FDA proposed rule to change label requirements would cause dangerous confusion, raise costs

The Food and Drug Administration’s Proposed Rule to change prescription drug label requirements risks the safety of millions of patients, according to the expert panel, Labeling: Patient Safety and Politics, convened at the US Generic Pharmaceutical Association (GPhA) annual meeting in Orlando.

“The first priority of GPhA and its member companies is patient safety,” said Ralph Neas, president and chief executive of the GPhA, adding: “The Proposed Rule can be improved. For instance, the current draft allows for multiple different labels for medicines that chemically are the same. This would cause dangerous confusion and have harmful consequences for patients, prescribers, pharmacists and others throughout the health system.”

Will create the chaos FDA has sought to avoid