Open Letter to the Public from John J. Castellani

Have you ever asked your doctor or pharmacist if your medicine is real or counterfeit? Probably not, nor should you have to. Unfortunately, such questions may become commonplace if proposals move forward that could open up the U.S. drug supply system to unapproved foreign products.

American patients currently enjoy peace of mind knowing that their prescription medicines are safe and effective, as determined by the US Food and Drug Administration (FDA), and not counterfeit. While every drug carries both benefits and risks, patients in the U.S. can generally be confident in the authenticity of their medicines.

In the U.S., unlike Europe, we’ve been fortunate that we haven’t experienced an explosion of growth in counterfeit medicines. For example, in 2008, counterfeit medicines seizures rose 118 percent in the European Union (EU), and drugs to treat hypertension, osteoporosis and high cholesterol were among the drugs seized, according to a report by the European Commission. What’s more, 34 million counterfeit pills were seized at the EU borders over a two month period in 2008. Among those 34 million counterfeit pills were fake cancer, cholesterol and anti-malaria pills.

So why is the U.S. less vulnerable to the global counterfeit medicine epidemic? Unlike the EU and other countries around the world, the U.S. drug supply system is a closed system - this means that foreign medicines not approved by FDA are prohibited from entering the U.S. to help ensure that American patients are protected from the global counterfeit medicine threat.

Many people ask why our U.S. prescription drug supply system is closed, especially when we live in a globalized world where we can buy clothing and food from other countries.

The reason why is simple: In the 1980’s, when the U.S. drug supply was open to foreign medicines, many women taking birth control were getting pregnant. After many complaints and 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. This bill 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, healthier, and more productive lives.

A lot has changed since the 1980’s, including the introduction of the worldwide web. Unfortunately, criminal networks around the world have become increasingly sophisticated and are taking advantage of millions of patients around the globe by selling cheap counterfeit drugs on Internet sites, many of which masquerade as legitimate pharmacies and display a Canadian flag. Countless studies have shown that these rogue online pharmacy sites serve as a clearinghouse of unapproved and dangerous counterfeit drugs that unsuspecting consumers can buy without a valid prescription.

Fortunately, over the past few years, significant steps have been taken by the U.S. government, pharmaceutical research companies and other health care stakeholders to adapt to the new reality that has been shaped by our increasingly globalized economy. Efforts to crack down on counterfeit medicines have certainly helped shield Americans from counterfeits, but more must be done.

In a recent report to Vice President Joe Biden and the Congress, the Counterfeit Pharmaceutical Inter-Agency Working Group stated that, “it is difficult to quantify the harm caused globally by counterfeit drugs, it is clear they pose a significant and growing threat to health at both the individual and the community levels, potentially causing treatment failure or death...”

The report provided specific examples of the threat: A U.S. company’s vaccine for pneumococcal bacteria distributed in El Salvador was missing the essential ingredient - providing families with a false sense of disease protection. And, counterfeits of two cancer drugs were illegally manufactured in China and Indonesia and were devoid of the critical active ingredient for the treatment of cancer.

The Working Group outlined several recommendations for Congress to consider to help ensure that illegitimate and contaminated medicines do not enter the pharmaceutical supply chain. One recommendation we’ve been very supportive of over the years is increasing the jail sentence for criminals caught selling counterfeit drugs. The average jail time for counterfeiters is three years but we believe the minimum sentence should be 20 years.

I believe the biggest takeaway from all of this information I have presented is that we must not rest on our laurels and that we must do everything we can to root out criminal networks and put a stop to the global counterfeit medicine trade. Rest assured, America’s biopharmaceutical research companies will continue to work with our public and private partners in the fight against this growing epidemic so that we can help shield patients and protect the safety and integrity of our closed drug supply system.

John J. Castellani
President and Chief Executive Officer
Pharmaceutical Research and Manufacturers of America