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MAGI’s Clinical Research Conference - 2009 West
Michael A. Swit, Esq., Vice President
October 6, 2009San Diego, California
FDA Inspections: Handling the ConsequencesDealing with the aftermath of an FDA inspection.
Standard Disclaimers
Views expressed here are solely mine and do not reflect those of my firm or any of its clients.
This presentation supports an oral briefing and should not be relied upon solely on its own to support any conclusion of law or fact.
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
Enforcement Trends Prior toObama Administration
All Inspections – 2004 to 2008
Warning Letters – 2004 to 2008
Seizures – 2004 to 2008
Injunctions – 2004 to 2008
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
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
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
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
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
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”
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
Apotex – Sept. 2009 – import alert blocks all products from two facilities
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.
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
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
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
How to Prepare … Detailed view – quality systems throughout your
organization that reflect strong: Procedures Training Audits Validation Recordkeeping
Key SOPS – Clinical Research Setting Handling FDA Inspections Informed Consent IRB Interaction AER Handling Protocol Changes IND/IDE Maintenance Site Monitoring Clinical Trial Registry compliance Clinical Supply Handling
When FDA Enforcement Hits How It May Hit In Clinical Research
Setting Administrative Enforcement
Inspections Investigations Warning letter Clinical Holds – can be compliance based AIP Termination of an IND or IDE Disqualification procedures with clinical investigators Civil Money Penalties
Judicial Enforcement Injunction Criminal Prosecution
When FDA Enforcement Hits …
Who FDA Can Target: any individual within the organization that has a position of responsibility for the violative aspect of the company’s operation, including:
Clinical InvestigatorsResearch coordinators/nursesIRBs/IRB members
When FDA Enforcement Hits -- Assessing
Assess each allegation/observation Focus on specifics Focus on system-wide implications Focus on global implications Consider affected products – should investigation
continue? 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
When Enforcement Hits – Keys to Responding
Include a commitment/statement from senior leadership
Address each allegation/observation separately Be discreet in deciding to agree or disagree with the
allegation/observation – focus on facts do not admit to violations
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
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
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 involvedSource: “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.
Direct Possible Consequences of Non-Compliance
Clinical holds – study stopped AIP – application reviews suspended Civil Money Penalties -- $$$ Injunctions – selling/manufacturing could be
halted for years Prosecutions
Fines -- $$$ Imprisonment
Disqualification proceedings Approval withdrawal proceedings Expense of dealing with FDA action – lawyers,
consultants, experts
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 Financing covenants may be violated
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
Call, e-mail, fax or write:
Michael A. Swit, Esq.Vice President
The Weinberg Group Inc.336 North Coast Hwy. 101
Suite CEncinitas, CA 92024
Phone 760.633.3343Fax 760.454.2979Cell 760.815.4762
Questions?
About your speaker…Michael A. Swit, Esq., is a Vice President at THE WEINBERG GROUP, where he develops and ensures the execution of a broad array of regulatory and other services to drug and biologics clients seeking to market products in the United States. His expertise includes FDA development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts.
Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. His multi-faceted experience includes serving for three and a half years as corporate vice president, general counsel and secretary of Par Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and commercial perspective to his work with FDA-regulated companies. Mr. Swit then served for over four years as CEO of FDANews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA-regulated community. His private FDA regulatory law practice has included service as Special Counsel in the FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe and with the Food & Drug Law practice at McKenna & Cuneo, both in the firm’s Washington office and later in San Diego. He first practiced FDA regulatory law with the D.C. office of Burditt & Radzius.
Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the Food & Drug Law Journal Editorial Board, he also has been a prominent speaker at numerous conferences sponsored by such organizations as RAPS, FDLI, and DIA. A magna cum laude graduate of Bowdoin College, he received his law degree from Emory University Law School and is a member of the California, D.C. and Virginia bars.
