In the rush for greater market share and more revenue, there will be times when the line between what is right and what is wrong will be blurred. In a case of stringent monitoring by FDA and SEC, Aegerion Pharmaceuticals, a company dedicated to the development and commercialization of therapies for enfeebling rare diseases has pleaded guilty to misbranding of its key revenue driving drug, Juxtapid. Concurrently, the firm is also facing a potential US$4.1 million penalty from SEC for fraud with the same drug.
Aegerion Pharmaceuticals acknowledged violations with FDA, and getting charged by SEC for fraud
Juxtapid is one of the company’s best selling drug, and is featured prominently at the company’s information page. However, some problems have came up with the drug, which functions as a cholesterol lowering drug (through preventing or mitigating against its production in the liver). The issue of over promotion on the capabilities of Juxtapid was a key area of contention as the firm failed to make transparent clear directions for use in a bid for more market share. It was required to do that to meet the FDA’s Risk Evaluation and Mitigation Strategy (REMS).
Not touching on the exact use cases for Juxtapid to gain more market share and patients using the drug
According to the filing, instead of following the REMS requirement to only distribute Juxtapid to a select patient group suffering from a particular type of rare disease which results in early cardiovascular diseases, Aegerion tried to classify the diagnosis of homozygous familial hypercholesterolemia (HoFH) which was traditionally a rare disease as ambiguously as possible to sell the drugs to additional patients who might not be suffering from HOFH. The filing also said that Aegerio “..failed to give health care providers complete and accurate information about HoFH and how to properly diagnose it.
SEC going after the company for making exaggerated claims about new patient numbers and misleading investors
Investors were told by Aegerion that the number of prescriptions which were unfilled for the drug was not material as the “vast majority of patients” who received prescriptions go on to purchase the drug. However, based on records from Aegerion, it was only 50% of prescriptions which resulted in actual drug purchases!
Juxtapid was priced in the range of about US$250,000 to $300,000 per patient 3 to 4 years back. Looking back, that was definitely a substantial amount of money or revenue which was over-reported by Aegerion. Juxtapid was approved by the FDA in December 2012.
A capitalistic approach to monetizing the drug might have created unknown casualties
One thing which really stood out for me while reading through the article was the fact that the firm deliberately concealed information about diagnosis and relevance of the drugs to doctors and hospitals. The patients who mistakenly purchased the drugs based off the prescriptions might have experienced certain side effects but went unreported.
The healthcare industry is a trillion dollar industry, and the opportunities for quick profits exist. However, given the sanctity of the mission of the industry, should we not be more stringent towards violations?