Friday, June 5, 2015

FDA labels

In what may be a groundbreaking event, the constitutionality of FDA labels is brought into question, not by what is in the label, but what is left out.

Ethical, Legal & Social Issues
 Discussing off-label uses of drugs with doctors: a constitutional right or sidestepping the United States FDA authority?
 A Dublin based pharmaceutical company - Amarin Pharma, is currently in the process of suing the Food and Drug Administration of the United States for the right to talk about unapproved uses for their products as long as it is an honest depiction of the products capabilities. Even though some lower courts have agreed to this practice, the federal government in the United States have levied huge fines to some companies for talking to patients about off-label use for their medications. AmarinPharma is arguing that it has a right under the First Amendment (free speech) of the constitution of the United States to share certain information about its product with doctors. According to the lawyers for the company this is the first time a manufacturer had pre-emptively sued the agency over the free speech issue, before being accused of any wrongdoing. According to them “If you tell the truth — if you’re not misleading — then the First Amendment protects you when you provide this sort of information,”. But critics point out that this practice sidesteps the authority of the FDA, which is responsible for making sure that only safe and effective drugs reach the marketplace and that the constitution does not guarantee the First Amendment as an absolute right.
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