FDA’s Approach to Drug Patent Listing Blasted After FTC Move (1)

The head of the US Food and Drug Administration put the onus on drugmakers to ensure Orange Book listings meet legal and regulatory standards as the US Federal Trade Commission announced Tuesday it’s challenging 110 patent listings in the FDA’s registry of approved drugs.

Some experts think the FDA should play a bigger role in policing companies’ submissions. The founder of one nonprofit public-health advocacy group said the FTC’s move is embarrassing for the FDA.

“Something needs to change, because you can’t have a system where patents are part of the regulatory mechanism and yet the regulatory agency doesn’t know ...