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.
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.
Obesity has reached epic proportions in the United States and is rising in other developed and developing countries as they adopt our diet and lifestyle. Autoimmune diseases, like celiac disease and multiple sclerosis, and allergies, also immune-mediated, have blossomed recently, too.
These conditions have exploded within too short of a time period to be attributable to genetic changes, so environmental factors, from synthetic pesticides to plastics to antibiotics, have been blamed for their increased prevalence. While it’s probably simplistic to search for one cause to explain away both these types of modern ills, some studies are indicating that immune cells and molecules are important for regulating metabolism—and are dysregulated in obesity.
A new regulation is set to take effect in California at the beginning of next year that will force hen houses to allocate significantly more room to each egg-laying chicken.
Birds, long afforded a minimum of only 67 square inches a piece, will now need roughly 116 square inches—a more than 70 percent increase—if eggs are to be sold in the state. That extra space won’t come free of charge, a cost that will almost certainly fall on consumers.
Egg prices could jump by as much as 20 percent in California as a result of the the new rules, Dermot J. Hayes, an agribusiness professor at Iowa State University in Ames, told Bloomberg.
It will be interesting to see if history repeats itself, given the result of similar regulations in Europe. Speaking from local perspective, farms don’t make money. To put it another way – do you know any wealthy farmers? They’re as rare as hen’s teeth 😉