FDA Sunshine Act

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CONFIDENTIAL
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3/25/2015
The Sunshine Act
What do we need to do?
When to we need to do it?

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3/25/2015
Background
 In a 2009 survey, 84% of physicians reported some form of
financial interaction with manufacturers of drugs, devices,
biologicals and medical supplies and 20% reported
reimbursement for attending meetings or CME
 These relationships can create positive outcomes,
particularly in the areas of research and development
 These relationships can create conflicts of interest and
blur the line between promotional activities and the
conduct of training, education and clinical practice

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3/25/2015
What is the Sunshine Act?
 Designed to provide greater transparency into the
relationships between the healthcare industry and
Healthcare professionals
 Does not bar gifts, but mandates reporting bu medical
product manufacturers to the Centers for Medicare and
Medicaid Services (CMS) any payments or other
transfers of value made to physicians or teaching
hospitals
 Enacted by Congress in March, 2010 as section 6002 of
the Patient Protection and Affordable Care Act – known
as Healthcare Reform – and was effective as of
April 9, 2013

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3/25/2015
Other Financial Interests Reporting
 Nine States have laws which limit or ban gifts, regulate
behavior, or require registration/reporting
 NIH requires all grantees to disclose significant financial
relationships with manufacturers
 FDA requires drug sponsors to report financial ties with
investigators

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3/25/2015
Categories of To Be Reported
 Consulting Fees
 Honoraria
 Grants
 Gifts
 Entertainment
 Travel
 Education
 Research
 Charitable contributions
 Royalty or license
 Current or prospective ownership or investment interest
 Direct compensation for searching as faculty for CME programs

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3/25/2015
Manufacturer Obligations
 A company is an “applicable manufacturer” under Title
42, Section 403.902 if it has one or more FDA-approved
or FDA-cleared products
 If a company is in the R&D phase and if not “engaged in
the production, preparation, propagation,
compounding, or conversion of a covered drug, device,
biological or medical supply” then the law does
not apply

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3/25/2015
What do manufacturers need to do?
 Create a system to track all payments initiated to
physicians and teaching hospitals, from all departments
 Create unique physician or teaching hospital/medical
entity identifiers
 Coordinate requirements of CMS, FDA and States to
avoid duplication of effort and information