Handling Pharmaceutical Investigations – Michael Alexander

My name is Michael Alexander and I’m an attorney in the Brown and Fortunato Healthcare Group, and I represent pharmacy clients in various regulatory compliance and related matters.

Now, as a young attorney, I had a mentor tell me that no matter what I do, I should never do anything to jeopardize my law license. As an attorney, my license is my livelihood.

The same is true for health care providers, including those of you in the pharmacy space. The revocation, suspension, or discipline of your license, permit, or registration can have a severe detrimental impact on your business and livelihood.

Now, one of the most stressful times many of my clients face is when they’re the subject of a DEA, board of pharmacy, or other regulatory inspection or investigation. These are often unannounced, and to be honest, no one is perfect. Regulators can almost always find something that needs to be addressed.

At Brown of Fortunato, we assist clients in preparing for and walking through inspections and investigations in two main areas. First, we assist clients in developing, reviewing, and putting in place compliance programs. A robust, comprehensive compliance program is your best shield in an investigation or inspection for a number of reasons.

First, it’ll prevent most issues from coming up in the first place. Second, a well-designed compliance program will catch any issues that do arise early. Last, if any issues are identified in an inspection, the existence of a compliance program that the pharmacy adheres to goes a long way in generating goodwill and demonstrating an attitude of compliance to the government.

Next, we walk with clients hand in hand from day one of an investigation, even while inspectors are still on site, through final resolution.

We serve as the primary point of contact with the government.

We assist the client in conducting an internal review, preparing any responses to the government, and in putting any corrective measures in place.

We evaluate the government’s claims. We help the client assess potential exposure.

We negotiate the terms of any agreements, and if necessary, we will represent clients at any hearings.

So whether you’re looking forward and want to prevent issues from coming up in the first place or you’re already in the midst of an investigation, the attorneys at Brown and Fortunato have the regulatory experience to help you at each step of the process.

This article is for informational purposes only and does not constitute legal advice or establish an attorney-client relationship. This article was prepared on a specific date, and the law may have changed since it was written. You should contact your attorney to obtain advice with respect to your specific legal issue and needs.

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