Members Portal | Contact Us

News

Imports Aren’t the Answer to High Drug Prices

By The Honorable Bob Franks, President, HealthCare Institute of New Jersey

Bridgewater, NJ, October 15, 2007 — Fueled by recent headlines about tainted produce, pet food, seafood, toothpaste and even children’s toys, Americans have good reason to worry about the safety of imported goods.  At the root of this phenomenon is the failure of the FDA’s import and safety system, which has sparked fear and a loss of consumer confidence in the security of our purchases.

In recent stunning testimony before Congress, the U.S. Food and Drug Administration acknowledged it does not have the manpower to regularly inspect plants overseas that make prescription drug medicines and the bulk ingredients associated with them. Because of the shortage of staff and resources, the deputy director of the FDA’s Office of Regulatory Affairs, Steve Solomon, told a House Energy and Commerce subcommittee that realistically, they can only inspect “several hundred” foreign drug-manufacturing facilities a year.

The fact is that there are almost 3,000 such facilities in foreign countries. Moreover, the shortage of FDA inspectors means that our government doesn’t have the resources to locate and close down facilities abroad that are manufacturing counterfeit, adulterated or dangerous medicines.

Even worse, FDA Deputy Commissioner Randall Lutter told the congressional panel that in many cases the facilities of overseas companies that export medicines to America have not been inspected by the FDA for as long as 10 years. Lutter also confirmed that the FDA does not have any permanent inspectors in either China or India, both growing sources of pharmaceutical activity. For anyone who values the security of the medicines they take, this situation should be a chilling reminder of the dangers of importation.

Legitimate research-based pharmaceutical companies have an important stake in this debate.

Drug makers are more sensitive than anyone when it comes to the safety and integrity of their own products. Processes are developed and maintained which ensure the purity and potency of the medicines they market. Those processes protect the product from the drug development stage through the distribution process.

However, while manufacturers abide by numerous quality control mechanisms – stateside and abroad – who is to say that an unscrupulous manufacturer abroad could not circumvent the system and taint our drug supply?

New Jersey Congressman Frank Pallone, who co-sponsored last week’s hearing in Washington, is right to say that “American consumers should be able to trust that the products they purchase have been properly regulated and inspected, thereby making them safe.” We commend him on taking the lead in this important policy debate.

Unfortunately, some patients have been lulled into a false sense of security that importation is absolutely safe and is the answer to high drug prices. To that, we say patients should not have to turn to dangerous foreign sources to get their medicines.

The pharmaceutical industry has a wide variety of Patient Assistance Programs in place to help low-income, uninsured patients. In New Jersey alone, over 200,000 patients have gained access to free or nearly free medicines through the Rx4NJ program. Nationwide, over 4.2 million patients have been helped by the pharmaceutical industry’s Partnership for Prescription Assistance.

Importation is not the answer. Unscrupulous manufacturers can ship their products all over the world. The United States could be flooded with unsafe and counterfeit drugs from many different countries. These would include substandard drugs that won’t lower your blood pressure, cure your heart arrhythmia, fight your cancer or improve your condition in any way. And, in the end, reliance on an unregulated and dangerous system diverts our attention away from the greater challenge of helping more people to secure the medicines they need.

Bob Franks, a former member of the United States House of Representatives, is president of the HealthCare Institute of New Jersey, a pharmaceutical industry trade organization.