While Americans, for the most part, have been protected from counterfeit medicines because of legislation passed by Congress to strengthen our drug supply, we believe specific measures must be considered to fortify our borders, create uniform track and trace standards and crack down on criminal activity related to counterfeit medicine crimes.
Recently, the Senate passed the Counterfeit Drug Penalty Enhancement Act, which would create national jail sentencing guidelines for criminals in the counterfeit medicine business. This is a step in the right direction.
PhRMA has long advocated for increasing jail sentences for counterfeit medicine crimes from the national average of three years to at least 20 years. It is simply unacceptable that criminals caught selling street drugs face heftier sentences than criminals selling counterfeit medicines, which can be harmful – and even deadly – to patients.
If you ask any one of our company security experts on the front line in the war against counterfeit medicine crimes, they will tell you that international criminal networks have become extremely sophisticated in replicating – almost to a tee – not only the color, shape and size of a particular medicine, but also the labeling and packaging that is used to ship the treatments.
The reality is that criminals often adapt just as quickly as our companies’ anti-counterfeiting technologies evolve to help prevent diversion of our products from the regulated supply chain.
Unfortunately, there is currently a patchwork system of state laws that attempt to put into place mechanisms that would electronically track and trace packages containing medicines throughout the supply chain – which could be utilized in such cases when counterfeiting is suspected.
We believe the right approach is developing a national standard that can provide regulators, health care professionals, wholesalers, pharmacists and others with the capabilities to track and trace any package containing prescription medicines to ensure authenticity. We also believe that increasing licensure requirements for wholesaler distributors could help prevent the supply chain from being compromised.
History has taught us many important lessons about our nation’s vulnerabilities but one particular incident in the 1980’s, when the U.S. drug supply was open to foreign medicines, stands out as a reason why Congress must maintain a closed drug supply system.
At the time, many women taking birth control were getting pregnant. After many investigations, it was discovered that they were taking counterfeit pills of foreign origin. Members of Congress took action to help prevent this from happening again and passed a bill called the Prescription Drug Marketing Act.
The implementation of this law effectively closed the U.S. drug supply system to help prevent foreign counterfeit drugs from getting in the hands of American patients who rely on safe medicines to live longer and healthier lives. There have been some advocates who want to open this system up, but this would only put patient safety at risk – as we have seen in the European Union, where many counterfeit seizures are due in large part to the open drug supply system between member states.
What it all boils down to is that Americans shouldn’t have to second guess whether their medicine is real when they go to their neighborhood pharmacy. For this reason alone, Congress and the Administration should make the war against the growing worldwide counterfeit medicine threat a continued national priority so that we can help shield American patients, root out criminal networks and protect the safety and integrity of our closed drug supply system.
Castellani is the President and CEO of the Pharmaceutical Research and Manufacturers of America.