Transcript Slide 1

CLINICAL RESEARCH
COMPLIANCE
PharmaCongress
Washington, D.C.
Thursday, November 8, 2007
Michael A. Swit, Esq.
Vice President, Life Sciences
ANCIENT CHINESE CURSE
May You Live in Interesting Times …
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THESE ARE INTERESTING
REGULATORY TIMES
• September 30, 2004 – the beginning of the
current era of drug regulation
– Vioxx
– SSRI’s and suicidal ideation
• Since then:
– Tysabri
– Avandia
• New Lynchpin of Regulatory Process –
Drug Safety
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INTERESTING REGULATORY
TIMES …
• FDA Leadership
– Top -- In disarray
• 2004 -- McClellan left to go to CMS; Crawford interim
Commissioner
• Summer 2005 – Crawford confirmed by Senate
• Sept. 2005 – Crawford abruptly resigns
• 2006 – Andrew von Eschenbach becomes acting
• December 2006 – von Eschenbach confirmed
• Sept. 2007 – General Counsel resigns
– Deputies & Associates – many leave at end of 2006
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The Perfect Storm?
• The Current FDA Regulatory Equation -- (Drug Safety
Lynchpin) + (Leadership Vacuums) = an approval process mired
in uncertainty, fear and decision paralysis
PLUS
• A Democratic Congress
PLUS
• September 30, 2007 – Deadline Day
– PDUFA Reauthorization Sunsets
– Pediatric Exclusivity and Pediatric “Rule” Sunsets
EQUALS
• Congress in driver’s seat to drive change??
– But, still have 2 more years of Bush
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KEY FDA CONCERNS SHOULD
INFORM YOU
• Informed Consent Handling
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Timing issues (enrollment before IC)
Wrong forms (e.g., different study)
Total absence of informed consent
Person doing consent not trained on process
L.A.R. handling
Translations
Exculpatory language
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KEY FDA CONCERNS …
• Absence of an IND (Johns Hopkins)
• AE Handling
– Not reported to IRB
– Not reported to FDA
• Protocol deviations
– Dosage
– Timing of events
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FDA Audits at the Sponsor
• To measure compliance with GCP, FDA audits
sponsors’ SOPs for
– informed consent
– protocol preparation
– adverse experience reporting
– data entry and compilation
– recordkeeping
– site monitoring
• CRO’s – ride herd on them
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FDA -- Site Inspection Concerns
• Site Qualification -- how (e.g., telephone, memo, etc.)
the monitor explained to investigator status of the test
article, nature of the protocol, and the obligations of a
clinical investigator
• Delegation of Authority -- 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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FDA -- Site Inspection Concerns
• 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 are
up to date
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Protocol Changes
• 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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Other Key Concerns
• Clinical Sites –
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source document handling
Completeness of Patient Records
Signature logs
Test article accountability
Record retention
• IRB Matters –
– continuing review
– Expedited review
• Data integrity – Fraud –
– AIP
– Investigator disqualification
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Downstream Damage – Collateral
Consequences
• NDA denial
• FDA administrative or legal actions (seizure,
injunction, criminal prosecution)
• Products liability exposure
• Shareholder litigation
• Etc., etc., etc.
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Final Sermon:
Please Teach Vigorous Corporate Risk
Avoidance
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P = Procedures
T = Training
V = Validated
C = Compliance Culture from the Top
R = Records
A = Audit
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Questions?
Call, e-mail, fax or write:
Michael A. Swit, Esq.
Vice President, Life Sciences
THE WEINBERG GROUP INC.
336 North Coast Hwy. 101
Suite C
Encinitas, CA 92024
Phone 760.633.3343
Fax 760.633.3501
Cell 760.815.4762
D.C. Office 202.730.4123
[email protected]
www.weinberggroup.com
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About your speaker…
Michael A. Swit, Esq., is Vice President, Life Sciences 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 and CMS 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.
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For more than twenty years, leading companies have depended on THE
WEINBERG GROUP when their products are at risk. Our
technical, scientific and regulatory experts deliver the crucial results
that get products to market and keep them there.
Washington, D.C. ♦ San Francisco ♦ Brussels ♦ Edinburgh
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