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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 [email protected] 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 FDACounsel.com 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 … FDACounsel.com 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 FDACounsel.com 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 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 FDACounsel.com PREEMPTION – Supreme Court Cases … Buckman – 2001 – Supreme Ct. rules FDA’s more detailed premarket approval process did preempt certain state tort claims 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 FDACounsel.com 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. FDACounsel.com 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 FDACounsel.com 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 FDACounsel.com 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 FDACounsel.com 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. FDACounsel.com 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 FDACounsel.com 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 FDACounsel.com 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 FDACounsel.com 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 FDACounsel.com 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 FDACounsel.com 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) FDACounsel.com 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 FDACounsel.com 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 FDACounsel.com 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 FDACounsel.com 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 FDACounsel.com 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. FDACounsel.com 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 FDACounsel.com 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 FDACounsel.com 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 FDACounsel.com 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) FDACounsel.com 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 FDACounsel.com 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 [email protected] Also Admitted In Virginia and D.C.. FDACounsel.com 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. FDACounsel.com The End