Kay Hagan Backs Legislation for Management Review Board at FDA

Sweeping new legislation drafted by Senator Kay Hagan (D-NC) in collaboration with the Biotechnology Industry Organization would establish a powerful internal management review board at FDA. The board would be charged with reporting to the HHS secretary on determining “optimal allocation of responsibilities and to improve the efficiency and effectiveness of each office, center, and division in achieving individual and overall missions” of FDA, according to a draft of the legislation.

Hagan’s bill, called “Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT),” would authorize the board to reach out to internal and external entities, including venture capital firms and patient representa-tives. Up to nine of its 22 members would be appointed from within FDA and the remainder would be chosen from outside HHS based on expertise, including at least one each from the medical device, food, drug, and biotech industries. TREAT would require the appointment of a chief innovation officer within the office of the commissioner to, among other things, identify and integrate into the review process “promising new scientific and regulatory approaches to ensure the rapid development, testing, and review of new drugs and devices,” according to the draft.

CDRH and FDA’s drugs and biologics centers would each be required to accept the placement of chief medical policy officers appointed by the HHS secretary to work with the chief innovation officer and the center directors in implement-ing the bill’s objectives.

TREAT would also establish a fixed six-year term for the FDA commissioner, but permit unlimited reappointments.
Former FDA deputy commissioner Peter Pitts writes on his blog, drugwonks.com, that under the bill, “drugs would be eligible for ‘progressive’ or ‘exceptional’ approval if they provide meaningful advances in treating an unmet serious or life-threatening condition.” The agency, he writes, “could also approve drugs based on approval in the EU as well as in Australia, Canada, or some other countries.”