FDA Reform Bill Would Give Commissioner Fixed Term, Add Review Board
This article was originally published in The Tan Sheet
Executive Summary
The Transforming the Regulatory Environment to Accelerate Access to Treatments Act would mandate a fixed six-year term for the FDA commissioner and the agency’s centers would receive a chief medical policy officer, according to a draft of the bill.
FDA could see several structural changes to speed product review pathways under legislation being developed by Sen. Kay Hagan.
The North Carolina Democrat’s Transforming the Regulatory Environment to Accelerate Access to Treatments Act also would mandate a fixed six-year term for the FDA commissioner, according to a draft of the bill.
Removal of the commissioner would be allowed for cause and reappointments would be unlimited, according to the draft bill.
The idea has been bandied about for several years to allow for more stable leadership at the agency.
The Biotechnology Industry Organization included it in its “Big Ideas” proposal for FDA reforms this year, and in 2007 an Institute of Medicine special task force called for it .
A new management review board also would advise FDA about organizational issues, including reviewing center and division responsibilities to ensure they run efficiently and not overburdened.
The TREAT Act would create an Office of the Chief Innovation Officer within the Office of the Commissioner. The innovation office would “identify promising new scientific and regulatory approaches to ensure the rapid development, testing and review of new drugs and devices,” according to the draft bill.
Examples of specific tasks for the position included biomarker qualification and validation, predictive toxicology and adoption of new clinical trial designs and methods.
The innovation office also would coordinate and optimize efficient review processes for drugs, devices and companion diagnostics. That could include helping implement new progressive and exceptional approval pathways, which the bill includes.
The new pathways likely would codify existing FDA practices of approving drugs in certain cases without a traditional evidence package.
Centers Would Receive New Policy Officers
The Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health also would receive a chief medical policy officer that would help create “proactive and consistent approaches” for application review divisions to address “emerging medical and scientific policy issues,” according to the draft bill.
CDER currently organizes medical policy efforts in a recently elevated office headed by Rachel Sherman. Robert Temple serves as the center’s deputy center director for clinical science (Also see "FDA's Office of Medical Policy Grows Into A "Super Office"; DDMAC Gets A Promotion" - Pink Sheet, 19 Sep, 2011.).
The draft bill’s mention of consistency in drug reviews is significant because the perceived lack of it has been a complaint of industry and is seen as contributing to a lack of investment in the sector.
The officers also would promote “earlier and improved utilization of advisory committees” in the review process, including the “investigational testing phase” and improve reviewer access to external experts, according to the legislation.
The bill would loosen the conflict of interest restrictions for participation in advisory committees.
The pending agreement with industry to reauthorize the Prescription Drug User Fee Act includes a new application review model for new drug applications for new molecular entities and novel biologics license applications that would allow for more sponsor interaction with reviewers earlier in the process.
The TREAT Act could be among several issues Congress addresses in the PDUFA reauthorizing legislation (Also see "What’s In A PDUFA Reauthorization? Maybe These Issues…" - Pink Sheet, 11 Jul, 2011.).
Hagan, a member of the Senate Health, Education, Labor and Pensions Committee, is among the senators working closely on the PDUFA legislation. Her state includes the Research Triangle, a large research hub in the Raleigh-Durham area that includes biotech facilities.
She expressed interest in making communications between sponsors and FDA more transparent during a July HELP Committee hearing on user fee bills where Commissioner Margaret Hamburg was questioned.
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