From The Riverside Press-Enterprise ...
For safety's safe, keep out drug imports
Sunday, February 24, 2008
By PETER PITTS
A couple of weeks ago, the Government Accountability Office delivered an alarming message to a congressional panel -- the Food and Drug Administration lacks the resources to ensure the safety of the nation's food, drugs and medical devices.
Congress has vowed to fix the FDA. It plans to boost its funding, which is a good start. But those efforts will be more than undermined if Congress legalizes drug importation, which it may try to do this month. Attempting to screen imported prescription drugs would stretch the FDA's abilities to their breaking point.
Just as the agency's workload has surged, its budget has shrunk. The FDA's congressional appropriations have declined $400 million in inflation-adjusted dollars in the last 14 years. But its responsibilities have increased substantially, thanks to more than 100 congressional measures expanding its regulatory scope over the last two decades.
Those budget cuts translate to 1,311 fewer workers today overseeing an ever-expanding territory. About 80 percent of all drugs sold in the U.S. are manufactured abroad, but the FDA has only 380 inspectors -- a decline of 28 percent since 2003.
Consequently, the FDA cannot inspect the factories of foreign drug makers as frequently as it should. According to the GAO, only 7 percent of the more than 3,000 foreign drug factories registered with the FDA are inspected in any given year -- which means that more than 13 years could pass between inspections.
By contrast, domestic drug makers receive at least one FDA inspection every two years.
The FDA's inability to monitor the 714 Chinese drug makers subject to agency rules is especially worrisome. Just 13 of them -- 1.8 percent -- were inspected in 2007, according to the GAO.
That's not comforting news for American patients. The World Health Organization estimates that 10 percent of the world's drug supply is counterfeit, and many, if not most, of these fakes are made in China.
For example, it was recently reported that a Chinese drug company manufactured an anti-leukemia drug that left nearly 200 Chinese injured. Ordinarily, this would not have raised headlines in America. But the Chinese firm in question was also the sole supplier of the abortion pill RU-486 to the U.S.
Given how few foreign inspections the FDA conducts -- especially in China, where the risks are greatest -- the likelihood of a medical calamity befalling Americans is far too high. How can Congress possibly believe drug importation would be safe? Foreign-made pills would flood U.S. borders.
That means even more foreign packages potentially containing fake or harmful drugs will enter the country without being inspected. The John F. Kennedy Airport Mail Facility receives about 40,000 foreign shipments thought to contain drugs each day. Only 500 to 700 of them are inspected. It makes no sense to expand inspection responsibilities when the FDA can't cover its current ones.
Approving the drug-importation bill might push the agency over the edge. Now is not the time to saddle it even further with the impossible task of adequately screening drug imports. Americans can't afford it.
Peter Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.
For safety's safe, keep out drug imports
Sunday, February 24, 2008
By PETER PITTS
A couple of weeks ago, the Government Accountability Office delivered an alarming message to a congressional panel -- the Food and Drug Administration lacks the resources to ensure the safety of the nation's food, drugs and medical devices.
Congress has vowed to fix the FDA. It plans to boost its funding, which is a good start. But those efforts will be more than undermined if Congress legalizes drug importation, which it may try to do this month. Attempting to screen imported prescription drugs would stretch the FDA's abilities to their breaking point.
Just as the agency's workload has surged, its budget has shrunk. The FDA's congressional appropriations have declined $400 million in inflation-adjusted dollars in the last 14 years. But its responsibilities have increased substantially, thanks to more than 100 congressional measures expanding its regulatory scope over the last two decades.
Those budget cuts translate to 1,311 fewer workers today overseeing an ever-expanding territory. About 80 percent of all drugs sold in the U.S. are manufactured abroad, but the FDA has only 380 inspectors -- a decline of 28 percent since 2003.
Consequently, the FDA cannot inspect the factories of foreign drug makers as frequently as it should. According to the GAO, only 7 percent of the more than 3,000 foreign drug factories registered with the FDA are inspected in any given year -- which means that more than 13 years could pass between inspections.
By contrast, domestic drug makers receive at least one FDA inspection every two years.
The FDA's inability to monitor the 714 Chinese drug makers subject to agency rules is especially worrisome. Just 13 of them -- 1.8 percent -- were inspected in 2007, according to the GAO.
That's not comforting news for American patients. The World Health Organization estimates that 10 percent of the world's drug supply is counterfeit, and many, if not most, of these fakes are made in China.
For example, it was recently reported that a Chinese drug company manufactured an anti-leukemia drug that left nearly 200 Chinese injured. Ordinarily, this would not have raised headlines in America. But the Chinese firm in question was also the sole supplier of the abortion pill RU-486 to the U.S.
Given how few foreign inspections the FDA conducts -- especially in China, where the risks are greatest -- the likelihood of a medical calamity befalling Americans is far too high. How can Congress possibly believe drug importation would be safe? Foreign-made pills would flood U.S. borders.
That means even more foreign packages potentially containing fake or harmful drugs will enter the country without being inspected. The John F. Kennedy Airport Mail Facility receives about 40,000 foreign shipments thought to contain drugs each day. Only 500 to 700 of them are inspected. It makes no sense to expand inspection responsibilities when the FDA can't cover its current ones.
Approving the drug-importation bill might push the agency over the edge. Now is not the time to saddle it even further with the impossible task of adequately screening drug imports. Americans can't afford it.
Peter Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.
