Editorial: Drug, Device Reform Gets Bipartisan Push

Publication: The Minneapolis Star Tribune

07/02/2012 - The U.S. Supreme Court's eagerly awaited Affordable Care Act ruling unfortunately overshadowed the unusually bipartisan work underway at the U.S. Capitol last week, where Congress finalized sweeping legislation crammed with smaller-scale but still vital health reforms.

Among other things, the FDA Safety and Innovation Act will streamline medical-device approvals, help prevent shortages of lifesaving drugs and guard against dangerous new synthetic drugs -- measures championed by Sen. Amy Klobuchar and other members of Minnesota's congressional delegation.

Although a groundbreaking reform -- a new "track and trace" system to guard against the growing problem of counterfeit drugs -- was dropped from the final legislation, President Obama should move quickly to sign it.


The bill's main mission: determining how much in user fees the industries will pay the FDA in the next five years to offset the cost of clearing new products for market. The industries will contribute about $6 billion through 2017. The funding is longstanding practice and is supposed to help the resource-strapped agency review new products in a timely fashion.


Read the full editorial, Drug, Device Reform Gets Bipartisan Push, on the StarTribune's website.

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