Drug makers and the Food and Drug Administration (FDA) have often disagreed over whether drug makers can discuss unapproved uses for their products with physicians. While courts have sided with drug makers in certain situations, the federal government (including the FDA, HHS-OIG, and DOJ) still holds policies and positions that disapprove of the practice. In fact, the FDA has taken severe regulatory action, including prosecution and the issuing of fines, against drug companies for speaking with physicians about “off label” uses for medications.
On May 7, 2015, drug maker Amarin Pharma (Amarin) sued the FDA. Amarin is arguing that it has a constitutional right to share information, including off-label information, about its products with physicians and other prescribers. Interestingly, unlike in previous actions in this area by other drug companies, Amarin is preemptively suing the FDA without having been accused of wrongdoing.
In this action, the drug at issue is Amarin’s only product, Vascepa. The FDA has approved Vascepa for use in patients with extremely high levels of triglycerides. Amarin was denied FDA approval to expand the drug’s reach to a larger population. Amarin contends that it was not trying to market the drug to a wider population. Rather, the company says that it wants to share the results of a company-sponsored clinical trial that showed Vascepa was effective in patients with “persistently high” triglyceride levels. Critics of the Amarin suit claim that Amarin is attempting to circumvent the authority of the FDA, which is responsible for ensuring the safety and efficacy of drugs.
It will be interesting to see how the FDA responds to industry pressure and whether the FDA clarifies its position on sharing information with prescribers. Andrea Fischer, a spokesperson for the FDA, said the agency is planning to issue more comprehensive guidance to the industry on what types of information can be shared, although no date for the forthcoming guidance has been specified. The FDA has also expressed its intention to hold a public meeting on the issue. The Amarin case and the FDA’s forthcoming guidance could have far-reaching implications for the off-label promotion of drugs, and stakeholders should continue to monitor this area closely.