- The Washington Times - Wednesday, October 19, 2005

After his recently confirmed Food and Drug Administration commissioner suddenly resigned, President Bush wisely tapped Dr. Andrew von Eschenbach to fill the slot.

Dr. von Eschenbach knows how to think big. As director of the National Cancer Institute since 2002, he challenged himself, his colleagues, and the medical world to transform cancer into a chronic, rather than a lethal, disease by 2015.

His ambition raised some skepticism but sharply focused NCI attention on the applied research needed to beat the disease.

Now Dr. von Eschenbach faces a bigger battle: taking the helm of an FDA facing sea changes in the U.S. health-care system.

Charged with ensuring oversight of about 30 percent of our economy, his decisions will affect not just livelihoods, but lives.

A more pressing issue is the growing problem of counterfeit drugs — those dangerous imposters of patented products that provide incorrect dosages, sugar pills or deadly cocktails.

Counterfeit prescription medicines is a global problem. Canadian federal authorities recently charged an Ontario pharmacist with selling counterfeit Norvasc heart medication after five customers who bought it died of heart attack or stroke. And the Royal Canadian Mounted Police announced multiple investigations remain open in other parts of the country.

The World Health Organization estimates 8 percent to 10 percent of pharmaceuticals sold worldwide are counterfeit. And this is increasing. Counterfeit sales are expected to reach $75 billion by 2010 — up 92 percent from this year.

This represents a significant worldwide threat to public health. European parallel trade, the ubiquity of international travel and Internet shopping and plain old smuggling, makes counterfeit drugs a clear and present danger to the United States. A related issue the FDA must handle is illegal drug re-importation.

Throwing off FDA authority to oversee medicines’ quality and safety of medicines greatly increases the risk patients will obtain counterfeit drugs. Canada and Europe may have competent drug safety authorities, but lax customs and fraudulent advertising mean “Canadian” pills in U.S. mail boxes could have come from anywhere — from China, for example, whose fake drugs the government estimates cause about 192,000 deaths yearly. Shoring up drug safety must be at or near the top of Dr. von Eschenbach’s agenda. Long-term regulatory reform will be equally important.

Almost 15 years and more than $802 million are now needed by a pharmaceutical company to see through approval that minority of drugs that get FDA consideration. Dr. von Eschenbach should give a high priority to streamlining this. A shorter cycle would get new lifesaving drugs to market faster and more safely, while lowering manufacturers’ costs.

Consumers play an ever-growing role in their own health care. So another “must do” item on Dr. von Eschenbach’s list is patient empowerment through better communications.

In the last few years, standard risk warnings in advertisements and on labels have become too dense and complex — and increasingly confuse and worry consumers. The FDA can require the use of clear English. “In compliance” and “user-friendly” should not be mutually exclusive terms.

These battles, among many others, will show the world (not to mention the U.S. Senate) that Dr. von Eschenbach has the right stuff. As anyone who has followed his career at the National Cancer Institute will attest, cancer research is not just a calling, but involves a disease he has personally beaten three times. If anyone can tackle 21st century drug safety, it is he.

Peter J. Pitts is senior fellow for health care studies at the Pacific Research Institute and the former Food and Drug Administration associate commissioner for external relations.



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