State Regulation of Clinical Trials
Society for Quality Assurance
Annual Meeting
Washington, D.C.
October 16, 2003
Michael A. Swit, Esq.
FDACounsel.com
Law Offices of Michael A. Swit
mswit@fdacounsel.com
FEDERALISM – Or Why State
Laws Matter

U.S. Constitutional legal system
– The powers not delegated to the
United States by the Constitution, nor
prohibited by it to the States, are
reserved to the States respectively,
or to the people. (10th

Amendment)
States – broad powers – to
“police” conduct, particularly on
health issues
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Why State Laws Matter …


But, if FDA, HHS, etc., already
regulate clinical studies, why can’t
we just follow the federal rules?
“Preemption” – where federal and
state law coexist, it is possible that
federal law will “preempt” – or
trump – state law.
But, not always …
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FEDERAL PREEMPTION –
When Does Uncle Sam Win?



Not all time!!
In some cases, preemption may be
explicit under the federal statute – see
medical device laws
In other cases, if not explicit, the
federal scheme



must completely occupy the “field” to preempt;
or
If irreconcilable conflict between federal and
state; or
Using state standard would frustrate the goals of
the federal law
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PREEMPTION – Supreme
Court Cases


No case in the clinical research arena; however,
guidance exists in other cases, including FDA-related
Silkwood v. Kerr-McGee – 1984

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company claimed punitive damages awarded preempted by
federal laws on nuclear handling
Supreme Court – explicit preemption under Atomic Energy
Act did not extend to state punitive damages awards in a
claim relating to nuclear safety
Medtronic v. Lohr – 1996 -- Supreme Ct. ruled
state tort law claims not preempted by FDA 510(k)
device clearance process
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PREEMPTION – Supreme
Court Cases …

Buckman – 2001 – Supreme Ct. rules FDA’s more detailed premarket approval
process did preempt certain state tort claims



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Courts did not fully decide the question of whether general state tort duties were
preempted by the MDA; some language suggests they would.
NOTE: the medical device cases rely on a specific provision of device statutes – 21
USC §360k(a) – that precludes a state from establishing (or continuing) a requirement
that differs or adds to those in the Medical Device Amendments (“MDA”) of 1976.
No such explicit statutory provision vis-a-vis federal clinical research law.
Thus, assume that the courts would not regard the federal scheme as so
pervasively regulating as to preempt.
Courts -- might not set aside on preemption basis state laws on
clinical research – if they set forth more detailed requirements – reluctance to
relax standards of care relative to patient safety
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WHICH STATES ARE MOST ACTIVE IN
CLINICAL RESEARCH?
Population Rank1
# Clinical Studies Rank2
1
California
Maryland (19)
2
Texas
New York
3
New York
California
4
Florida
Texas
5
Illinois
Pennsylvania
6
Pennsylvania
Ohio
7
Ohio
Washington (15)
8
Michigan (13)
Illinois
9
New Jersey (20)
Florida
10
Georgia (19)
Massachusetts (13)
11
North Carolina
North Carolina
12
Virginia (18)
Missouri (17)
1.
2.
http://www.census.gov/population/cen2000/tab04.txt
Compiled from http://www.clinicaltrials.gov Note: # in parens is rank in
other column.
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HOW CAN WE KNOW ALL THE
STATES’ LAWS?

You can’t (easily)

One general source: ClinLaw
SM
http://www.clinlaw.com –
overview of state requirements with citations (but, lacks full text)


Focus on key states -- e.g., see our chart
Work with your IRBs – they are required
to know local conditions under federal law –
thus, protocols and consents should be
tailored by them to meet local rules
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California v. Texas -- Age of
Consent
California
Texas
Majority – 18
Mental Health Care – 12
Medical Care – 15 or living
Majority – 18, unless
apart from parents
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disabilities of minority
removed
Mental Health Care &
Medical Care – 18, unless 16
and independent, then can
consent to:
♦ infectious disease
treatment
♦ pregnancy treatment (but
not an abortion)
♦ substance abuse
Consent Process …
California
Written consent required prior to
administering an experimental drug
(H&S 111525)
Texas
No similar explicit rule on
experimental drugs.
But, separate law that hospital
patients have right to be informed of
experimental or research projects
affecting their treatment
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Consent Process
California
Informed consent must include all
pertinent info, including financial
(Moore v. Regents)
Experimental Subjects “Bill of
Rights” – must be provided to
subject and signed before consent to
research
H&S § 24172.
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Texas
No similar explicit rule on financial
disclosure; but, after Gelsinger, little
question is an implied obligation to
consent process.
Not specifically addressed.
Consent Process …
specifics needed
California
Must:
♦ Sign
♦ Date
♦ Witness
♦ State purpose
♦ State any placebo use
♦ Risks & benefits
♦ Alternatives
♦Recovery time
♦ Withdrawal rights
♦ Name & institution doing study
♦ Sponsor or funding source
♦ Name & address of impartial third-party
contact to complain to
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Texas
Detailed requirements not specifically
addressed in detail.
Consent Process …
California
♦ Minors – need parental consent; &
assent of children seven+ years old
Texas
Minors – if parent, not available,
others can (e.g., grandparents)
per Tex. Family Code § 32.001
Old law – minor assent to mental
health treatment required;
repealed in 2001
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Consent Process …
specifics needed
California
Texas
Consent relative to Research on Mentally Ill:
♦ If at state hospitals, more requirements apply:
• confidentiality statement
• contact info. For questions, costs & future
findings
♦ To review confidential records of
developmentally disabled person, researcher
must obtain informed consent of subject or LAR
♦ Short form consent is possible (17 CCR 50429)
♦ IRB can authorize waiver of consent in certain
limited circumstances (17 CCR 50427)
Consent relative to Research on Mentally Ill (25
TAC 414.758) – must meet 45 CFR § 46
requirements, plus:
♦ must include any extension of length of stay at
facility
♦ ability to get research drug or device after
research over
♦ use of placebo
♦ if research involves using test article known to
be ineffective for targeted pop.
♦ risk of deterioration
♦ greater requirements if research involves more
than minimal risk:
• independent professional must assess capacity
of individual to consent
♦ consent “must be assessed and enhanced
throughout” the research
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LEGALLY AUTHORIZED
REPRESENTATIVE
California
Texas
Priority Order:
(H&S 24178)
♦ Agent via a health care directive
♦ conservator or guardian
♦ spouse
♦ adult child
♦ custodial parent
♦ adult sibling
♦ adult grandchild
♦ closest available adult kin
Priority order:
(H&S § 313.004)
♦ Spouse
♦ Adult child of patient w/waiver &
consent of all other adult childre
♦ Majority of reasonably available adult
children
♦ Parents
♦ Person last ID’d by patient prior to
incapacity
♦ Nearest living relative
♦ Member of clergy
Note: if two or more of same priority, if
any objects, NO CONSENT
Note: different order for emergency room
use
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Note: majority rules if more than one
LEGALLY AUTHORIZED
REPRESENTATIVE
California
Texas
If LAR involved, informed consent for
research can only be for research related to
the health of the subject (H&S § 24175)
Not addressed specifically
If subject has previously appointed a health
care power of attorney, can appoint a
“surrogate” by personally informing the
supervising health care provider. If so,
surrogate controls over POA. (H&S § 24175).
Not addressed specifically
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IRBS
California
Texas
State Dept. of Health Services must
“accept” the IRB; however, if you’re under a
federal assurance, you’re deemed accepted
(H&S § 111540)
Not specifically addressed; but see
below
Studies on Developmentally Disabled:
IRB must meet 17 CCR 50401:
♦ 5 members
• 1 lay member
• 1 member focused on rights of subjects
• 1 member not affiliated w/facility
♦ Must review protocols within 31 days of
receipt
Studies on Developmentally Disabled:
IRB must meet 25 TAC 414.755(d):
♦ 3 members must know the mental
disorders:
• one professional
• 2 must have been mentally ill or
retarded, or a family member of such, or
an advocate
♦ Facility IRB must be approved by
Texas Dept. of Mental Health’s Office of
Research Admin. (ORA)
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RECORDS REQUIREMENTS
California
♦ Illegal to disclose medical information
unless compelled by court, law
enforcement agency or patient.
♦ Disclosure is OK to a P.I. or research
organization for research purposes if
patient ID protected
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Texas
♦ Similar
♦ Similar, but also, Covered Entity must:
• document consent
• document waiver OK’d by an IRB or
privacy board, that says:
◘ use of PHI is minimal risk to person
◘ privacy rights will not be adversely
affected
◘ privacy risks are reasonable relative to
anticipated research benefits
◘ adequate plan to keep identifiers from
being improperly used
◘ plan to destroy identifiers later
◘ written assurances PHI will not be
reused or disclosed
RECORDS REQUIREMENTS
California
Texas
♦ Records release forms must be at
least 8 point type and include:
• specific uses
• name of provider
• name of info recipient
• expiry date
Similar rule – Occupations Code §
159.005(b); consent must specify:
• records to be released
• reasons for release
• recipient
♦ Disclosure of lab results via
electronic means is barred
Not specifically addressed
♦ Federal HIPAA overrides state law
(H&S § 130311, as of 9/02)
♦ HIPAA rules essentially apply (H&S §
181.101
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RECORDS REQUIREMENTS
California
Pharmaceutical companies (but not
medical device firms) barred:
♦ from disclosing medical information
about a patient without consent.
♦ conditioning receipt of drugs on patient
waiving those rights, except vis-à-vis
enrollment in a clinical study
Developmentally disabled research:
♦ to get access, researcher must sign
confidentiality pledge per 17 CCR 50421
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Texas
Not specifically addressed
Not specifically addressed in this
detail.
STATE I.N.D. RULES
California
Texas
None explicit.
None explicit.
BUT, cancer research – if not
under a federal IND, must
meet several requirements
under H&S § 109325,
including a written
statement filed with state
BUT, to use approved drug
for research, sponsor must
submit a copy of FDA
approval letter to Texas
Commissioner of Health
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EMERGENCY
EXPERIMENTATION
California
Texas
Need for consent for
experimental treatment is
exempted if a life-threatening
situation (assumes incapacity
to consent)
Not addressed specifically,
except a psychoactive drug
can be administered
without consent to a
resident who is having a
medication-related
emergency.
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STUDIES ON MENTALLY ILL OR
DEVELOPMENTALLY DISABLED
California
♦ Executive director of state
hospital also must OK research
♦ Other Detailed Requirements:
• researcher duties (17 CCR
50413)
• IRB
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Texas
SAME – 25 TAC 414.754(k)
Detailed requirements (25 TAC
414.751 et seq.)
♦ adopts Belmont Report
♦ must be a court order for mental
health services in effect before can
approach individual in protective custody
on being involved in research
(25 TAC 414.754(f)
MENTALLY ILL OR DEVELOPMENTALLY DISABLED …
California
Texas
No similar requirement relative to
involuntary commitment, but I.C.
rules in H&S § 24170 are similar.
If involuntarily committed:
♦ no placebos
♦ no ineffective doses or medications
♦ if prior studies with 100 or fewer
patients have found minimal or no proof
of safety & effectiveness
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Research on Prisoners
California
Inmates have right to choose; I.C.
must include all (from prior slide),
and:
♦ right to withdraw
♦ remuneration
NOTE: only applies to behavioral
research
Penal Code § 3502 – bars biomedical
research on prisoners
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Texas
Not addressed specifically.
PRACTICAL
CONSIDERATIONS



Retain clinical investigators with
sophistication in clinical research; much
of state law relates to practice of medicine
Start early – requirements are detailed
FDA (arguably) can cite you for missing
a state requirement – will cite a federal
violation (e.g., failure to monitor; inadequate
consent; IRB not observing local conditions)
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PRACTICAL
CONSIDERATIONS …


If using a CRO, consider those that have local
offices in states you have clinical
When in doubt, get local counsel!!
Disclaimer: I am not admitted in Texas
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Questions?
Michael A. Swit
Attorney at Law
Law Offices of Michael A. Swit
539 Samuel Ct. , Suite 229 ♦ Encinitas, CA 92024
Office: 760-815-4762 ♦ O-Fax: 760-454-2979
mswit@fdacounsel.com
Also Admitted In Virginia and D.C..
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About your presenter …
Michael A. Swit has over 19 years of experience addressing critical FDA legal and
regulatory issues. His vast and varied experience, which he is now providing as a solo
practitioner, includes serving 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 FDAregulated 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-regulated community. From May 2001 to to May
2002, Mr. Swit was special counsel in the FDA Law Practice Group in the San Diego
office of Heller Ehrman White & McAuliffe. Before that, he was 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 and editing a guide to the generic drug approval process, Getting Your
Generic Drug Approved. He is a member of the California, Virginia and District of
Columbia bars.
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The End