PHRMA

It is unfortunate that some members of Congress are pushing unsafe prescription drug importation schemes at a time when tens of millions of Americans are gaining access to affordable health care coverage, services and treatments through the new health care reform law.

Exposing our closed, carefully-regulated pharmaceutical distribution system to imported medicines raises the risk of counterfeit or substandard drugs creeping into our nation’s medicine supply. Even the Food and Drug Administration (FDA), under both Democratic and Republican administrations, has stated that it could not assure the safety of imported medicines from foreign countries and that they would present a risk to public health.

Countless reports also suggest that the worldwide counterfeit threat is knocking at America’s door. In fact, the Washington Post highlighted the counterfeit threat by stating that, “counterfeit drugs are the latest – and potentially most dangerous – front in the long-running battle against intellectual-property crimes…[Out of all] counterfeit products seized by customs officials last year, pharmaceuticals are one of the fastest-growing categories.”

Outside of the U.S., where there is largely an open drug supply system, the counterfeit problem is growing worse by the day. In fact, a leading European Union (EU) commissioner, Gunter Verheugen, was quoted saying that, “The number of counterfeit medicines arriving in Europe…is constantly growing. The European Commission is extremely worried. In just two months, the EU seized 34 million fake tablets at customs points in all member countries. This exceeded our worst fears.” Commissioner Verheugen was further quoted in the German newspaper Die Welt stating that, “Every faked drug is a potential massacre. Even when a medicine only contains an ineffective substance, this can lead to people dying because they think they are fighting their illness with a real drug.”

The alarming rate of counterfeit products being manufactured and sold around the world poses great challenges to federal agencies such as FDA and Customs and Border Protection (CBP), which falls under the Department of Homeland Security. In fact, according to CBP officials, seizures of counterfeit imports coming into the U.S. rose by 27 percent – worth about $200 million in domestic value – in 2007. Two years later, in 2009, CBP officials and U.S. Immigration and Customs Enforcement (ICE) officials made over 14,800 seizures of counterfeit and pirated goods with a total domestic value of $260.7 million. For this reason, PhRMA believes that Congress should continue to maintain – not weaken – FDA’s closed drug supply system and also ensure that CBP and FDA have the resources to seize potentially dangerous and counterfeit products at our nation’s borders.

For all of these reasons – and many more – we believe that Congress should not consider proposals that threaten patient health and safety. In the meantime, America’s pharmaceutical research and biotechnology companies – whose lifeblood is the safety and integrity of the products they develop – will remain committed to helping federal agencies protect and prevent the proliferation of counterfeit medicines in the U.S.

Until 2014, when all Americans can access high-quality and affordable healthcare coverage, there are safer alternatives that can help patients access medicines:

• The Medicare prescription drug program is working and has helped more than 40 million seniors and America’s disabled save on average $1,200 a year on their medicines.
• The Partnership for Prescription Assistance (PPA) – a program spearheaded by America’s pharmaceutical research companies – has helped more than 6.5 million uninsured and underinsured Americans access programs that provide free or nearly-free medicines. Patients can access more information about PPA by calling a toll free number, 1-888-4PPA-NOW or going online at www.pparx.org.

Visit www.buysafedrugs.info for more information about counterfeit medicines and the dangers of importation.