Lawmaker Wants Change in FDA Mission

WASHINGTON -- The FDA's current mission statement focuses on safety, efficacy, and public health, but some think the agency's goals also should include promoting economic growth and spurring jobs -- specifically in the drug and device industries.
Congress is considering massive legislation that would reauthorize user fee programs for makers of medical devices and drugs and extend those programs to makers of biosimilars and generic drugs.
The House version of that legislation contains a provision that would change the mission statement of the FDA.
The current one says that the agency is responsible for "protecting the public health by assuring the safety, efficacy and security" of human and animal drugs, biologics, devices, foods, and cosmetics.
It also says that the agency is responsible "for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable."
The proposed revision -- written by Rep. Mike Rogers (R-Mich.) -- says that the FDA "protects the public health and enables patients to access novel products while promoting economic growth, innovation, competitiveness, and job creation among the industries regulated by this Act."
The FDA has been the subject of much criticism from industry -- especially the medical device industry -- over an approval process that the industry charges is riddled with excessive wait-times and a lack of consistency in FDA approval decisions. The hostile approval climate has led many companies to seek approval overseas instead of in the U.S., which has also led to a loss of U.S. jobs, according to device makers.
The issue of changing the mission statement of the agency to focus on job creation and economic growth was first brought up several weeks ago during a congressional hearing and emerged again Wednesday during a House Energy and Commerce Health Subcommittee hearing on user fees.

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