FDA to expand generic drugs’ labeling powers

{mosads}That rule should help drug companies notify consumers about possible risks and dangers in drugs, proponents hope.

In a statement after the regulatory agenda was published, Sen. Patrick Leahy (D-Vt.), the head of the Senate Judiciary Committee, said that the rule should fix a “troubling inconsistency in the law.”

He added, “Responsible brand-name and generic manufacturers alike should have the ability, and the obligation, to give doctors and patients the information they need to avoid injuries.” 

Currently, generics either need the FDA to order a label change or the brand name manufacturer to do it first.

That law has led the Supreme Court to side with generic drug companies in lawsuits brought by injured consumers.

Last month, the Supreme Court ruled in a 5-4 decision that injured patients cannot sue manufacturers of generic drugs to pull the product off the market. The decision follows a 2011 ruling that generic drug companies cannot be sued for poor labeling, since generic drugs must conform their labels to the brand name pharmaceuticals.

That same day the recent decision was announced, the nonprofit consumer organization Public Citizen published a study showing that the current rules are not adequate to prevent the public from dangers. 

The group found at least 434 generic drugs that no longer have a brand name equivalent, and noted that drugs’ risks could take years or decades to emerge.

The generic drug industry pledged to work with the FDA to implement any new rules.

“Our members have a long history of working closely with FDA to ensure that Americans have access to safe affordable generic medicines, and we look forward to working with FDA on this important issue,” said Ralph Neas, president and chief executive of the Generic Pharmaceutical Association, in a statement.