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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
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
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
Enforcement Trends Prior to
Obama Administration
4
All Inspections – 2004 to 2008
5
Warning Letters – 2004 to 2008
6
Seizures – 2004 to 2008
7
Injunctions – 2004 to 2008
8
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
 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
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
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
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
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
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
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
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
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
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
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
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
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
22
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)
23
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
24
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
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
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
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
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
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
Q&A
Please complete our Evaluation/Survey
31

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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
  • 4. Enforcement Trends Prior to Obama Administration 4
  • 5. All Inspections – 2004 to 2008 5
  • 6. Warning Letters – 2004 to 2008 6
  • 7. Seizures – 2004 to 2008 7
  • 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 22
  • 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) 23
  • 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 24
  • 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
  • 31. Q&A Please complete our Evaluation/Survey 31