michael a. swit, esq. fda enforcement what every clinical director should know june 15, 2003 drug...
TRANSCRIPT
FDA Enforcement What Every Clinical
Director Should Know
June 15, 2003Drug Information Association
Annual Meeting
Michael A. Swit, Esq.Michael A. Swit, Esq.
Law Offices of Michael A. [email protected]
FDACounsel.com
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Workshop – Our Organization/ObjectivesI. FDA Enforcement Concerns for the Clinical Director Good Clinical Practice (GCP)
From the Investigator’s, IRB’s, CRO’s and Sponsor’s vantage points
Application/data integrity policy electronic records/signatures financial disclosure
Pre and Post-approval activities (adverse reaction reporting, advertising based on clinical studies data)
BREAK
II. FDA Administrative Enforcement ToolsIII. Civil and Criminal PenaltiesIV. Collateral Damage – Worst Case Scenarios from Clinical Studies
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Enforcement is Related to FDA’s Mission products are safe and effective honest, accurate, informative
representation of products correction of noncompliance or
removal of unsafe or unlawful products
Human subject protection is a goal shared with HHS’s OHRP
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I. FDA Enforcement: GCP
With any compliance plan, it is not the volume of your SOPs, but their overall effect
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GCP: Informed Consent FDA and NIH Oversight overlap of authority on informed consent
sometimes complicates the issues Example: FDA proposal (ANPRM) to
prevent IRB "shopping" more patients would be willing to participate
in clinical trials if they knew of the protections which would apply to them (“Will & Why Survey”, 2001)
HIPAA: medical records privacy enforcement by HHS/OCR
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HHS: Research Subject Protection HHS Office of Human Research Protections HHS authority is based on academic
sponsorship, where increasingly it is the “academic-industrial” complex
future unification of patient protection under FDA – possible, but not imminent; to contrary, may see more exercise of its resources by OHRP
identified need for more resources for IRBs IRBs have been seeking new revenue sources
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Learning From FDA’s Most Recent
Warning Letters to Investigators --
No geographic concentration: they are issued from district offices all over the country
CDER, CBER and CDRH are all active Reputation and compliance don’t
always go together The specificity of detailing violations: no
compliance detail is too small
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Learning From FDA’s Most Recent Warning Letters to Investigators …
Warning Letters can be issued much later than the 483 and adverse publicity
Lots of money is spent on legal fees during the enforcement process: avoidance is your best policy!
Foreign clinical sites are not immune
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Johns Hopkins University: June 2001
FDA Inspection followed report of death of a healthy volunteer who had inhaled hexamethonium
FDA’s 483 to the IRB (September 2001) cites: failure to obtain effective informed
consents: failure to disclose that inhalation administration of the drug was experimental
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Johns Hopkins University: June 2001 …
failure of clinical investigator to submit an IND prior to conducting the investigation (3 subjects)
changes to IRB approved protocol without notifying the IRB (and without IRB approval)
Warning Letter Issued March 31, 2003 to Investigator failure to report an unanticipated AE to the
IRB Note: time interval between incidents and Warning
Letter – unusual, but not unprecedented.
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Recent warning letters:Informed Consent
Failure to obtain informed consent in accordance with the provisions of 21 CFR Part 50. [21 CFR Part 312.60]
There are no consent forms for two subjects, three consent forms were signed after the test article was administered, and one subject signed the wrong consent form as follows:
• no informed consent forms for certain patients
• Signed the wrong consent form (different study)
• Signed the informed consent form over four months after the test article was administered
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More Lessons from Recent Warning Letters …
If protocol requires patient to complete a diary card during 5 days from pre-screening and screening visits, they CANNOT be pre-screened and screened on the SAME day
“Your (investigator’s) response indicates that you were not aware of the deviations in study drug dosage and administration due to the blinded nature of the study randomizations. Nevertheless, as the clinical investigator, you are ultimately responsible for the pharmacy staff.”
Investigator submitted incorrect data to sponsor
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GCP: Other Areas of FDA Enforcement Priority BIMO: Bioresearch Monitoring responsible for inspecting clinical sites and
sponsors’ facilities to compare data gathered during clinical studies with data held by sponsors
FDA CPG MANUAL Chapter 48 http://www.fda.gov/ora/compliance_ref/cpg/
Inspection of foreign clinical sites occur when the studies covered provide data
critical to product approval regardless of whether the studies are conducted under an FDA application for research
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GCP: SOP Auditing
To measure compliance with GCP, FDA audits sponsors’ SOPs informed consent protocol preparation adverse experience reporting data entry and compilation recordkeeping
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Specific GCPs That FDA Will Review When Inspecting a Clinical Site
how (e.g., telephone, memo, etc.) the monitor explained to the clinical investigator the status of the test article, nature of the protocol, and the obligations of a clinical investigator
whether authority for the conduct of the various aspects of the study was delegated properly so that the investigator retained control and knowledge of the study
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Specific GCPs That FDA Will Review When Inspecting a Clinical Site
if and why the investigator discontinued the study before completion
if laboratory tests are performed in the investigator’s own facility, whether that facility is equipped/staffed to perform each test specified (example: CLIA high complexity certification)
protocol and all IRB approvals and modifications
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Protocol Amendments Must Be Up to Date
subject selection (i.e., inclusion and exclusion criteria)
number of subjects
frequency of subject observations
dosage, frequency
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Protocol Amendments Must Be Up to Date
all changes to protocol must be: documented by an approved amendment
(and may need FDA pre-clearance under IND rules)
dated maintained with the protocol approved by the IRB and reported to the
sponsor before implementation, except where necessary to eliminate apparent immediate hazard to human subjects
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GCP: Clinical Site Source Documents
FDA’s right to inspect must be in informed consent organization, condition, completeness, and legibility of
source documents adequate documentation to assure all audited subjects did
exist and were alive and available for the duration of their stated participation in the study
comparison of source documents in the clinical investigator’s records with CRFs completed for the sponsor
presence of completed clinical laboratory testing (including EKGs, X-rays, eye exams, etc.)
whether all AEs were reported in the CRFs
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GCP: Completeness of Patient RecordsEach patient record must contain: observations, information, and data on the condition
of the subject at time subject entered clinical study AND records of exposure of subject to the test article
observations and data on condition of subject throughout investigation, including results of lab tests, development of unrelated illnesses, and other factors that might alter effects of the test article; and
signature log: identity of all persons and locations obtaining raw data or involved in the collection or analysis of such data
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GCP: IRB Matters
Identify and chairperson of the IRB investigator must maintains copies of all reports
submitted to the IRB and reports of all actions by the IRB
nature and frequency of periodic reports submitted to the IRB
investigator must submit a report to the IRB of all deaths, adverse experiences and unanticipated problems involving risk to human subjects
Did the investigator submit to and obtain IRB approval of the following before subjects were allowed to participate in the investigation?
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GCP: Patient/Subject Recruitment
Use of media advertising any promotional material or representation that
the test article is safe and effective for the purpose for which it is under investigation is violative
all promotional materials must be submitted to the IRB for review and approval before use
Payment of enrollment bonus
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GCP: Test Article Accountability
What is the date the last subject completed the study?Were test articles returned when either: The investigator discontinued or completed
his/her participation; The sponsor discontinued or terminated
the investigation; or The FDA terminated the investigation.
Unqualified or unauthorized persons may not administer or dispense the test article
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Another Warning Letter: Failure to maintain control of the investigational drug [21 CFR 312.61]
“[name] released the test article to a physician not listed on the Form FDA 1572 at another local hospital on 2/13/99 for use on an individual not enrolled in the study. This demonstrates lack of adequate training by the sponsor.”
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GCP: Records Retention
Identification of custodian of required records and means for prompt access
Period of Retention Two years following the date on which the test
article is approved by FDA for marketing for the purposes which were the subject of the clinical investigation; or
Two years following the date on which the entire clinical investigation (not just the investigator’s part in it) is terminated or discontinued by the sponsor
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Electronic Records and Signatures
Applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirement set forth in agency regulations
Points to Consider: source of the hardware person(s) responsible for installation and training source of data entered into the computer
Direct (no paper) Case report form Office record
authority to enter/modify data
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Recent GCP Developments
Proposed Rule (3/14/03) to adopt ICH standards for pre- and post-marketing safety reporting
Changes to Part 11 Approach (Electronic Records and Signatures)
Draft Guidances: Clinical Hold Authority for Investigator Misconduct (8/02)
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Coming Soon?
Institutional IRB Review of Research Conducted at Other Sites
Acceptance of Clinical Studies Conducted Outside the U.S.
Charging for Investigational Products Recruiting Study Subjects Payments to Research Subjects Use of Investigational Products When
Subjects Enter a Second Institution
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Current FDA Enforcement Priorities: Application/Data Integrity Policy
The AIP applies to any application (e.g., NDA, BLA, PMA), amendment, supplement, petition, or other submission in support of the approval or marketing of a regulated product
Does not apply only to data tainted or possibly tainted by fraud or other intentional misconduct
“Data may not be unreliable due to sloppiness and inadvertent errors. A pattern of errors by an applicant involving material subject matter may raise a significant question regarding the general reliability of data in applications from that applicant.”
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AIP: History
formerly known as the “Fraud” Policy developed and implemented in response to generic
drug scandal of 1980s Dozens of generic company officials and employees
indicted and convicted of crimes including: making false statements, conspiracy to defraud FDA, obstruction of justice (including obstructing an FDA inspection), and introducing adulterated and misbranded drugs
Criminal fines of $10,000,000 imposed on one company; a number of officials and employees were incarcerated as well as fined
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AIP if FDA has significant questions
surrounding the reliability of the data in an application, it will defer substantive scientific review of all the data in the application - and, possibly, other applications
deferral will continue until all questions regarding the reliability of the data have been resolved
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AIP: Managed Through Corporate Internal Audit and Action Plan
Importance of monitoring and QC visits
Clean up clinical sites before making a submission to FDA
Lessons Select investigators with great care Don’t skimp on GCP compliance
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BioCryst Pharmaceuticals UAB/BioCryst had close financial ties University’s competing objectives of
advancing science and making money can threaten integrity of medical research
research nurse differed with PI on findings and recorded data which would demonstrate a positive finding for the study vehicle
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BioCryst Pharmaceuticals … PI’s breach of duty falsified results: claimed 60% efficacy,
when really only 30% June 1995: company issued press
release claiming “reanalysis of the data”, did not reveal fraud to FDA until FDA found it on its own inspection in December 1995, which proceeded to criminal investigation
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BioCryst Case Study two convictions of defrauding FDA UAB dermatologist banned from testing drugs for
the FDA (permanent loss of previous nationwide reputation)
NIH suspended university enrollment of patients in 550 studies in 2000, when it became clear that patient rights were also at stake
study coordinator and his wife, the research nurse, at trial in 2000, were found guilty by jury of conspiracy and sentenced to 3 years in prison each; currently on appeal
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FINANCIAL CERTIFICATION/ DISCLOSURE BY SPONSORS AND CLINICAL INVESTIGATORS
“no conflict, no interest” - University researcher
while some institutions flat out prohibit financial conflicts of interest, others permit their “management” - stock in escrow, disclosure to patients and in publications
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FINANCIAL DISCLOSURE BY SPONSORS AND CLINICAL INVESTIGATORS
21 C.F.R. Part 54 (applicable since 1999) sponsors of a marketing application must
submit information concerning certain compensation to, and certain financial interests of, any clinical investigators or subinvestigators (including spouses and dependent children) conducting certain clinical studies to support the application
March 20, 2001 Guidance Document from FDA clarifies disclosable financial interests, covered clinical studies, use of Forms 3454/3455
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To Whom Does The Rule Apply? Investigators and subinvestigators and
their family members (aggregated interests)
March 2001 Guidance specifically exempts “nurses, residents, or fellows and office staff who provide ancillary or intermittent care but who do not make direct and significant contribution to the data”
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Financial Integrity – via Disclosure?? Five types of compensation and rights (collectively
“Interests”) are the primary focus of the regulation Direct payments of more than $25,000. excludes the costs for the conduct of clinical
studies includes honoraria, grants to fund ongoing
research, compensation for or in the form of equipment or services, or retainers for ongoing consultation
disclosure (for all interests) must be made during the “covered” clinical trial and for one year following completion of the trial
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FINANCIAL DISCLOSURE …
Equity interest of more than $50,000 in a publicly traded company
Ownership interest, stock, stock option or other financial interest, no matter how small, the value of which cannot be readily determined through reference to public prices, (e.g., any privately held company or unlisted equity interests)
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FINANCIAL DISCLOSURE …
Proprietary interest in the investigational product including, but not limited to, patents,
copyrights, trade secrets, and licenses Financial arrangements under which
the compensation (e.g., money, equity interest, royalty interest) could be higher for a favorable trial outcome than for an unfavorable trial outcome
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FINANCIAL DISCLOSURE …
Interests are evaluated for disclosure on a “per investigator” basis
Interests of an investigator include the Interests held or received by an investigator and his/her spouse and dependent children, and are aggregated
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FINANCIAL DISCLOSURE …
“covered study” is a trial that FDA or the sponsor relies on to establish that the tested product is effective OR
a study in which a single investigator makes a significant contribution to the demonstration of safety
FDA is particularly concerned with Phase II and III trials (efficacy) and bioequivalence studies where results obtained by a single investigator can have a profound statistical effect on trial outcome
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FINANCIAL DISCLOSURE …
In general, large open-label studies conducted at multiple sites, treatment protocols, Phase I tolerance studies, pharmacokinetic studies, and most clinical pharmacology studies are not “covered” studies
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FINANCIAL DISCLOSURE BY SPONSORS AND CLINICAL INVESTIGATORS
Compliance with financial disclosure/ certification should be part of the clinical investigator selection process and be documented in compliance with regulations
Clinical study agreements should contain provisions requiring disclosure of Interests or a certification that there is nothing to disclose
CRO agreements should obligate the CRO to obtain disclosure/ certification
All clinical study agreements should include the right to obtain a one-year post study update regarding interests – and define, up front, when study ends!!
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FINANCIAL DISCLOSURE
Licensing agreements with clinical investigators on a new investigational product should now contain a clause that requires them to comply with disclosure/certification requirements if their clinical data will be pivotal or relied upon in any subsequent marketing application
Establish and maintain a company-wide tracking system for investigators to enable the company to verify and substantiate its disclosures
Establish and implement procedures for the types of Interests held by investigators and how such Interests will be managed
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II. FDA Administrative Enforcement Tools Each FDA Center has its own Office
of Compliance (OC) OC works with Office of Chief
Counsel and Department of Justicebut, before they haul you into court …
Administrative Enforcement Tools
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Administrative Enforcement Tools Inspections
Planned and conducted pursuant to FDA annual plan or center compliance program
Pre-approval “For cause” (e.g., public health crisis due to
defective or contaminated FDA-regulated product; follow up to 483 response)
Government-wide Quality Assurance Program
FDA may inspect at the request of the DoD or VA to determine, for example, whether a company bidding on a government contract is in compliance with GMPs and otherwise in compliance with the FDCA
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Administrative Enforcement Tools …
Inspections (continued) Combination or joint inspections (EPA, OSHA,
or a state food and drug regulatory body) Consumer, trade, and other complaints Adverse product effect reports Congressionally inspired
Clinical hold Withdrawal or suspension of marketing permit Recall (FDA-requested or “voluntary”)
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More FDA Administrative Enforcement Tools …
Import detention or refusal Civil money penalties Warning Letters
addressed to CEOs/other executives; FDA’s effort to get executive buy-in on necessary fixes is often sabotaged by corporate bureaucracy, which sends the letter back down to the person with knowledge of the specifics
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The Pen Is Mightier Than The Sword: Adverse Publicity FDA Website Press release Talk paper Press conference/television and radio
interview Speeches Congressional and other testimony Articles in scientific, professional and lay
publications
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FDA Inspections (the Source of Most Enforcement Activity):How to Prepare for an Inspection
Know the training and tactics of FDA Investigators Inspection Operations Manual (IOM)
www.fda.gov/ora/inspect_ref/iom see how FDA approaches inspections
Compliance Program Guidance Manual
Other Guidance DocumentsFDACounsel.com
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Preparing for an Inspection
Have a written corporate policy for FDA inspections
Conduct independent audits and internal audits
Establish attitude of the company Designate an inspection
coordinator
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Training Personnel for Inspections
Every employee must know his/her job function and regulatory obligations
Document employee credentials, training and knowledge Study, manufacturing and other protocols QA/QC, GCP documentation FDA program and inspection guidance
documents
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Corporate Inspection Policy & Procedures Address GCP, GMP, GLP and other types of
inspections/inquiries Designate Who will interact with Investigator
Inspection Coordinator and Inspection Group Clinical Director Study Coordinator/Principal
Investigator Production Employees Receptionist/Secretary
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Inspection of Records
What records will be made available Have specific policies on:
photographs tape recorders copying records (shipping, financial
and business records) Questioning of personnel, sampling,
affidavits
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FDA Investigative Techniques for Gathering Evidence
Questioning employees at home at night or on the weekend
permitted under FDCA Sec. 704 can go through trash, obtain grand
jury subpoenas and search warrants for telephone and business records
collaboration with FBI (more on OCI later)
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Home Interviews US v. Ortho Pharmaceutical Corp. Jan. 1995 Ortho paid $7.5M under plea
arrangement for criminal “obstruction of justice” charge
Ortho had ordered the destruction of corporate documents pertinent to an FDA investigation of promotion of Retin-A for unapproved use; destruction began after 2 home visits by FDA inspectors
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HOME INTERVIEWS … Prepare employees to contact company
legal counsel before speaking with an investigator (this assures no waiver or corporate privilege or disclosure of confidential information)
company SOP should reflect desire to cooperate with FDA to the extent that company understands the purpose of the investigation and will not waive or jeopardize its or its employees legal rights
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Personnel Interacting With Inspector(s) Receptionist/Secretary should confirm that
they are at correct name and institution, record inspector’s badge number
never leave investigator unattended receptionist should have list of inspection
coordinator and alternate persons: Clinical Director / Study Coordinator / Principal
Investigator Production V.P. / Quality Control Manager Executive V.P. / President Legal Counsel
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Duties of Inspection Coordinator
Examine Credentials and 482 Forms Ask What Type of Inspection Write down all pertinent information
contact core group work out inspection agenda inform investigator of corporate policies
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General Tactics During Investigation
Designate a Conference Room Never Speculate on an Answer Don’t Allow Access to Areas Beyond Scope
of Inspection under § 704 You get the items if needed
Never Mislead the Investigator Don’t Panic (i.e., missing documents,
questions)
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Defensive Strategies During/After Inspection to Avoid Enforcement
draw the investigator into a conversation when a problem is identified: more details (so that I may investigate); how/why is what we are doing (apparently)
inadequate (so I may explain to management)
Written response to 483: Show the likelihood of recurrence of the
problem/violation is low Show the company is doing all it can reasonably to
remedy the situation: specific steps, timetable, monitoring
problems attributable to a specific cause have/will be fixed with permanent remedies
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More Defensive Strategies provide specific evidence to minimize public
health risk number/scope of product’s distribution ability to do stock recall technical assessment
if it follows product recall, note that company was “on the ball” and caught the problem, as it was supposed to; foreclosing greater risk
if not, what changes are being made to catch sentinel events/data in the future
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Post-Inspection Debriefing
Exit Interview 483 Observations Ask For:
Explanation and Details Examples
Write Down Exactly What Investigator Says
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483/EIR: Inspection Results
NAI - No objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action)
VAI - Objectionable conditions or practices were found, but the District is not prepared to take or recommend any administrative or regulatory action
OAI - Regulatory and/or Administrative actions will be recommended
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Disagreements with 483 Observations Make notes of your requested comments
and include them in your 483 response Never argue with inspector Never make verbal promises, only written
responses Affidavits
Never sign them and don’t even listen to a reading
If they push, ask them to send to your attorney for review
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Written Response to the 483
Address each observation separately Never agree that an observation is
valid: instead, state changes you intend to make
Disagreements: Present your argument Be responsive, not argumentative
Attach copies of changed documents
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Enforcement Options Based on Inspectional Violations
Warning letter termination of the IND or IDE initiation of disqualification procedures or entry into
a consent agreement with the clinical investigator disqualification of the investigator simultaneous to
criminal prosecution. initiation of stock recovery by sponsor seizure of test articles injunction prosecution under the FDCA
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FDA Enforcement Discretion
Prior History of Company’s Compliance prior 483’s, warning letters, and
company’s response Health risks Likelihood of recurrence
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III. FDA Civil and Criminal Enforcement Tools Criminal prosecution - Title 18
§ 371 (conspiracy) § 1001 (false statements) § 1341,43(mail and wire fraud) § § 1505, 1509-10 (obstruction) § 1962 (RICO)
imprisonment Seizure and destruction of product Import detention Injunctions Fines/Disgorgement Consent Decrees
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Criminal Prosecution: Misdemeanors
Misdemeanor Strictly liability (no criminal intent
necessary) Fines up to $100,000 and $200,000 per
misdemeanor offense for an individual and a corporation respectively ($250,000 and $500,000 if the misdemeanor offense resulted in death)
Imprisonment
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What Can FDA Target In An Enforcement Action?
Scope of Enforcement Action Can Be Very Broad:
all areas where FDA perceives violations, and responsible persons involved in such violations
labeling, promotion, manufacturing, QA, distribution, regulatory affairs, quality control
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Who Can FDA Target During An Enforcement Action
Any and all individuals within the company that have a position of responsibility for the violative aspect of the company’s operation, including:
President/CEO/COOProduction ManagerVP or Director of Quality ControlDirector of Regulatory AffairsDirector of Quality AssuranceTechnicians
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Bard (1993): Not only Executives are Charged Director for Regulatory Affairs and a supervisor in the
R.A. Department among those charged 3 executives convicted of defrauding FDA, but
vacated in March 2001 on appeal based on improper instructions to jury by judge
June 2001 -- the 3 defendants settled and pleaded to misdemeanor charges in shipment of adulterated heart catheters: one year of probation and 8 months of in-home confinement; Bard paid $61M
as with tax law, misunderstanding of FDA law may be a legitimate defense; given complexity of regulatory law, you can violate innocently
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Disgorgement FDA recovery of company profits can’t profit from sales of an illegal product that
is nonetheless medically necessary FDA refrains from enjoining production of non-
compliant products because it would compromise patient care by causing significant shortages of medically necessary products
in return, firms will pay a fixed % of future sales to ensure that they did not profit from the violative products
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CONSENT DECREE Order of a court entered by consent of the parties not technically a judicial sentence, but a
negotiated contract between the parties under the sanction of the court
parties represent that it is a just determination of their rights as if the alleged facts of the case had been proven
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CONSENT DECREES … How do they come about?? Settlement of a court case after FDA has
filed for an injunction voluntary negotiations with FDA after an
adverse inspection Most terms/conditions negotiable -- but
depends on your leverage point companies more often concerned about
naming executives as individually responsible: FDA finds this point important as a deterrent and necessary to pursue contempt charges if decree becomes ineffective
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Duty of Care Corporate directors can in turn be personally
liable for losses incurred because of corporate failure to meet legal compliance standards
McCall (2001): Columbia/HCA shareholder derivative action against board members;
directors lose protection of “business judgment” rule and are personally liable for failure to detect and correct violations
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DUTY OF CARE … board’s duty of care breached through
nonfeasance: failure to investigate items from internal audit
if you are subject to a search warrant at one site, begin internal investigation at all sites to see whether similar violative practices exist (otherwise breaches duty of care)
need to investigate whistleblower cases, no matter how frivolous they appear
Under FDCA – strict liability – U.S. v. Park
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IV. Collateral Damage – Worst Case Scenarios from Clinical Studies
This is a picture you do not want to see …. in your newspaper …. on your local news …. on the Internet ….
or in a DIA presentation for years to
come ….
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Ex-Imclone CEO exits federal court after being charged with nine felony counts
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“Does Crime Pay?” – Problems Beyond Jail and Fines
PROBLEMS FORINDIVIDUALS IFCONVICTED: Lose right to vote Lose right to run for
public office Damage to
reputation
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“Does Crime Pay?” -- Problems Beyond Jail and Fines (cont’d ...)
PROBLEMS FORINDIVIDUALS IFCONVICTED (cont’d): Can be deported if
not a U.S. citizen Financial ruin - -
lose your job
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“Does Crime Pay?” -- Problems Beyond Jail and Fines (cont’d ...)
PROBLEMS FOR COMPANIES CAUSED BY CRIMINAL CONVICTIONS: Shareholders sue the company, its officers
and directors Other companies may sue the company
(e.g., Mylan Labs sued Par and others) Federal government may suspend or
“debar” company from selling to government “Qui Tam” actions under the False Claims
Act -- e.g., Lifescan case -- “whistle blower” cases -- leading to civil damages and may also spawn a criminal prosecution
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“Does Crime Pay?” -- Problems Beyond Jail and Fines (cont’d ...)
PROBLEMS FOR COMPANIES CAUSED BY CRIMINAL CONVICTIONS (cont’d):
FDA may refuse to approve ANDAs
May lose state licenses
Customers abandon you
Decreased sales may force lay-offs of employees
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“Does Crime Pay?” -- Problems Beyond Jail and Fines (cont’d ...)
PROBLEMS FOR COMPANIES CAUSED BY CRIMINAL CONVICTIONS (con’d): Financing disappears -- banks may
refuse to lend money May violate lending agreements, real
estate mortgages or leases A criminal investigation can cause great
disruption to normal business activities
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“Does Crime Pay?” -- Problems Beyond Jail and Fines (cont’d ...)
PROBLEMS FOR COMPANIES CAUSED BY CRIMINAL CONVICTIONS (con’d): High cost in money of an investigation:
– lost sales
– stock price falls
– attorney’s fees and costs
– costs of complying with requests by government for documents
The End
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THANKS !!! To Monika Chas, formerly of Par
Pharmaceutical’s Regulatory Affairs Department, for drawing the illustrations in this presentation.
To Michelle Viña, formerly of Par Pharmaceutical’s M.I.S. Department, for getting Monika’s drawings imported into the software program so they could be printed years ago when no one knew how to do it.
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Questions?
Call, e-mail, fax or write:
Michael A. Swit, Esq.Law Offices of Michael A. Swit
539 Samuel Ct., Suite 229Encinitas, California 92024
760-815-4762 ♦ 760-454-2979 (fax)[email protected]
http://www.fdacounsel.com
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About the speaker ...
Michael A. Swit has extensive experience in all aspects of FDA regulation with a particular emphasis on drugs and medical device regulation. In addition to his regulatory law experience, Mr. Swit also served for three and a half years as vice president and general counsel of Pharmaceutical Resources, Inc. (PRI) a prominent generic drug company and, thus, brings an industry and commercial perspective to his representation of FDA-regulated companies. While at PRI from 1990 to late 1993, Mr. Swit spearheaded the company’s defense of multiple grand jury investigations, other federal and state proceedings, and securities litigation stemming from the acts of prior management. Mr. Swit then served from 1994 to 1998 as CEO of Washington Business Information, Inc. (WBII) a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA publishing company. Before starting FDACounsel.com, he was with Heller Ehrman from May 2001 to May 2003, and also twice in private practice with McKenna & Cuneo, from 1988 to 1990 and, most recently, from 1999 to 2001, first in that firm’s D.C. office and most recently, in its San Diego office. He first practiced FDA regulatory law with the D.C. office of Burditt & Radzius from 1984 to 1988. Mr. Swit has taught and written on a wide variety of subjects relating to FDA law including, since 1989, co-directing a three-day intensive course on the generic drug approval process, serving on the Editorial Board of the Food & Drug Law Journal, and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved, published by WBII. Mr. Swit holds an A.B., magna cum laude, with high honors in history, in 1979, from Bowdoin College, and earned his law degree from Emory University in 1982. He is a member of the California, Virginia and District of Columbia bars.
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