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U.S. Department of Health and Human Services

About FDA

CTP Ombudsman

 

Who is CTP’s Ombudsman?

Lawrence “Jake” Romanell is CTP’s Ombudsman. Prior to joining CTP, Mr. Romanell served as the Center for Devices and Radiological Health (CDRH) Deputy Ombudsman since 2010. Jake began his FDA career at CDRH as a microbiologist and performed scientific reviews for the division of Ophthalmic and Ear, Nose and Throat Devices. He has held a variety of other positions within CDRH. Before joining FDA, Jake served for 14 years as the assistant supervisor of the clinical microbiology laboratory at D.C. General Hospital in Washington D.C.

Mr. Romanell succeeded Les Weinstein, CTP’s first appointed Ombudsman who retired in October 2013. Ella Yeargin served as the Acting Ombudsman during the period following Mr. Weinstein’s retirement, and is currently CTP’s Associate Ombudsman. Prior to joining the CTP Ombudsman’s Office in January 2013, Mrs. Yeargin worked in CTP’s Freedom of Information (FOIA) Office. She began her FDA career as a Presidential Management Fellow.

How to Contact the Ombudsman’s Office

Telephone: 301-796-3095
E-mail address: CTPOmbudsman@fda.hhs.gov

 

What does the CTP Ombudsman do?

CTP established its Ombudsman’s Office in 2010. The Ombudsman’s Office responds to a range of inquiries, including complaints from various stakeholders and the public, and facilitates the resolution of disputes between CTP and the tobacco industry. The office is an advocate for fairness and strives to maintain impartiality and neutrality while providing this service.
Among other responsibilities, the CTP Ombudsman’s Office:

  • responds to inquiries and/or complaints from the tobacco industry, law firms or consultants representing industry, advocacy groups, public and private research institutions, health care providers, and consumers;
  • facilitates the resolution of disputes between CTP and the tobacco industry;
  • provides general information on the regulatory process; and
  • helps to facilitate dialogue between stakeholders and CTP staff. 

The Ombudsman’s Office can provide an empathetic ear for issues and concerns even if they do not rise to the level of a complaint or dispute.

Based on the nature of the contacts received, the Ombudsman’s Office advises CTP leaders about ways to assure that CTP’s procedures, policies, and decisions are of the highest quality and are fair and equitable. The Ombudsman can also be called upon to help resolve  internal scientific disputes in regulatory decision-making between CTP managers and staff.

 

Relation to FDA Office of the Ombudsman

The function of the CTP Ombudsman parallels that of the FDA Office of the Ombudsman, located in the Office of the FDA Commissioner, but provides an avenue for resolving issues involving CTP programs at a level closer to the source. Because the FDA Office of the Ombudsman has agency-wide jurisdiction, it is appropriate to contact that office when an issue involves more than one FDA Center, when an effort to resolve a dispute or an appeal of a decision was not successful at the Center level, or at any time when involvement by someone outside CTP might be useful.

 

When to Contact the CTP Ombudsman

Complaints and Disputes: The Ombudsman’s Office does its best to respond in a timely and effective manner. Although anyone may contact the office at any time, people should, if possible, first try to resolve any complaint or dispute within the responsible CTP Office. The Ombudsman does not get involved in matters that are in active litigation. 

 

General Comments and Suggestions

The Ombudsman is interested in hearing about the effectiveness of CTP’s programs and about problems that may be getting in the way of implementation of  the Center’s regulatory responsibilities. We welcome such input because it helps CTP to continually assess and improve upon its work. 

 

Confidentiality

Parties who contact the Ombudsman’s Office may prefer to keep their identity, name, company name, or even the nature of their complaint confidential. Generally, we can keep this information confidential if requested. Naturally, a pledge of confidentiality may preclude the Ombudsman from facilitating a resolution to a specific problem. If so, we will explain this conflict and will not proceed to look into a matter without permission to share the previously confidential information. There are a few areas, however, in which confidentiality cannot be preserved, such as allegations of criminal activity, which must be reported to the FDA Office of Criminal Investigations. Even in these situations, though, the identity of a confidential source may be protected from disclosure to the public. FDA has a very strict non-retaliation policy that protects anyone who complains about the Agency or any of its employees. The CTP Ombudsman follows a code of ethics and operating principles drawn from those established by the Coalition of Federal Ombudsmen, the United States Ombudsman Association, and the International Ombudsman Association. These include standards for ensuring confidentiality, impartiality, and informality.