Pharma Times reports that drugs giant Amgen has reached a $71 million settlement with 48 U.S. states and the District of Columbia. This payment is close out a case where it is alleged that the company wrongfully promoted the biologic medications Aranesp and Enbrel, for off-label uses.
This means that the drug was marketed in such a way for a use that is not on the insert label or in relation to its product license. Each pharmaceutical drug must obtain a license from a regulatory agency. In the case of the U.S. this is the Food and Drug Administration (FDA). The product license states the dose, the target patient population and what conditions the drug can be used for. The licensing process is very strict and it is based on the submission of clinical trial data by the pharmaceutical company to the regulatory agency.
With the specific case, Amgen was named by multiple state attorney generals of violating consumer protection laws by promoting Aranesp (generic name darbepoetin alfa) at dosing frequencies longer than the FDA-approved label. In addition, the drug was apparently marketed for cancer-related anaemia, which would outwith of FDA approval.
With the second biologic drug, Enbrel (generic name etanercept), this medicine was apparently advertised to treat mild plaque psoriasis for the period 2004 to 2011. Again this was outside of the approved label for the product.
In response to the allegations, Amgen has paid out $4.6 million to California, which is where the company has its global headquarters. The state in receipt of the next highest sum is New York, with $3.16 million. The remainder of the $17 million is to be divided among other states.
Talking with news media, New York State Attorney General Eric Schneiderman, is quoted by Time Magazine as stating: “Pharmaceutical companies are prohibited from making unapproved and unsubstantiated claims about prescription drugs. Consumers need to have confidence in the accuracy of claims made by pharmaceutical companies.”
Amgen has also agreed to review its marketing practices.
