The FDA Just Lost a Lawsuit That Could Change How Drugs Are Regulated

A small drug company has won an early fight in its case against the FDA, which will allow it to promote its fish-oil pill for treatments not explicitly approved by the agency. The federal case has huge implications for the future of prescription drugs in the US and could weaken the FDA’s power to regulate how drugs are marketed.

Source: The FDA Just Lost a Lawsuit That Could Change How Drugs Are Regulated

The ruling has nothing to do with consumer focused advertising. It has to do with informing and promoting off label uses of the drug to doctors. Pharmaceutical companies are free to share any research with doctors that support uses of the drug not specifically approved by the FDA.

Also, the ruling is incredibly specific to Amarin and outlines exactly what is a truthful and non-misleading in the context of Vascepa only. So in response to the article headline, yes this could change how the FDA regulates drugs but in reality it hasn’t and won’t.