Amarin’s Lawsuit Could Have Huge Benefits For Pharma Industry And Dire Consequences For Consumers
Pharma companies have long demonstrated that they will employ questionable marketing and sales tactics to boost sales, no matter what the impact is on patients’ health.
Now Amarin, a small drug maker that sells the prescription drug Vascepa, hopes to bolster its bottom line by suing the Food and Drug Administration, claiming that the company’s First Amendment right of free speech has been trampled by the government.
It costs Amarin relatively little to launch this lawsuit, which was filed in federal court in New York earlier this month, but the consequences to Americans could be huge.
Amarin’s one product, Vascepa, is FDA-approved only to treat individuals with extremely high levels of triglycerides (above 500 mg/dl), a fat that is linked to heart disease.
Several years ago, Amarin tried to expand the population of patients who could be treated on-label with Vascepa, and asked the FDA to approve treatment for people with lower levels of triglycerides and who had cardiovascular disease or who were at risk of it.
The FDA denied Amarin’s request because, as the company reported in SEC filings in 2013, several clinical trials “fail[ed] to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular events” in individuals with lower triglyceride levels (below 500 mg/dl).
Despite the fact that the FDA’s denial is based on science, Amarin claims that the First Amendment should allow it to include on Vascepa’s label, data showing that the drug lowers triglyceride levels – even though, as Amarin previously noted in its SEC filing, clinical studies do not support a meaningful reduction in cardiovascular risk.
Amarin’s lawsuit is just the latest skirmish in Big Pharma’s offensive against prescription drug-marketing regulations.
In recent years, Allergan and Par Pharmaceuticals have urged courts to shield them from FDA marketing restrictions on so-called free-speech grounds. Both Allergan and Par Pharmaceuticals ultimately dropped their First Amendment challenges and pleaded guilty to criminal and civil violations of FDA misbranding laws. (Allergan, acquired by Actavis in March, is now back in court, fighting a separate whistleblower lawsuit that alleges kickbacks to doctors.)
This time, Amarin’s overly aggressive First Amendment arguments are aimed at diluting drug approval processes and target marketing restrictions that protect patients from unproven, unscientific, misleading and distorted marketing of prescription drugs.
In actuality, this isn’t a free speech issue. It’s an effort by Amarin to circumvent the FDA approval process and confuse patients and doctors about the benefits of its prescription drug by publishing the very data that the FDA found did not support treatment for particular conditions.
Indeed, a confidential letter Amarin sent to its physician speakers about the lawsuit is revealing in what it omits. The letter describes the drug’s success in lowering triglycerides, but it does not say (as it reported in 2013 SEC filings) that the FDA “no longer considers a change in serum triglyceride levels as sufficient to establish the effectiveness of a drug intended to reduce cardiovascular risk in subjects’ serum triglyceride levels below 500 mg/dl.”
The letter also reports that Amarin’s Vascepa clinical trial was conducted under a special protocol assessment agreement (“SPA”) with the FDA, but it does not say that the FDA rescinded the SPA underlying the clinical trial because it “determined that a substantial scientific issue essential to determining the effectiveness of Vascepa in the studied population was identified after the testing began.”
Based on this case, it seems Amarin’s ultimate marketing strategy for Vascepa is to bank on patient confusion about the drug’s benefits to increase sales, rather than proven clinical benefits. The court should recognize Amarin’s lawsuit for the sham that it is and allow the FDA to do its job and continue to protect patients.
Source: Forbes
