America has the safest drug supply chain in the world. Historically, that has been more than a proud boast; it has been a fact. Patients getting medicines from their pharmacists and doctors — whether brand name or generic — have been able to count on the fact that the drug in the bottle matches what’s on the label, and is genuine. That is the way our supply system should work, and every American patient should be able to rely on this system to ensure their health and safety. Unfortunately, the scourge of counterfeit medicines is no longer someone else’s problem.


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Inside This Issue - Opinion

Integrity of drug supply chain must be protected

October 22nd, 2012
by Ralph Neas, GPhA, and John ­Castellani, PhRMA

America has the safest drug supply chain in the world. Historically, that has been more than a proud boast; it has been a fact. Patients getting medicines from their pharmacists and doctors — whether brand name or generic — have been able to count on the fact that the drug in the bottle matches what’s on the label, and is genuine. That is the way our supply system should work, and every American patient should be able to rely on this system to ensure their health and safety. Unfortunately, the scourge of counterfeit medicines is no longer someone else’s problem.

It is not limited only to patients in other countries. The pirates and fast-money crooks counterfeiting prescription drugs increasingly see our borders as a new “zone of opportunity” instead of an impediment to their illegal schemes.

The scourge of counterfeit medicines is no longer someone else’s problem.

And the risk inflicted by fake medicines is driven even higher as an increasing number of Americans are buying their drugs from unlicensed Internet pharmacies operating outside the regulated U.S. supply chain.

Alarmingly, many of these online “pharmacies” do not even require a prescription to dispense the medicine. Enterprising criminals see those unregulated Internet operations as the doorway into the U.S. market for their substandard and counterfeit wares.

Food and Drug Administration Commissioner Margaret Hamburg identified counterfeit medicines as a public health crisis that is growing in sophistication and prevalence across the globe. She emphasized the need to “work together to stay ahead of the many avenues that criminals are finding that are putting the health and safety of American citizens at risk.” With her recent announcement of the FDA’s BeSafeRx program, Hamburg unveiled a new tool to educate the public and empower consumers with information about the dangers of fake online pharmacies.

While it may surprise some, our companies — both brand and generic — have found a great deal of common ground on many issues, including the need to keep the U.S. drug supply chain safe and secure. This year we have worked closely with Congress and other stakeholders to develop a system to track prescription drugs as they move through the supply chain.

We also have endorsed stronger penalties for drug counterfeiting crimes and together have supported the recently passed Safe Doses Act, which provides law enforcement with more tools to curb criminal activities related to medical products.

We are fortunate that here at home the crisis of counterfeit medicines has not yet become rampant. Because of our regulatory structure, which includes laws that prevent foreign companies from selling drugs in the United States without FDA approval, we have been able to ensure patients that drugs purchased at local pharmacies and through licensed websites can be trusted.

But we cannot let down our guard. At last week’s Partnership for Safe Medicines annual Interchange Conference in Washington, D.C., public health leaders from here and abroad explored broader global collaboration to keep patients safe from counterfeit or substandard medicines. While there is much more to be done, the international community is demonstrating its commitment to sharing information on counterfeiters, enacting effective standards and reviews, and limiting the opportunity for counterfeit drugs to get into the global pipeline.

Both the research-based biopharmaceutical and generics industries are collaborating with U.S. and foreign regulators and law enforcement agencies to seek new areas of cooperation. Maintaining the public’s confidence in the integrity and safety of our products is of paramount importance; eradicating the counterfeit drug trade is a top priority.

Of course, there also is a role for patients and families to play in this effort. While some counterfeit drugs are nearly indistinguishable from the real thing, many have visual clues that can tip us off that they are not the real thing. It is important that we all recognize the physical traits of the medicines that our families take, including the appearance, taste, texture, reactions and packaging.

And we all should understand the importance of purchasing our prescriptions from safe, licensed sources. A little research and education about the prescription medications our families are taking can go a long way.

The United States has always been a place where the drug supply can be trusted. Working together — industry, consumers and regulators — we must keep it that way.

RALPH NEAS is president and chief executive officer of the Generic Pharmaceutical Association (GPhA). JOHN CASTELLANI is president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA).

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