Typically, you would expect pharmaceutical companies to focus the bulk of their practice on creating and developing new and effective drug treatments. However, research suggests that their marketing and advertising budget exceeds that of their research and development program. Pharmaceutical companies and sale representatives are expected to follow strict ethical guidelines. Failure to do so could result in both civil and criminal penalties.
Pharm Sales & Marketing:
One major method that pharmaceutical companies often do (which is in violation of the law) is to sell drugs ‘off-label.’ This means that the FDA has approved a drug for some very narrow use, such as ADHD, but the drug company actively attempts to get doctors to use the drug for another use, like depression or dementia. Claims regarding off-label marketing have been settled with the government from anywhere between $300 million and $1.4 billion. Although these seem like hefty fines to pay, pharmaceutical companies make some of the largest profit margins in the world. There is little to no deterrent, despite the fact that the U.S. government has stepped up efforts to prosecute these behaviors. With that in mind, there can be no doubt that penalties will only increase in severity. It is a good idea to obtain an attorney or law firm with vast experience and knowledge in healthcare fraud and defense to guide you and prevent any criminal wrongdoing.
First, attorneys will be able to help companies develop some internal investigation and auditing programs to root out problems in advance of any government involvement. These investigations should also include written policies and procedures to aid the company in handling any questionable behavior by its employees and sales representatives. In the event an investigation has already begun without the company’s knowledge – and they find out after being subpoenaed – an attorney can pressure the government to reveal what the issue is. In this way, the company can act more quickly to stop and prevent future acts from occurring, rather than wait for a sometimes inefficient government investigation to complete, all while the behavior continues (or worsens). These attorneys should be well-versed in all the regulatory, federal and statutory schemes that affect pharmaceutical companies and marketing representatives. The best way to be compliant is to hire someone who knows the system in and out, and a competent attorney will be able to do that for you.
Finally, if you are the subject of a criminal investigation and you end up being prosecuted (or even convicted) your best shot at a fair and reasonable outcome is to hire a strong legal advocate. They will be able to access documents from the prosecution and understand their position. They will also be in a position to negotiate on your behalf, potentially reducing any penalty you receive (like lowered jail-time, or just community supervision) as well as lowering any financial penalties you might have to pay out. The government, being hypervigilant in its crackdown on healthcare fraud, can easily misinterpret legitimate business plans and marketing tactics. Hiring an attorney will be able to expose any error in judgment (on either side), and protect you, getting the best possible outcome for you under the circumstances.