The search for new TB drugs and diagnostics is a long and windy road, paved with regulatory bumps and expensive R & D hurdles.
But the path could get a little smoother under an amendment recently added to the Senate’s fiscal year 2010 funding bill for the Food and Drug Administration and other related programs. The provision, offered by Sen. Sam Brownback, R-Kansas, would require the FDA commissioner to create two review groups to recommend new solutions for “the prevention, diagnosis and treatment of rare diseases and neglected diseases in the developing world.”
Brownback’s provision aims to streamline the regulatory process for new drugs and other tools to combat rare and neglected diseases that can take a huge toll on poor people in the developing world, where the potential to make big bucks off a new drug are slim to none. Click here for the amendment text and status of the bill.
In his floor speech urging support for the provision, Brownback specifically mentioned tuberculosis as a neglected disease that is “rampant” in the developing world but that has not gotten adequate R & D attention.
“You can have millions, even more than that, who are affected by a disease, but there is not a large marketplace to support the research that is necessary to develop a cure,” Brownback said. “It is my hope that what this will lead to is us developing systems and ways where we can reduce the cost and the time for drug delivery and development.”
Brownback’s provision passed the Senate but is not included in the House version of the bill. So a House-Senate conference committee will decide its fate. The Center for Global Health Policy, along with a coalition of other groups, is strongly supporting final passage.