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Hearing of the Senate Health, Education, Labor and Pensions Committee on FDA's Ability to Keep America's Families Safe


Location: Washington, DC

Hearing of the Senate Health, Education, Labor and Pensions Committee on Restoring FDA's Ability to Keep America's Families Safe


Senate Health, Education, Labor and Pensions Committee

(As Prepared for Delivery)

This hearing is about prevention: how do we prevent tragedies such as Heparin, or the continuing reports of unsafe spinach, peanut butter, breakfast cereal, and other foods?

These tragedies have common factors. All involve products regulated by FDA. All involve products that have killed or injured American consumers: more than 80 dead from Heparin, with hundreds more injured. Three killed by spinach last summer, and dozens sickened. All involve contaminated products, and failure by their manufacturers or growers to prevent them.

There are some important differences, however. Heparin involves one of the most highly regulated types of product—a prescription drug. FDA approved it before it could be marketed, and its manufacture is highly regulated, including a requirement to seek approval of changes to the process. Still, it illustrates gross inadequacy in this regulatory scheme. Its manufacturer didn't carefully scrutinize how it obtained the active ingredient, which is derived from pig intestines, in this case in China. FDA regulations apparently didn't require it to do so, and FDA never examined these sources itself.

The standard test for Heparin was unable to detect the contaminant. As a result, a tainted ingredient was brought into the United States and made into a deadly drug. The manufacturing process in high-tech plants ultimately proved meaningless to defeat the problem of raw materials shipped from grossly inadequate suppliers. Even the most up-to-date manufacturing processes won't ensure safety if manufacturers can't guarantee the ingredients aren't contaminated.

The Heparin contaminant is not naturally occurring. It may have been added intentionally, perhaps because of economic fraud.

It's unclear how FDA could have prevented this tragedy, given its current authorities and resources. An inspection of the Chinese supplier of the Heparin might have detected the intentional adulteration, if there had been open evidence of the crime in the plant. Because criminals tend to hide their activities, finding open evidence seems unlikely.

Practical solutions are available. Drug companies should be required to know more about the firms from which they obtain their ingredients, and audit them for ongoing compliance. Many reputable drug companies do so already.

Manufacturers must also use better tests of their own to detect impurities and contaminants. FDA obviously needs greater authority and significant additional resources to enforce these requirements, especially with respect to ingredients manufactured overseas. The mushrooming problem is clearly overwhelming the agency's current oversight.

By most accounts, the recent contaminants in food have not been intentional, but the solution is similar. Companies must be held accountable for preventing food-borne hazards. Many of the best companies already analyze hazards in food and adopt controls to avoid them. Preventive controls should be a standard requirement for every firm in the food industry, and FDA needs greater authorities and greater resources to oversee these responsibilities. Better surveillance to detect food-borne illnesses and their causes will enable both FDA and the industry to respond more effectively when an outbreak occurs, and to focus on areas that have the most public health benefit.

It's the responsibility of manufacturers to build quality and safety into their products. They can use processes to ensure the quality and purity of ingredients, and FDA inspection can ensure that these processes are carefully and consistently implemented.

The immediate problem is FDA's lack of resources. As GAO reported yesterday, FDA inspects domestic drug establishments at close to the required rate of once every 2 years. But there is no similar requirement for inspecting foreign drug facilities, and the agency's performance reflects this disparity.

GAO estimates it will take FDA at least 13 years to inspect every foreign drug facility. Last year, it inspected only 30 of the more than 3,200 foreign drug plants, less than one out of every hundred. The agency's plan for the current fiscal year is to inspect 50 plants. GAO says it would cost 67 to 71 million dollars a year to inspect every foreign drug facility every other year, which is the rate required in the U.S.

The agency's ability to inspect foreign food facilities is even worse. By one estimate, at the current rate, FDA will need 1,900 years to inspect every foreign food facility. These findings are very similar t the findings in the report of the FDA Science Board, which was a scathing indictment of the agency—scientifically, financially, and organizationally.

So we all have our work cut out for us. Fortunately, we have a distinguished group of witnesses today, and I thank them for joining us. I'm particularly grateful that Janet Woodcock of the FDA has agreed on short notice to discuss the Heparin situation. Thank you all, and I look forward to your insights and recommendations.

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