Drug company sues over ban on marketing a drug for rejected use

In a lawsuit filed today against the Food and Drug Administration, the drug manufacturer Amarin Pharma claims that the FDA's bar on drug companies marketing their products for uses that have not been approved by the FDA violates the company's right to free speech. In this case, not only is the use unapproved, but the FDA has specifically rejected the use because the company failed to show that it had any health benefit.

A New York Times article has details.

Read the complaint here.

Drug companies have for years pushed against the federal prohibition against promoting their products for unapproved uses. The companies say that they want to give information about additional potential benefits to physicians. And of course, marketing for additional uses may lead to a big boost in profits.

The Food, Drug, and Cosmetic Act, however, allows companies to market their drugs only for FDA-approved uses. FDA approval ensures than an objective expert agrees with the company's claims that the product is safe and effective for the stated use(s). In this way, patients are protected from buying snake-oil in the guise of medication. If a drug company could use FDA approval for one use as license to push its drug for different unapproved uses, the company would have no motivation to seek FDA approval for those other uses. As a consequence, we would never have an objective evaluation of the products' safety and effectiveness for those other uses.

Allowing companies to market drugs for unapproved uses is no more required by the First Amendment than allowing companies to sell snake oil.

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