Handling Pharmaceutical Investigations

My name is Michael Alexander, and I’m an attorney in the Brown and Fortunato Health Care 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, I should never do anything to jeopardize my law license as an attorney. My license is my livelihood.

The same is true for healthcare 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 & 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 will 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 the 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 and preparing any responses to the government and then 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 represent clients at any hearings.

So whether you’re looking for 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 & Fortunato have the regulatory experience to help you at each step of the process.