This document summarizes the FDA's Application Integrity Policy (AIP), which was established in 1991 in response to fraud in generic drug applications. The AIP allows the FDA to defer review of any application where they have questions about the reliability of the data, until those questions are resolved. Companies that fall under the AIP must cooperate with investigators, identify wrongdoers, conduct an internal review, and submit a corrective action plan signed by the CEO to address procedures and controls to prevent future issues. Few companies have survived being placed on the AIP, as it often coincides with criminal prosecution and civil litigation that can damage a company.

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The Application Integrity Policy (AIP):
A Little History
Michael A. Swit, Esq.
Vice President, Life Sciences
Presentation to the Food & Drug Law Institute
Annual Enforcement, Litigation & Compliance
Conference for the Drug, Device, Food,
and Tobacco Industries
December 6, 2017
Washington, D.C.

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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.
• These slides are intended to provide general
educational information and are not intended to
convey legal advice.

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APPLICATION INTEGRITY POLICY (AIP)
• Spawned by the Generic Drug Scandal
• Dyazide Switch
• Maxzide Switch
• Formerly known as the “Alert List”
• Formally announced – September 10, 1991
• 56 Fed. Reg. 46191
• See also -- Compliance Policy Guide (CPG) 7150.09/aka
CPG Sec. 120.200 – “Fraud, Untrue Statements of
Material Facts, Bribery, and Illegal Gratuities”
(https://www.fda.gov/ICECI/ComplianceManuals/Co
mpliancePolicyGuidanceManual/ucm073837.htm)

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AIP
• Triggers -- “actions subverting FDA process,” such as:
• Fraud in applications or other falsifications
• Bribery or gratuities
• 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
• Will need to resubmit new application to fix tainted
application

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• Corrective Action Plan -- what you need to do if fall
under AIP:
– Cooperate fully with FDA and other federal investigators
– Identify all wrongdoers and remove them from authority
– Conduct an internal review with outside consultants to uncover
all other wrongdoing
– Written action plan to assure safety, effectiveness, and quality
of products, signed by your CEO
• Procedures and controls to preclude in future
• Ethics programs
• FDA Verification -- reinspection
FDACounsel.com5
AIP …

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Impact of AIP
• Only a handful of companies have survived being
on the AIP
– those that did, typically were on it for at least 4 years
– usually goes hand-in-hand with:
• criminal prosecution of companies and individuals
• collateral civil litigation, such as:
– suits by competitors
– securities litigation
– shareholder derivatives action
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Questions?
 Call, e-mail or write:
Michael A. Swit, Esq.
LAW OFFICES OF MICHAEL A. SWIT
San Diego, California 92130
m: 760-815-4762
e: mswit@fdacounsel.com
web: www.fdacounsel.com
 Follow me on:
– LinkedIn: http://www.linkedin.com/in/michaelswit
– Twitter: https://twitter.com/FDACounsel

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About Your Speaker
Michael A. Swit, Esq., has been addressing critical FDA legal and regulatory issues for over 30
years. Before returning to his private law practice in late 2017, he served for 3 years as the chief
regulatory counsel at Illumina, Inc., the world’s leading developer of gene sequencing technologies.
Prior to that, Swit was a special counsel in the FDA Law Practice at the global law firm of
Duane Morris LLP, in its San Diego office. Before joining Duane Morris in March 2012, Swit served
for seven years as a vice president at The Weinberg Group Inc., a preeminent scientific and
regulatory consulting firm in the Life Sciences.
His expertise includes product development, compliance and enforcement, recalls and crisis
management, submissions and related traditional FDA regulatory activities, labeling and advertising,
and clinical research efforts for all types of life sciences companies, with a particular emphasis on
drugs, biologics, therapeutic biotech products, medical devices, and IVDs.
His FDA legal and regulatory work also has included tenures in private practice with McKenna &
Cuneo and Heller Ehrman, and as vice president, general counsel and secretary of Par
Pharmaceutical, a top public generic and specialty drug firm, where he helped spearhead the
company’s emergence from the Generic Drug Scandal. He also was, from 1994 to 1998, CEO of
FDANews.com, a premier publisher of regulatory newsletters and other specialty information
products for FDA-regulated firms.
He has taught and written on many topics relating to FDA regulation and associated commercial
activities and is a past member of the Food & Drug Law Journal Editorial Board. He earned his
A.B., magna cum laude, with high honors in history, at Bowdoin College, and his law degree at
Emory University.