FDA Calls Amgen on Off-Label Promo Effort; the Drug Maker Paid One of Biggest Whistleblower Settlements Ever for Bio-Tech over Off-Label Claims, Says Parker Waichman LLP
New York, New York (PRWEB) November 26, 2013 -- Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, is noting that on Nov. 19, the U.S. Food and Drug Administration (FDA) issued a letter to Amgen Inc. in which it told the drug maker that a direct mailer for the company’s anemia drug Aranesp (generic: darbepoetin alfa) is “false or misleading” in that it omits important risk information linked to the drug; suggests that the drug is appropriate for a broader range of patients and health conditions than is the case; makes unsupported claims about the drug’s efficiency; and omits key details about the drug. The letter was specifically sent by the FDA’s Office of Prescription Drug Promotion (OPDP).
The direct mailer contains no references to the drug’s ability to increase the potential for deaths, heart attacks, strokes, blood clots and reduced hemoglobin levels, as well as to cause a red-blood-cell disorder, according to the letter, which adds: “The omission of this important risk information regarding multiple warnings and precautions for Aranesp misleadingly suggests that the drug is safer than has been demonstrated.” The letter further notes that Amgen also oversimplifies in several areas, which could cause readers to believe that the drug is appropriate for a broader audience than is the case. The FDA approved the drug for a narrowly defined pool of patients: those suffering from chemotherapy-induced anemia. Marketing the drug to a larger market than has been described is known as promoting “off-label” use and is not allowed by the FDA.
“Drug makers need to be extra conscientious when preparing direct mailers and other promotional material for the public,” says Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “Potential dangers in the form of adverse events should always top the list of what to include. Also companies must be mindful about not promoting their drug in an off-label fashion.”
In December 2012, Amgen paid $762 million to settle a group of whistleblower lawsuits related to the off-label marketing of Aranesp, which was described at the time as “the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history,” noted a Dec. 19 Department of Justice press release. The release further noted that the civil settlement agreement resolved claims contained in 10 lawsuits against Amgen having to do with the off-label marketing of the drug, all of which were brought under the whistleblower provisions of the False Claims Act.*
The civil settlement agreement resolves claims contained in 10 lawsuits against Amgen that were brought under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery, the press release noted.
In April of this year, Amgen agreed to pay the United States $24.9 million to settle allegations that it violated the False Claims Act by promoting the sale of two drugs, including Aranesp, for off-label use, according to an April 16, 2013, Justice Department press release.
The lawsuit – which included charges that the company prompted the off-label marketing and use of two of its drugs, including Aranesp – was filed on June 14, 2011, in the U.S. District Court for the District of South Carolina (United States ex rel. Kurnik v. Amgen Inc., et al. Case No.: 3:11-cv-01464-JFA). Among the charges noted in the Complaint were allegations that Amgen had been seeking to broaden the audience for Aranesp, thus encouraging off-label use. Specifically, “Amgen urged Omnicare, PharMerica and Kindred to expand the market for Aranesp by pressuring consultant pharmacists employed by [the aforementioned firms] to recommend Aranesp for patients for whom no physician had diagnosed anemia associated with chronic renal failure…” As the drug was approved specifically for patients suffering from anemia associated with chronic renal failure, this is alleged to have constituted off-label use of the drugs, according to court documents.
By prompting off-label use of the drugs, noted the Complaint, Amgen then caused “fraudulent [Aranesp] claims… [to be] submitted to Medicare, Medicaid and other federal healthcare programs.” The claims are alleged as fraudulent because the patients for whom the drugs were prescribed are not the type of patient approved to use the drug, as per the FDA, the Complaint added.
The False Claims Act allows private persons to file lawsuits on behalf of the government; such lawsuits are also known as “qui tam” actions. Under the False Claims Act, brought forth during the American Civil War, private individuals can bring lawsuits against companies and in return, receive protection and compensation. Amendments added to the Act in 1986 helped to incentivize these individuals – also called whistleblowers – by raising the amounts that can be charged for damages and penalties, which significantly enlarged the whistleblower’s slated portion. Whistleblowers can be awarded millions of dollars today – between 15% and 30% of the amount recovered.
In recent years many pharmaceutical employees have come forward to report fraudulent billing, illegal marketing techniques and undisclosed drug side effects. These whistleblowers have helped the federal government recover billions of dollars obtained illegally by pharmaceutical and medical device companies. Whistleblowers also save the lives of countless prescription drug and medical device users who were previously unaware of the side effects of their device or prescription.
In view of the FDA’s most recent claims, if you or someone you know has taken the anemia drug Aranesp, you may have valuable legal rights. To find out more about joining an Aranesp class action lawsuit, please visit our website or contact one of our experienced class action lawyers today at 1(800)-LAW-INFO (1-800-529-4636).
Contact:
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
1+(800) LAW-INFO
1+(800) 529-4636
http://www.yourlawyer.com
• 10 whistleblower suits: United States ex rel. Cantor v. Amgen, Inc., Civil Action No. CV-04-2511 (E.D.N.Y.), United States ex rel. Osiecki v. Amgen, Inc., Civil Action No. CV-05-5025 (E.D.N.Y.), United States ex rel. Westmoreland v. Amgen, Inc., Civil Action No. 06-CV-10972 (D. Mass.), United States ex rel. Arriazola v. Amgen, Inc., Civil Action No. CV 06-3232 (E.D.N.Y.), United States ex rel. Horwitz v. Amgen Inc., Civil Action No. C07-0248 (W.D. Wash.), United States ex rel. Kelly v. Amgen Corporation, Civil Action No. CV-08-4157 (E.D.N.Y.), United States ex rel. Hanks v. Amgen, Inc., Civil Action No. CV 08-3096 (E.D.N.Y.), United States ex rel. Ferrante v. Amgen, Inc., Civil Action No. CV-08-3931 (E.D.N.Y.), United States ex rel. Tucker v. Amgen, Inc., Civil Action No. CV-09-0887 (E.D.N.Y.), and United States ex rel. DJAE Partnership v. Amgen, Inc., Civil Action No. 11-CV- 11242 (D. Mass.).
Gary Falkowitz, Parker Waichman LLP, http://yourlawyer.com, +1 (800) 529-4636, [email protected]
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