Transcript The Impact of HIPAA on Clinical Research

"What You Need to Know
Before
Beginning Your Clinical Trial"
FDA Breakfast Briefing
October 23, 2002
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Financial Disclosure – Duties
and Strategies for Clinical
Studies
Michael A. Swit, Esq.
Law Offices of Michael A. Swit
539 Samuel Ct.
Encinitas, CA 92024
760-815-4762; fax: 760-454-2979
[email protected]
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Financial Disclosure – the
Basics


Goal -- Reduce potential for bias in clinical
studies and enhance human subject
protection
How implemented


FDA Rules @ 21 CFR Part 54; Feb. 2, 1998 –
published in F.R.; effective 1 year later
FDA Guidance: “Financial Disclosure by Clinical
Investigators” – March 20, 2001
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Basics…

Requirements – for any application
(NDA, PMA, BLA, etc.) submitted after
effective date, applicant must:


disclose data on the “financial interest” of
“clinical investigators” of “covered clinicals
studies; or
certify there are NO disclosable interests
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Basics…

“Clinical investigators” – covers:




Principal investigators
Sub-investigators named in 1572
spouses and dependent children
exempted: per March 2001 Guidance -- “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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Basics…

The Five Basic “Financial Interests”
subject to disclosure -
Direct payments > $25,000 -- aka “Significant
Payments of Other Sorts” or SPOOS


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excludes costs to conduct the 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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Basics …

The Five “Financial Interests” …


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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Basics …

The Five “Financial Interests” …

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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Basics …

“Covered Studies” –


trials 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


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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
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
How FDA Addresses
Questionable Financial Deals

FDA may take "any action it deems
necessary to ensure the reliability of the
data, including":

FDA itself auditing the data from that
investigator;

Requesting the applicant submit further
analyses of data; e.g., to evaluate the effect of
that investigator's data on the overall study data;

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and …
How FDA Addresses Questionable
Financial Deals …

FDA may take "any action it deems
necessary” …

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Requesting sponsor conduct additional independent
studies to confirm the results of the questioned study;
and
Refusing to treat the covered clinical study as
providing data that can be the basis for agency
action (e.g., an application approval).
Addressing Financial
Disclosure Before FDA Does

Clinical investigator selection process -make compliance an integral aspect of
selection

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find out early, before clinical protocols are set in
stone; allows you to possibly address via study
design to minimize bias
if present, document per regulations
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Addressing Financial
Disclosure Before FDA Does …

Clinical study agreements should
“mirror” the regulations –


mandate disclosure of Interests or a
certification there’s nothing to disclose
a constant duty to update if there is any
change
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Addressing Financial
Disclosure Before FDA Does …

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include the right to obtain a one-year post
study update regarding interests
CRO agreements should obligate the
CRO to obtain disclosure/ certification
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Minimizing Bias In Event of
Financial Disclosure

Key – take the action early; you
will have to describe it later in your
marketing application and you also
may not be able to address
effectively later
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Minimizing Bias In Event of
Financial Disclosure …

Possible angles:
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multiple study sites/investigators
blinding
objective endpoints
randomized assignment of patients to
treatment v. control groups
have someone other than investigator
measure subjective endpoints
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Other Considerations

The Jesse Gelsinger scenario -- If an
investigator has a significant financial
interest, has that been adequately disclosed
in the study’s informed consent
documents??

Other entities may also impact financial
disclosure duties, such as:


the investigator’s institution (e.g., university or
hospital) may have separate rules;
HHS rules may apply as well (e.g., if federally
funded).
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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 229
Encinitas, 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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