FDA: Conflict of Interest Policy regarding Dietary Supplements

anthony roberts filed this request with the Food and Drug Administration of the United States of America.
Tracking # 2017-5085
Status
Completed

Communications

From: anthony roberts

To Whom It May Concern:

This is a request under the Freedom of Information Act. I hereby request the following records:

I am seeking all written policies regarding members of the FDA who deal with dietary supplements and their obligations to avoid personal conflicts of interest in that industry. I would like to documents that explain whether or not members of the FDA are allowed to earn money from dietary supplements directly (by selling them, owning a company that sells dietary supplements, or even by holding stock in companies that do) or indirectly (i.e. by giving talks at industry events or consulting). I would like to know if there is a vetting process before hiring to avoid these types of conflicts, and would like a copy of the hiring documents that explain same. Finally, I would like documentation on whatever conflicts are allowed, and a list of those conflicts (names, companies, types, etc...) that the FDA has known to exist from January 1st, 2009 through June 7th, 2017.

I would like fees to be waived as I am a professional member of the media, the requested documents will be made available to the general public, and this request is not being made for commercial purposes.

In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.

Sincerely,

anthony roberts

From: Food and Drug Administration

An interim response, stating the request is being processed.

From: Kotler, Sarah

Dear Requester,

FDA has received your request regarding FDA employees and conflicts of interest. All Ethics regulations and policies for FDA employees are available at:

https://www.fda.gov/AboutFDA/WorkingatFDA/Ethics/default.htm

Please contact me directly if you have any questions at 301-796-8976 or Sarah.Kotler@fda.hhs.gov. You may also contact the FDA FOIA Public Liaison, Office of the Executive Secretariat, 5630 Fishers Lane, Room 1050, Rockville, MD 20857; email: FDAFOIA@fda.hhs.gov<mailto:FDAFOIA@fda.hhs.gov>.

Sincerely,

Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>

[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

From: Kotler, Sarah

We responded to this request.

Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>

[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

From: anthony roberts

This request asked three individual pieces of information:

1. All written policies regarding members of the FDA who deal with dietary supplements and their obligations to avoid personal conflicts of interest in that industry (documents that explain whether or not members of the FDA are allowed to earn money from dietary supplements directly (by selling them, owning a company that sells dietary supplements, or even by holding stock in companies that do) or indirectly (i.e. by giving talks at industry events or consulting)

2. Documentation that explains whether or not there is a vetting process before hiring to avoid these types of conflicts, and related hiring documents

3. Documentation on whatever conflicts are allowed, and a list of those conflicts (names, companies, types, etc...) that the FDA has known to exist from January 1st, 2009 through June 7th, 2017

The response we received would have covered #1, but certainly not #2 or #3.

In other words, the policy is now clear (thanks to the partial response we received), but we are unable to determine how it is enforced or even if it has ever been enforced, or if exceptions have been allowed in any instances, and if so, why and to whom were they allowed.

From: Kotler, Sarah

Hi, with respect to #2, FDA would follow whatever hiring procedures are required by the Office of Personnel Management and the Office of Government Ethics. With respect to #3, we would need to know the names of specific employees to see whether a conflict was found and allowed.

Thanks,

Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>

[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

From: anthony roberts

Thank you. I will file those additional FOIAs and we can close this one out.

Files

pages

Close