About FDA

Listing of Significantly Regulated Organizations (SROs)

Prohibited Financial Interests Applicable to FDA Employees

Employees of the Food and Drug Administration (FDA) participate in regulatory and product approval matters that substantially affect significant sectors of the U.S. economy, including the food, pharmaceutical, medical device, veterinary medicine, biotechnology, cosmetic and tobacco industries.  Because of the FDA’s role as a unique consumer protection agency, FDA employees must comply with a broad restriction that prohibits FDA employees as well as their spouse and minor children from holding financial interests, like stock, in certain businesses regulated by FDA.  This includes many companies working in the drug, biologic, medical device, food, and tobacco industries, among others.  These businesses are called Significantly Regulated Organizations (SROs).  

In large part, this restriction exists to help FDA employees avoid conflicts of interest under the criminal conflict of interest statute, 18 U.S.C. § 208.  This law generally prohibits Federal employees from participating in any official matters that can have a direct and predictable effect on their financial interests or those imputed to them, including those of their spouse or minor children. 

The restriction on holding financial interests in SROs is broad, applicable to interests in publicly traded, privately held companies, as well as certain sector funds that have a stated  practice of concentrating its investments in SROs.

Please note that certain limited exceptions to the general prohibition on holding SROs do exist. Further guidance regarding such exceptions is available here.

To help employees determine whether or not an entity is considered to be an SRO, FDA maintains a searchable list of publicly-traded companies (traded on U.S. as well as foreign stock exchanges) that it has determined to meet the definition of an SRO. The list is updated on a monthly basis. To access the SRO List, click here.

The SRO list is a comprehensive and important resource to check regularly, however, it is not definitive. There are some situations where a financial interest may constitute a prohibited financial interest in an SRO, even if it is not included on the SRO List. For example, the SRO List does not include:

  • Companies that are privately-held;
  • Investments in private equity or hedge funds;
  • Many new companies, for example those that may not have a record of sales of FDA regulated products, but which operate predominately in fields regulated by FDA
Aside from searching the SRO List, you may contact an ethics specialist in FDA’s Division of Ethics and Integrity (DEI), who can help you determine whether or not a particular company or business, publicly-traded or privately-held, constitutes an SRO. You can reach DEI by sending an e-mail to FDAEthics_Advice@fda.hhs.gov or call the FDA Ethics Advice Hotline at (240) 402-1111. Please provide the business name and/or DUNS Number if possible.
 
Additionally, FDA maintains a separate listing of investment funds that are prohibited for FDA employees because the funds have a stated policy or practice of investing in SROs. To access the list of prohibited investment funds, click here.

Page Last Updated: 07/03/2017
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