Neurontin cases – “whistle blower” cases – leading to civil
damages and may also spawn a criminal prosecution
Financing covenants may be violated
29
30. Collateral Consequences of
Non-Compliance …
Other Consequences
State license actions – could pull your manufacturing license
Lay-offs
Damage to corporate reputation
Lost time – interruption with normal operations
Consequences for Individuals
Job loss
Reputation
Expense of defending – and your company may not have to pay
Impact of convictions
Deportation if not U.S. citizen
Imprisonment
Fine
Right to vote/run for public office
30