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Compliance In Focus
Posted by John Lehmann on Mon, Dec 1, 2014

FDA Reforms Looming?

An article in “The Gray Sheet” recently caught my attention.  It talked about how the recent FDA Reforms Loomingtakeover by the Republican Party in the Senate, along with an increase in GOP House seats, could lead to an increased oversight of the FDA.

John Manthei, a partner with Latham & Watkins feels that the resulting changes mean “We may see the broadest scopes of FDA reforms, in a non-user fee reauthorization year, than we’ve seen in memory.”  He predicts the FDA will be in the crosshairs of the new Congress which will be taking a hard look at how the FDA will be using its resources and oversight initiatives.

A key player will be House Energy and Commerce Committee Chair Fred Upton.  Upton along with Representative Diana DeGette (D–CO)—have pursued a project they’ve dubbed the 21st Century Cures Initiative. The goal: to speed up the lengthy and costly process of developing new treatments for disease.  He views this initiative as a legacy piece. Upton promised in the most recent 21st Century Cures hearings that the committee will release a discussion draft on a long list of FDA reforms by early next year.  His goal is to have a bill finalized in 2015.

One key promise that Upton made to FDA Commissioner Margaret Hamburg during a 21st Century Cures hearing was to eliminate the provision that a local IRB has to approve every trial that a medical device goes through, even multi-site, multi-jurisdictional trials.

In the Senate, the new majority leader Mitch McConnell will have to find ways to work with Democrats to move legislation forward.  In the past, he has been successful in keeping his members together.  Steven Grossman, deputy director for Alliance for a Stronger FDA, believes that top priority is resolving the nation’s budget impasse.  “Until the parties can agree on entitlements and taxes, Congress is by default, going to concentrate on cutting discretionary spending.”  This would include FDAs spending. 

With a new Congress in 2015, what are your thoughts on the impact to the FDA?  Please share your thoughts below.

Photo Credit: John

Risk Management in Clinical Research | Free Download | IMARC Research

Topics: John Manthei, Fred Upton, 21st Century Cures, Margaret Hamburg, FDA

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