$16 Million in FL Pharma Drugs Gone Wrong

Sharon Roberts AttorneyIn April of this year, the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Florida requested that U.S. Marshals seize over $16 million dollars worth of prescription drug products that had not yet been approved from Stratus Pharmaceuticals, Inc., of Miami, Florida. These prescription drug products had been marketed and distributed in spite of their lack of approval, which is what prompted this large-scale seizure.

The products removed during this operation included topical treatments including; antibiotic skin cleansers, ointments for wounds, creams and gels to treat skin conditions as well as analgesic eardrops and a solution for excessive sweating. As of the time of that seizure in April, none of those products had prove to be safe or effective in terms of their intended use. The FDA then recommended that people who had taken these drugs consult with their physician or pharmacist about finding alternate treatment plans. And discontinuing use of these unapproved drugs.

Cynthia Schnedar, who is the director of the Office of Compliance within the FDA’s Center for Drug Evaluation and Research remarked,“Companies that market unapproved drugs are placing consumers at risk because the products may not be safe, effective or made using quality manufacturing practices.” She goes on to state, “The FDA is committed to protecting consumers and will continue to take actions against companies that do not meet these standards.”

Initially, the office of the U.S. Attorney launched a formal complaint on behalf of the FDA in the U.S. District Court for the Southern District of Florida, claiming that these drugs and drug products were unapproved and misbranded, according to the Federal Food, Drug, and Cosmetic Act.

This assertion came on the heels of an inspection performed by the FDA in late 2014 that exposed this practice of marketing and distributing pharma drugs that had neither undergone nor been approved by required FDA drug application process.

This approval process from the FDA is employed to ensure the safety and effectiveness of drug products that are administered to patients. Medical drugs that do not undergo this extensive process may be ineffective or even harmful to those taking them.

The seizure itself of these unapproved drug products was orchestrated in a manner that followed the stated policy outlined in the FDA’s Marketed Unapproved Drugs Compliance Policy Guide. This guide states explicitly that any product that is being marketed illegally (and the person or people responsible for this) is subject to enforcement from the FDA at any time.

It is events like this seizure that bring to light the importance of maintaining strict compliance with all codes, laws and guidelines relevant to pharmaceutical drug products at every level of the supply chain. To learn more about this event, see the release from the FDA.