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Public Statements

Energy and Commerce Committee Unanimously Approves FDA Legislation

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This morning, the House Energy and Commerce Committee unanimously approved the Food and Drug Administration Reform Act of 2012, legislation to reauthorize and reform user fee programs. Congressman Joe Pitts (PA-16), as Chairman of the Health Subcommittee, took a leading role in crafting the bipartisan compromise.

"I'm very proud of the work we've done to reach a bipartisan agreement on a bill critical to medical research in the U.S.," said CongressThis morning, the House Energy and Commerce Committee unanimously approved the Food and Drug Administration Reform Act of 2012, legislation to reauthorize and reform user fee programs. Congressman Joe Pitts (PA-16), as Chairman of the Health Subcommittee, took a leading role in crafting the bipartisan compromise.

"I'm very proud of the work we've done to reach a bipartisan agreement on a bill critical to medical research in the U.S.," said Congressman Pitts.

The FDA is responsible for reviewing new applications for drugs and medical devices. In order to provide the FDA with enough resources to conduct reviews in a timely manner, industry agrees to pay user fees. The legislation that governs this process needs to be renewed every five years.

"The United States is the world leader in development of new devices and drugs," said Congressman Pitts. "In order to maintain this edge we need FDA reviews to be transparent and predictable. In recent years, investment has been moving to Europe where the review process is safe but less cumbersome. With this bill, we can restore balance and keep jobs in America."

The FDA Reform Act also contains provisions to combat critical drug shortages. In recent years, hospitals have faced shortages of injectable medicines, including drugs that treat cancer.

The Senate Committee on Health, Education, Labor and Pensions has approved similar legislation along bipartisan lines. Following House passage of the bill, Congressman Pitts will work with his Senate counterparts to reach an agreement on the final bill. The bill is on track to be sent to the President this summer.man Pitts.

The FDA is responsible for reviewing new applications for drugs and medical devices. In order to provide the FDA with enough resources to conduct reviews in a timely manner, industry agrees to pay user fees. The legislation that governs this process needs to be renewed every five years.

"The United States is the world leader in development of new devices and drugs," said Congressman Pitts. "In order to maintain this edge we need FDA reviews to be transparent and predictable. In recent years, investment has been moving to Europe where the review process is safe but less cumbersome. With this bill, we can restore balance and keep jobs in America."

The FDA Reform Act also contains provisions to combat critical drug shortages. In recent years, hospitals have faced shortages of injectable medicines, including drugs that treat cancer.

The Senate Committee on Health, Education, Labor and Pensions has approved similar legislation along bipartisan lines. Following House passage of the bill, Congressman Pitts will work with his Senate counterparts to reach an agreement on the final bill. The bill is on track to be sent to the President this summer.


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