A question from Shelia Ward of Derry, NH:
I read that the FDA's budget is slated to increase quite a bit over the next year. Can this agency expand its budget and its responsibilities without becoming wasteful and inefficient?
Rep. Carson responds:
Waste and inefficiency are always legitimate concerns when proposals are made to increase an agency's budget and it is the responsibility of Congress to exercise strict oversight of agency activities to ensure against such abuses. As an agency's budget grows that responsibility becomes even greater. If reforms are made to speed up the FDA process of drug approval and to regulate food safety more stringently, Congress must be diligent in making sure waste and inefficiency do not occur.
Rep. Sununu responds:
The FDA budget for fiscal year 1998 is anticipated to increase by approximately 4% over 1997 levels, to roughly $1.0 billion. Since 1985, the FDA budget has increased over 80% in constant dollars.
During this period, as demands on the FDA have grown, the FDA's bureaucracy has become more expansive and less responsive. Last week, however, the House Commerce Committee began
consideration of FDA reform legislation. These three bills address a number of issues including:
a. Creating a streamlined process for approving new drugs, especially those that address life-threatening diseases.
b. Implementing special clinical trials to ensure safer drugs for children.
c. Allowing for the independent review of the least complex medical devices and simpler procedures for demonstrating effectiveness during clinical trials.
d. Encouraging faster action by the FDA regarding health and nutrition claims for foods.
These measures will help ensure the safe, timely, and cost effective delivery of new and valuable products to those in need.
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