AAM To OMB: Quality Metrics Guide Violates Laws, Against Program's Purpose

The Association for Accessible Medicines is calling on both FDA and the White House to pull FDA's November 2016 draft guidance on quality metric submissions, arguing the guide runs counter to a slew of federal laws and agency regulations. In addition to its legal arguments, the generic drug trade group says the guidance is contrary to the program's stated goals, and could lead to drug shortages, inefficient inspections and higher drug costs. The group says the guidance runs against the...