Sens. express support for FDA's limited-use pathway

Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah) sent a letter to FDA Commissioner Margaret Hamburg voicing support for the agency's proposed limited-use drug approval pathway for serious or life-threatening conditions, including infections caused by antibiotic-resistant bacteria. The Senators proposed initially testing the pathway with antibiotics to "encourage investment in new antibiotic research where development paths are currently viewed as too long and uncertain to attract capital." Bennet and Hatch said the program should then "evolve based on current need" to other disease areas, but should remain voluntary for drug sponsors and should ensure that neither FDA nor sponsors "are put in the inappropriate position of policing the judgments of medical professionals in treating their patients." The Senators added that they "welcome a conversation" about the legislative authorities necessary for FDA to "make the pathway a success." ...