In a recent example of prosecutions of physicians for using adulterated or misbranded drugs and devices, a Tampa area oncologist was sentenced on August 7, 2017 to almost 6 years in prison for using unapproved, foreign-sourced chemotherapy drugs.  According to the Indictment, Dr. Norbergs ordered the drugs from foreign, unlicensed distributors for use in her practice.

According to the government, the distributor involved had a reputation for selling counterfeit product that lacked the active ingredient purportedly contained in the drug.  The government alleged that Dr. Norbergs learned of this fact, but continued to order from the distributor.  The government further alleged that Dr. Norbergs purchased unapproved foreign-sourced and foreign-labeled drugs from at least one other overseas distributor.

The Indictment charged the doctor with violations of the FDA and Customs laws, as well as health care fraud and mail fraud in connection with the submission of claims to Medicare for the use of the unapproved drugs.  The Food, Drug and Cosmetics Act prohibits the introduction of unapproved, misbranded or adulterated drugs into interstate commerce.  Medicare does not cover the use of unapproved drugs and devices in most cases, so the government alleged that Dr. Norbergs committed health care fraud in connection with the submission of claims for the drugs in question.

The potential patient harm aspect of this case — an oncologist treating cancer patients with questionable drugs — certainly garnered the attention of the government, but the importation and/or use of any unapproved drug or device can result in enforcement action by the government irrespective of the potential for patient harm.  If you are a healthcare provider and you are not sure about the source or approval status of the products you are using, we strongly encourage you to seek the advice of competent regulatory counsel.

The attorneys as Nicholson & Eastin, LLP regularly assist our clients with FDA and health care fraud enforcement matters.  Please do not hesitate to contact us for a consultation.