COLLEGE OF MEDICINE
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With Pharmaceutical Manufacturers |
These guidelines establish a framework for screening existing and potential financial relationships between the University of Florida College of Medicine and pharmaceutical manufacturers. The goal of these guidelines is to ensure that faculty members and staff structure financial arrangements with pharmaceutical manufacturers that comply fully with relevant federal and state fraud and abuse laws.
These guidelines apply to all current and future financial relationships and are intended to educate faculty so they can identify financial arrangements that are permissible, financial arrangements that are prohibited and financial arrangements for which faculty should seek additional guidance before proceeding.
Guideline #1 All financial arrangements with pharmaceutical manufacturers must be structured to ensure that no payment is made or received by the College of Medicine that is designed or intended to induce any referral for “goods or services” (e.g., pharmaceuticals).
Guideline #2 In order to determine whether faculty should seek additional guidance from the College of Medicine Office of Research Affairs before proceeding with a financial arrangement for a drug study, the faculty member should answer the following questions:
(a) Is the patient, Shands or any third party payor (other than the drug manufacturer) responsible for payment of the cost of the drug(s) used in the study?If the answer to both of these questions is “yes,” the financial arrangement may be in violation of fraud and abuse laws. The faculty member should submit appropriate documentation and seek review of the financial arrangement by the College of Medicine Office of Research Affairs._____ YES _____ NO
(b) Does the study evaluate the use of an FDA-approved drug for its effects on any of the drug’s FDA-approved indications?
_____ YES _____ NO
Guideline #3 The faculty member is responsible for assisting in the determination of whether payments to be made by the pharmaceutical manufacturer are consistent with the fair market value for the services to be provided by the College of Medicine as well as consistent with other University requirements, including federally-mandated cost accounting requirements and overhead charges. Documentation of any such calculations should be maintained by the College of Medicine Office of Research Affairs.
Guideline #4 All financial arrangements must be in writing and approved by the appropriate University signatories. Individual faculty members have no authority to enter into any such agreements and may not enter into any oral agreements that might result in remuneration being paid to the College of Medicine or the faculty member.
Guideline
#5 The College of Medicine Office of Research
Affairs is available to assist and educate faculty who are involved in
negotiating financial arrangements with pharmaceutical manufacturers (or
other similar health care related organizations).
* * *
These guidelines are not intended to address every
issue or answer every question that may arise with respect to the screening
of financial relationships with pharmaceutical manufacturers. If
you have any questions or concerns regarding these guidelines, please contact
the College of Medicine Office of Research Affairs at 352-392-5398.
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