The Food and Drug Administration sometimes spends years investigating the quiet and secretive ways that pharmaceutical companies illegally promote their drugs for uses not approved by the federal agency, whose purpose is to evaluate drugs for safety or at least warn patients of dangerous side effects.
Other times, the FDA need only spend a few minutes watching video online.
The latter was true with Aegerion Pharmaceuticals, which is headquartered in Cambridge, Mass., and whose sole product, Juxtapid, was the result of work by University of Pennsylvania researchers.
The FDA approved Juxtapid on Dec. 21, 2012, to help a very small population of people with deadly levels of high cholesterol, a condition known as homozygous familial hypercholesterolemia (HoFH). But the official label says it must be accompanied by use of other medicine and a low-fat diet. Extra warnings speak of liver toxicity, among other bad side effects. Like many drugs for rare diseases, it has a high price: $295,000 per year.