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Aranesp's Serious Risks Omitted in Marketing Piece, says FDA

Aranesp's Serious Risks Omitted in Marketing Piece, says FDA

FDA Scolds Amgen Over Aranesp Claims

FDA Scolds Amgen Over Aranesp Claims

Parker Waichman LLP is investigating a class action lawsuit over misleading marketing claims made by drug maker, Amgen Inc., regarding its anemia drug, Aranesp (darbepoetin alfa). Aranesp direct mailers issued by Amgen overstated Aranesp’s benefits while also downplaying its potential ties to adverse reactions such as heart attacks and strokes, according to a just-released U.S. Food and Drug Administration (FDA) letter.

The letter is described as an “untitled” agency letter, which means that the violations discussed are, at the time the letter was sent, less serious than those that would be discussed in an FDA warning letter, according to a recent Law360 report. The federal regulator, in a four-page letter, accused Amgen of providing an incomplete picture of Aranesp’s risks.

Amgen Direct Mailer Lacking Critical Information

Although a number of Aranesp’s potential side effects are listed, the regulator indicated that there were no references regarding the drug’s potential for a number of serious adverse responses such as:

  • death
  • heart attack
  • stroke
  • blood clots
  • a specific red blood cell disorder
  • lowered hemoglobin levels

The letter indicates that, “The mission of this important risk information regarding multiple warnings and precautions for Aranesp misleadingly suggests that the drug is safer than has been demonstrated.”

The Aranesp direct mailer brochure, wrote the FDA, rather than explicitly describing these adverse events, advised readers to review a separate, included, document that included full prescribing information, and also directed readers to the Aranesp website. The agency wrote that, “These statements do not mitigate the misleading omission of important risk information from the direct mailer.”

Aranesp Benefits Over-Stated

The FDA also told Amgen that it oversimplified how the drug works in a number of areas and that these oversimplifications could cause readers to believe that Aranesp is the appropriate drug of choice for more than the tightly defined population of patients who are diagnosed with chemotherapy-induced anemia, which is for what Aranesp is approved, according to the FDA letter.

The FDA also told Amgen that it oversimplified how the drug works in a number of areas and that these oversimplifications could cause readers to believe that Aranesp is the appropriate drug of choice for more than the tightly defined population of patients who are diagnosed with chemotherapy-induced anemia, which is for what Aranesp is approved, according to the FDA letter.

The FDA also said Amgen exaggerated the number of Aranesp patients who could expect to avoid blood transfusion, while not providing sufficient details on appropriate dosing, the FDA wrote in the letter, according to a Law360 report.

Amgen Previously Involved in Misleading Marketing Claims Over Aranesp

Amgen is not a stranger to misleading marketing accusations. In a prior whistleblower claim made against the biotechnology company, Aranesp was one of two drugs that were the focus of illegal marketing claims.

Aranesp has long been known to increase cardiac problems in people who are prescribed the medication for the treatment of anemia.

While doctors are permitted to prescribe medications off-label, off-label marketing is illegal; programs such as Medicare also will not cover payment for drugs that are used off-label unless those off-label uses are established as being medically necessary. In fact, according to a prior Department of Justice (DOJ) statement under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Prior to approval, the FDA must determine a drug’s safety and efficacy; once approved, the drug maker may not market or promote the drug off-label.

The prior Amgen lawsuit, filed in 2007 on behalf of the United States and some states, found that the drug maker violated federal and state false claim laws, Medicare and Medicaid anti-kickback laws, and the U.S. Food, Drug and Cosmetic Act. This was done, according to documents, “by engaging in numerous unlawful activities in their marketing of Aranesp” and one other drug. The lawsuit also found that Amgen improperly marketed the attractive economics of Aranesp to customers; provided price discounts to customers, while hiding these discounts from government health programs, such as Medicare and Medicaid; Aranesp was marketed off-label for uses not approved by the FDA; and that off-label marketing occurred on Medscape, a WebMD-owned Internet site.

Prior to this, Amgen agreed to pay $200 million to Johnson & Johnson to settle allegations it violated antitrust laws. Amgen was accused of offering discounts to cancer clinics that would use Aranesp and other Amgen drugs.

Class Action Lawsuit for Patients of Aranesp

To find out more about joining a Aranesp class action lawsuit, please fill out our online form or contact one of our experienced product liability lawyers today at 1(800)-YOUR-LAWYER (1-800-968-7529).



 

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