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Frequently Asked Questions (FAQs)

What is the Office of Inspector General (OIG) and what does it have to do with CDC and the Select Agent Program?

The Office of Inspector General (OIG) is a separate entity within HHS. The OIG primarily investigates fraud and abuse within the Medicare program. However, as of March 2003, the Select Agent regulations authorize the OIG to impose “Civil Money Penalties” against violators of the Select Agent Program. The OIG, and its legal branch (The Office of Counsel to the Inspector General), investigate and pursue violations of the Select Agent Program on behalf of CDC and HHS. The Office of Counsel to the Inspector General (OCIG) provides legal representation for all Select Agent violations within HHS, including: interpreting the Select Agent regulations, overseeing investigations, negotiating settlements, and filing administrative actions.

Do we need an attorney to respond to a potential Select Agent Program violation identified by the OCIG rather than letting our regulatory affairs personnel handle the problem?

Yes, for two reasons:

• It is unwise to allow non-lawyers to attempt to negotiate a settlement with the OCIG. The OCIG, as the legal counsel for the OIG, is a select group of lawyers within HHS that orchestrates million dollar settlements for health care fraud in addition to enforcing the Select Agent Program. During 2003-2004, the OCIG represented HHS in settlements with Tenent Healthcare, AstraZeneca, Pfizer, and other large companies. The OCIG has experienced lawyers who are skilled at negotiating large civil settlements. The OCIG is not a typical regulatory agency. It undertakes very critical legal analysis for each settlement. Often, layman fail to properly respond to the OCIG’s questions regarding violations, and neglect to provide the OCIG with key information that may enable it to assess smaller Civil Money Penalties.

• Communications such as e-mails and letters to an attorney about potential violations can be protected by the attorney client privilege. Communications between regulatory affairs personnel are not privileged and can be subpoenaed and reviewed by the government. For example, an e-mail sent to an attorney that states, “we never obtained a Security Risk Assessment for employee Jane Doe,” could be protected by the attorney client privilege. That same e-mail sent between regulatory affairs personnel is not privileged, and can be reviewed by the government.

Why should we retain Goldberg Legal Services to represent us for a violation instead of using our in-house counsel or the firm we traditionally use for litigation?

There are adept attorneys in every jurisdiction across the country. Goldberg Legal Services offers more than competent representation, it offers first hand, personal knowledge about the procedural and substantive mechanisms behind the Select Agent Program. Attorney Goldberg worked for the OCIG. He worked with the Chief Counsel to the Inspector General and his senior attorneys on the first ever Select Agent settlement for HHS. Mr. Goldberg oversaw the investigation of over 15 violations. He worked with CDC in analyzing potential violations. He drafted proposed language for the final rule on Select Agents that will be published in 42 CFR part 73. This knowledge is invaluable for defending a Select Agent violation.

Can Goldberg Legal Services review our operations to tell us if we are in compliance with the Select Agent regulations even if we are not being investigated?

Yes. Goldberg Legal Services will review any aspect of your compliance program such as training, security, or emergency response, and provide you with a legal opinion as to whether you have achieved compliance.

I am a Responsible Official for my company or institution, can I be held personally liable?

Yes. The regulations make it clear that any person or entity can violate the Select Agent Program. The regulations do not prohibit the OIG from pursuing Responsible Officials for violations committed within their company or institution.

What are the potential fines for violating the Select Agent Program regulations?

Companies and other entities can be fined up to $500,000 for each violation of the Select Agent Program regulations. An individual can be fined up to $250,000 for each violation. Under the regulations, there is no cap on penalties. A violator can receive the maximum penalty for each violation of the regulations. Thus, two separate violations committed at the same time could yield a $1,000,000 penalty.

Are there criminal penalties for violating the Select Agent Program?

Yes. The OIG enforces civil penalties for violations of the Select Agent Program. However, criminal penalties also exist. 18 U.S.C. § 175b establishes three criminal violations for the possession, use, and transfer of select agents. Any person found guilty of violating Section 175b can be imprisoned for up to five years.

Do bankrupt or dissolved companies present special concerns for Select Agent Program compliance?

Yes. The bankruptcy or dissolution of a company that possesses select agents is an area of grave concern for directors, officers, ROs, employees, creditors, and lessors. The Select Agent Program requires pre-approval for destruction of agents, pre-approval for transfers of agents, the maintenance of accurate records, and many other compliance tasks. Due to the way the Select Agent Program regulations are written, a defunct company can actually shift liability for select agents to any number of individuals. Directors, officers, ROs, employees, creditors, and lessors should contact Goldberg Legal Services to guard against liability.