The FDA has estimated that medications with a value of around $700 million entered the United States from Canada alone in 2003, and an equivalent amount may be entering from the rest of the world.
Explore This IssueOctober 2012
FDA Mission Is Drug Safety
For medications that are not controlled substances, the FDA is the lead agency. Although the DEA and the Department of Health and Human Services (HHS) deal largely with the illegal use of drugs, the FDA’s mission is drug safety.
“The FDA cannot ensure the safety and effectiveness of products that are not FDA approved and come from unknown sources and foreign locations, or that may not have been manufactured under proper conditions,” said Sarah Clark-Lynn, a spokesperson from the FDA’s Office of Public Affairs. “These unknowns put a patient at risk if they cannot be sure of the product’s identity, purity and source.”
One of the concerns in this area is counterfeit or fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right ingredient but at less-than-therapeutic or even fatal doses. Medications can also degrade if not stored and transported in compliance with established standards.
Misbranding is also a problem. This occurs when the labeling on the medication does not correspond to the requirements of the law. It ranges from a type size that is too small to improper directions for taking the drug.
“Just because medications have been approved by another country’s regulators does not automatically mean they are okay for use in this country,” said Dr. Mollo. “For example, the U.S. has high standards for bioequivalency in generic medications. It can be legal in one country and still not acceptable for use in this one.”
HHS Also Has Concerns
The Office of Inspector General (OIG) for the HHS is another group that may be involved in drug diversion if the scam includes payment from either Medicare or Medicaid.
“We are brought in when the medication is paid for using funds from Medicare or Medicaid sources,” said Ryan Lynch, assistant special agent-in-charge of the Office of Investigations at the OIG’s Tampa office. “Sometimes, the patient obtains the medications using a legitimate prescription and then sells them on the street. In other instances, there may be collusion between the patient, doctor and/or their pharmacy.”
The OIG looks for certain indicators that the physician knows the diversion is taking place. Among these are the charging of exorbitant fees: as much as $500 for a routine visit or for multiple services that they did not render.