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Michael A. Swit, Esq. Vice President, Life Sciences

State Regulation of Clinical Trials 5th National Conference on Managing Legal Risks in Structuring and Conducting Clinical Trials American Conference Institute Boston September 27, 2006. Michael A. Swit, Esq. Vice President, Life Sciences. MOST ACTIVE CLINICAL RESEARCH STATES.

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Michael A. Swit, Esq. Vice President, Life Sciences

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  1. State Regulation of Clinical Trials5th National Conference on Managing Legal Risks in Structuring and Conducting Clinical Trials American Conference Institute Boston September 27, 2006 Michael A.Swit, Esq.Vice President, Life Sciences

  2. MOST ACTIVE CLINICAL RESEARCH STATES 2

  3. HOW CAN WE KNOW ALL THE STATES’ LAWS? • You can’t (easily) • One general source: State-by-State Clinical Trial Requirements Reference Guide, Sept. 2004, Serio, et al., Editors, Barnett Educational Services • 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 3

  4. California v. Texas -- Age of Consent 4

  5. Consent Process … 5

  6. Consent Process ... 6

  7. Consent Process … specifics needed 7

  8. Consent Process … 8

  9. Consent Process … specifics needed 9

  10. LEGALLY AUTHORIZED REPRESENTATIVE 10

  11. LEGALLY AUTHORIZED REPRESENTATIVE 11

  12. IRBS 12

  13. RECORDS REQUIREMENTS 13

  14. RECORDS REQUIREMENTS 14

  15. RECORDS REQUIREMENTS 15

  16. STATE IND RULES 16

  17. EMERGENCY EXPERIMENTATION 17

  18. MENTALLY ILL OR DEVELOPMENTALLY DISABLED STUDIES 18

  19. MENTALLY ILL OR DEVELOP-MENTALLY DISABLED … 19

  20. Research on Prisoners 20

  21. PRACTICAL ADVICE • 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) 21

  22. PRACTICAL ADVICE … • 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 22

  23. The End

  24. About the speaker … Michael A. Swit, Esq., who is Vice President, Life Sciences at THE WEINBERG GROUP INC., has extensive experience in all aspects of FDA regulation with a particular emphasis on drugs and medical device regulation. In addition to his private legal and consulting 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 joining THE WEINBERG GROUP, he served in the FDA Regulatory Law Practices at both Heller Ehrman and McKenna & Cuneo, first in that firm’s D.C. office and then 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. 24

  25. 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 michael.swit@weinberggroup.com www.weinberggroup.com 25

  26. 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 26

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