Lawsuit Challenges Laws Regulating Off-Label Prescription Practices

Off-Label Prescriptions

Federal law requires all medications sold in the United States to undergo rigorous testing to determine what conditions the drug is capable of treating and what side effects the drug causes. The law also states a medication can only be prescribed to treat conditions the U.S. Food and Drug Administration (FDA) has given the drug approval to treat. Yet each year, thousands of patients are harmed as the result of doctors prescribing drugs to treat conditions for which they haven’t been approved—a practice known as “off-label” prescribing.

Challenging Off-Label Prescription Laws

Laws regulating off-label prescriptions are in place to protect the public from harm. However, our Terre Haute personal injury lawyers at Fleschner, Stark, Tanoos & Newlin point out that a company that manufactures a medication that lowers triglyceride levels in the blood is challenging these rules. Representatives of the Amarin Corp. are arguing their rights to free speech are violated by these rules.

The company claims that its drug, Vascepa^®, can reduce a patient’s chance of heart attack and other cardiovascular health issues when taken with cholesterol-lowering statins. Reports from Yahoo News indicate the FDA says the company cannot make the claim without further testing and safety studies.

A lawsuit has been filed to settle the matter and the ruling could alter the regulations that oversee off-label prescriptions.

Hoping for Clarification

At Fleschner, Stark, Tanoos & Newlin, our legal staff is aware of how complicated the laws regulating prescription drugs can be. That’s why our drug injury lawyers are hopeful a decision in the lawsuit will keep the best interests of patients in mind, and will result in clarification regarding how medications can be marketed.