After a new ruling by a court of the U.S., the FDA loses the case against drug marketing. The case was directed at a fish-oil pill manufacturer which, according to the FDA, used false labeling of the pill in an effort to promote its product.
The marketing of the drug essentially used false info and pseudo-science made up from shady research to promote the pill not only to patients, but also to doctors so that they in turn make their patients buy the drug. The label spoke about an unapproved usage, the beneficial results of which have never actually been proven.
However, Amarin, the company behind the fish-oil drug called Vascepa, said that the restrictions posed by the FDA are abusive and go against the First Amendment.
The Vascpa drug is mainly used to lower a specific type of fat – high levels of triglycerides. Amarin however wanted to sell the drug as being usable by people with lower triglycerides, but who were under the use of cholesterol lowering meds, known as statins.
The FDA requested of the company to provide more research leading to the conclusion that the drugs actually help in reducing heart problems in the latter patients. If they did not, the restrictions would hold. However, Amarin went behind the FDA’s back and filed a lawsuit against them.
The problem is not necessarily with the way the product is advertised, as the FDA has clearly stated that false advertising is banned, but with the data about the drugs, which often is presented in materials by the drug’s manufacturer. This data is often made up of medical journal articles which turn out to be fake.
Still, the Dublin based Amarin Corporation PLC, has said that so severely regulating what information is conveyed along with their product effectively denies the company the right to free speech. The judge that ruled over the case, Paul Engelmayer of the U.S. District Court, made a preliminary ruling, accompanied by 71 pages stating his opinion on the mater.
The ruling was in favor of Amarin. The FDA may not regulate the company if the off-label use of the fish-oil pill Vascepa is truthful and non-misleading.
The FDA has responded to this ruling by saying that it has already allowed Amarin to market the drug that way, and that the fact that the company is now boasting with the results of the suit may be just a marketing move.
Still, many voices are saying that the FDA is beginning to lose its grip on drug advertising.
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