May 22 2012
Today, Senator Tom Coburn, M.D. (R-OK) filed the following two amendments to S. 3187, the FDA User Fee Reauthorization bill, being considered in the Senate this week.
Coburn Amendment - To Require FDA Employee Performance Standards Hold Reviewers Held Accountable for Their Contribution Toward Meeting User Fee Agreement Goals
This amendment requires FDA employee performance standards to hold reviewers held accountable for their contribution toward meeting user fee agreement goals. GAO’s May 18, 2012 report found that during the period of GAO’s evaluation, not all FDA employees involved in the review process of medical products were required to be explicitly evaluated with regard to their role in helping the FDA meet the user fee agreement goals. Additional background here.
Coburn Amendment - To Require an Independent Assessment of the FDA’s Drug Application Review Process.
This amendment requires FDA to contract with an independent management company to conduct an assessment of all of the drug review and approval processes. The medical device user fee agreement includes the requirement for an independent assessment of FDA’s management. This is a common-sense requirement that will help inform FDA’s leadership and Congress – however, this review does not apply to the drug review process. Congress, consumers, and patients deserve an independent and objective look at FDA’s management of its mission and resources. Additional background here.
This amendment is a provision included in Senators Coburn and Burr's PATIENTS' FDA Act that was not included in the bipartisan legislation voted out of the Senate Health Education Labor & Pensions (HELP) Committee.