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The Honolulu Advertiser
Posted on: Thursday, May 1, 2008

Heparin case shows FDA must revamp game plan

Disturbing news of contaminated batches of the drug heparin, a blood thinner commonly used by dialysis patients, has once again raised sobering questions about the Food and Drug Administration and the safety of imports.

In this case, the contaminated drug was linked to at least 81 deaths in the United States, and was traced back to ingredients produced in China.

Even more appalling: The FDA's hypothesis is that the contamination was deliberate, with some batches of the drug containing more than 30 percent of the contaminant.

This information and the heart-wrenching testimony of those who lost loved ones due to the tainted drug was put before a congressional committee Tuesday.

The hearing underscored gaping holes in our import safety net that had already been laid on the table in previous FDA-related investigations into a spate of poisonous imports — from lead-tainted Chinese-made toys, to pet foods laced with dangerous doses of melamine in wheat gluten imported from China, to toxic toothpaste, also made in China.

It's now up to Congress and the Bush administration to make changes immediately to improve federal oversight and ensure manufacturers are held accountable for the safety of their products.

First, both the Consumer Product Safety Commission and the FDA are in dire need of more funding and additional staff to meet their growing responsibilities, which now include a focus on foreign production and products.

Today's global economy demands that regulatory agencies — particularly the FDA — do more to ensure the safety of imports. More than 80 percent of the active ingredients in drugs are now produced outside of the United States, a sizeable and growing portion from China and India. Yet the FDA can only afford to inspect foreign plants every 13 years; only 11 percent of foreign drug plants are actually inspected in any given year.

It's critical that the FDA take a more aggressive approach to these inspections. Indeed, members of Congress sharply criticized the FDA for not inspecting the Changzhou SPL plant before approving it as a supplier of heparin, and rightly so.

Congress must find a sensible way to fund these inspections. Encouragingly, both Republicans and Democrats now agree on the urgency of increasing the FDA's budget.

While the number of drug imports has doubled, the number of FDA inspectors declined 35 percent, said Dr. Janet Woodcock, director of the FDA's drug center.

The FDA would need another $325 million to conduct inspections of drug plants every other year, as suggested by drug safety experts; $225 million of that would go toward inspections of foreign plants, she said. The FDA this year will spend $11 million on inspections of foreign drug plants.

One plan, a draft bill now making its way through Congress, would impose a $2,000 user fee on importers of drugs, food and other products to fund more FDA oversight. That plan would draw in an estimated $600 million, more than doubling the FDA's current food safety budget. It deserves careful consideration.

But those user fees will more than likely be passed along to consumers, who, like manufacturers, look to foreign-made products and production as a cost-cutting measure. That means any discussion of fee increases must include safeguards to protect people from being priced out of getting the food and medications they need.

And on the policy front, the Bush administration must proactively pave the way with agreements that allow open inspections of foreign factories.

But the accountability does not fall solely on the FDA. American pharmaceutical manufacturers, including heparin manufacturer Baxter International, that take advantage of lower-cost ingredients and dirt-cheap production costs must also be held responsible for the safety of their products.

The cluster of problems with imports, particularly from China, also makes a strong case for more truth in labeling — consumers have the right to know the origin of the ingredients in drugs and other products they purchase.

Americans need to have confidence in the safety of food and drugs they consume. Anything less means our regulatory system, funded by hard-earned tax dollars, has failed in its most fundamental of responsibilities.That is just unacceptable.