1. Ethical Issues for Medical Writers DARSHAN KULKARNI PHARM.D., MS, ESQ. KULKARNI LAW FIRM Kulkarni Law Firm 1

2. Disclaimer  Not legal advice  May not be specific to your situation  Does not create an attorney/ client relationship Kulkarni Law Firm, PC 2

3. Fair Market Value (FMV) Kulkarni Law Firm 3

4. Outline FMV: FCA Anti- Kickback FCPA Sunshine Act Kulkarni Law Firm, PC

5. Fair Market Value: IRS  The price at which the property would change hands between a willing buyer and a willing seller when the former is not under any compulsion to buy and the latter is not under any compulsion to sell, both parties having reasonable knowledge of relevant facts.  Court decisions frequently state in addition that the hypothetical buyer and seller are assumed to be able, as well as willing, to trade and to be well informed about the property and concerning the market for such property IRS Revenue Ruling 59-60

6. Fair Market Value: HHS  “General market value” means the price that an asset would bring as the result of bona fide bargaining between well-informed buyers and sellers who are not otherwise in a position to generate business for the other party,” or  “the compensation that would be included in a service agreement as the result of bona fide bargaining between well-informed parties to the agreement who are not otherwise in a position to generate business for the other party, on the date of acquisition of the asset or at the time of the service agreement.”  “the price at which bona fide sales have been consummated for assets of like type, quality, and quantity in a particular market at the time of acquisition, or the compensation that has been included in bona fide service agreements with comparable terms at the time of the agreement, where the price or compensation has not been determined in any manner that takes into account the volume or value of anticipated or actual referrals.” 42 CFR 411.351

7. False Claims Act

8. What Matters - FCA  What is it?  Actions brought by the Department of Justice  Whistleblower or qui tam provisions allow individuals to bring actions in the name of the government, and can share in any recovery Kulkarni Law Firm, PC 8 No specific intent to defraud must be proved

9. What Matters -FCA  “ any person who— (A) knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval;  (B) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim; … “ Kulkarni Law Firm, PC 9 31 USC § 3729 “presents, or causes to be presented a false.. claim” “makes, uses, or causes to be made or used, a false record…”

10. Penalty & Damages - FCA … is liable to the United States Government for a civil penalty of not less than $5,500 and not more than $11,000, …, plus 3 times the amount of damages which the Government sustains because of the act of that person.” Kulkarni Law Firm, PC 10

11. Anti-kickback law

12. What Matters – Anti- Kickback Law  How is it different from the FCA? Kulkarni Law Firm, PC 12

13. Anti Kickback Law  Whoever knowingly and willfully solicits or receives any remuneration (including any kickback, bribe, or rebate ) directly or indirectly, overtly or covertly, in cash or in kind— (A) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program, or  (B) in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care Kulkarni Law Firm, PC 13 42 USC § 1320A–7B …solicits or receives any remuneration.. …for furnishing or arranging.. Any item or service for which payment was made..

14. Intent - AKL “a person need not have actual knowledge of this section or specific intent to commit a violation of this section.” Kulkarni Law Firm, PC 14

15. Anti-Kickback Law - Penalties “… shall be guilty of a felony and upon conviction thereof, shall be fined not more than $25,000 or imprisoned for not more than five years, or both.” Kulkarni Law Firm, PC 15 $25000 Imprisonment = 5 years Penalties

16. What Matters – Anti- Kickback Law Kulkarni Law Firm, PC 16 Seeding Trials Payments above FMV Investigator Initiated Trials

17. What Matters – Anti- Kickback Law Kulkarni Law Firm, PC 17 FCA Anti- Kickback

18. Anti-Kickback Law  Criminal statute that prohibits the exchange (or offer to exchange), of anything of value, in an effort to induce (or reward) the referral of federal health care program business http://www.healthlawyers.org/hlresources/Health%20Law%20Wiki/Anti-Kickback%20Statute.aspx

19. Foreign Corrupt Practices Act  “anti-bribery provisions of the FCPA prohibit the willful use of the mails or any means of instrumentality of interstate commerce corruptly in furtherance of any offer, payment, promise to pay, or authorization of the payment of money or anything of value to any person, while knowing that all or a portion of such money or thing of value will be offered, given or promised, directly or indirectly, to a foreign official to influence the foreign official in his or her official capacity, induce the foreign official to do or omit to do an act in violation of his or her lawful duty, or to secure any improper advantage in order to assist in obtaining or retaining business for or with, or directing business to, any person. http://www.justice.gov/criminal/fraud/fcpa/

20. Penalties

21. PARK DOCTRINE Kulkarni Law Firm, PC 21

22. Park Doctrine - Factors  Individual’s position in the company  Relationship to the violation  Did the official have authority to correct or prevent violation?  Knowledge of/actual participation in violation? Kulkarni Law Firm, PC Please let me know if you want full list.

23. Park Doctrine - Impact Kulkarni Law Firm, PC

24. Park Doctrine - What is it?  Also called “Responsible Corporate Officer (RCO) Doctrine”  RCO can be held liable for a first time misdemeanor (and subsequent felony) under the FD&C Act without proof of intent or negligence, even if no actual knowledge of or participation in specific offense Kulkarni Law Firm, PC

25. Penalties FINES AND PENALTIES Kulkarni Law Firm, PC 25

26. Administrative Penalties Kulkarni Law Firm, PC 26

27. Compliance planning

28. Compliance Kulkarni Law Firm, PC 28 Compliance Officer/ Committee Written Standards Training Program Report Overpayments Provide OIG with annual compliance reports Restrict employment of ineligible persons Please contact me for a printable list of factors

29. Authorship

30. Who is an Author?  Generally considered to be someone who has made substantive intellectual contributions to a published study” http://www.icmje.org/ethical_1author.html Kulkarni Law Firm 30

31. Author Responsibilities  An author must take responsibility for at least one component of the work, should be able to identify who is responsible for each other component, and should ideally be confident in their co- authors’ ability and integrity.  Some journals now request and publish information about the contributions of each person named as having participated in a submitted study, at least for original research. Kulkarni Law Firm 31

32. Authorship Crediting  substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data;  drafting the article or revising it critically for important intellectual content; and  final approval of the version to be published.  Authors should meet conditions 1, 2, and 3. http://www.icmje.org/ethical_1author.html Kulkarni Law Firm 32

33. Multi center studies  Acquisition of funding, collection of data, or general supervision of the research group alone does not constitute authorship.  All persons designated as authors should qualify for authorship, and all those who qualify should be listed.  Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content. Kulkarni Law Firm 33

34. Ghost Authorship  Ghost authorship, the failure to name, as an author, an individual who has made substantial contributions to an article, may result in lack of accountability. Ghost Authorship in Industry-Initiated Randomised Trials, http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0040019 (Last Accessed Janary 28, 2014) http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0040019 Kulkarni Law Firm 34

35. Ghost Writing What is it?: Honorary Authorship v. Ghost Authorship v. Academic Authorship

36. Scenario  You work for an medical writing company and are asked by ABC Life Sciences to help create a draft writeup for 4 physicians who have conducted a clinical trial, but don’t have the time to actually write out the article. They get you the data, but have interpreted it for you. They hope to get it published in NEJM. Who should be the author(s)? Can the Dept. Head by the Author? You submit the article to the physicians who then delete your name, but keep your edits and then submit it to NEJM. Do you retain any rights? The article is not picked up by NEJM, but S.E.A a new journal based in New Zealand is willing to publish it. They don’t follow ICJME criteria. Authorship? Is the assistance provided reportable under the Sunshine Act?

37. Scenario 2 You are asked to write a report on a 14 person single site, retrospective study to test efficacy of the drug. They hope you can emphasize the advantages on ease of use of the drug which compares the table to the intravenous version of the drug.

38. Scenario 3: You are asked to write a report on a 400 person double blinded, placebo controlled study to test efficacy of the drug. They hope that write the study which compares the drug to the appropriate control. What if the sponsor wants final review rights? What if the sponsor wants to insert promotional language? What if the sponsor wants to "bury" a paper? What if the sponsor wants to choose which journals?

39. Questions? Darshan Kulkarni Kulkarni Law Firm, PC Ph: 215-703-7842 S LIDES MADE AVAILABLE. @FDALawyers www.kulkarnilawfirm.com Kulkarni Law Firm, PC