Amgen To Pay $71M To Settle Improper Rx Marketing Allegations
On Tuesday, Amgen announced that it has reached a $71 million settlement with 48 states and Washington, D.C., over allegations that the company improperly marketed two of its blockbuster drugs, the Wall Street Journal reports (Stynes, Wall Street Journal, 8/18).
In 2012, Amgen pleaded guilty to improperly marketing its popular anemia drug Aranesp and agreed to pay $762 million in criminal penalties and civil settlements. Federal prosecutors at the time called the settlement "the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history" (Pfeifer, Los Angeles Times, 8/18).
In a statement, Amgen said the new settlement resolves some states' issues related the 2012 federal lawsuit over the marketing of Aranesp and Enbrel (Wall Street Journal, 8/18).
The states alleged that Amgen:
- Endorsed Aranesp for anemia caused by cancer without FDA approval or scientific evidence;
- Endorsed Aranesp for dosing frequencies longer than those approved by FDA;
- Endorsed Enbrel for mild plaque psoriasis when it is only approved by FDA for chronic moderate to severe forms of the condition; and
- Exaggerated the length of Enbrel's efficacy.
Under the settlement, Amgen did not admit to any wrongdoing. However, Amgen is not allowed to:
- Claim the drugs have any qualities or benefits they do not actually possess;
- Make deceptive, false or misleading claims about the drugs; or
- Promote off-label use of the drugs to providers (Schencker, Modern Healthcare, 8/18).
The company also has adopted a new corporate integrity policy as part of its deal with the federal government (Los Angeles Times, 8/18).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.