Dear Dr. Hamburg

Gphaonline: March 14, 2014

The American health care system has a long history of underserving patients of color. While great strides have been made around improving the health of racial and ethnic minority populations through the development of health policies and programs that will help eliminate health disparities, much remains to be done. Generic medicines are a critical part of addressing the access and economic factors which often act as barriers to health care for these populations.

Patient, physician, pharmacist and payor access to generic medicines rests on the foundation of the Food and Drug Administration’s (FDA’s) approval of generic medicines as scientifically equal to the brand medicine in drug safety, efficacy and quality. Disappointingly, the FDA’s Proposed Rule on Generic Labeling, as drafted, would create substantial confusion for pharmacists, doctors, nurses, patients and others in the health care system by allowing for multiple, different drug labels in the market for the very same product, upending 30 years of law and regulation.  Read More