The U.S. Food and Drug Administration (FDA) just wrote to drug maker, Amgen Inc., about misleading marketing claims concerning its anemia drug, Aranesp (darbepoetin alfa).
The letter, not quite as serious as an agency warning letter, scolded the drug maker over its Aranesp direct mailers, which, according to the FDA, downplay possible ties to heart attacks and strokes while overstating the drug’s benefits. The “untitled” four-page agency letter accused the drug maker of presenting an incomplete Aranesp risk profile, according to a recent Law360 report.
The direct mailer does list a number of Aranesp side effects; however, the FDA indicated that there was no information on the drug’s ties to serious adverse responses such as death, heart attack, stroke, blood clots, a type of red blood cell disorder, and reduced hemoglobin levels, according to Law360. “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 agency wrote.
The Aranesp direct mailer brochure, wrote the FDA, rather than explicitly describing the adverse events, advised that a separate, included document contained complete prescribing information, as does the Aranesp website, Law360 reported. Regarding this, the agency wrote that, “These statements do not mitigate the misleading omission of important risk information from the direct mailer.”
Amgen was advised that it oversimplified how Aranesp works in various areas, noting that the oversimplifications could lead readers to think that Aranesp is the appropriate drug of choice in more than just the closely defined group of patients diagnosed with chemotherapy-induced anemia, the condition for which Aranesp is approved, according to the FDA letter, wrote Law360. A specific indication for Aranesp appears on page 3 of the pamphlet which, wrote the FDA, is not sufficient to eliminate “the overwhelming impression that Aranesp is useful in a much broader range of patients than has been demonstrated by substantial evidence or substantial clinical experience.”
The mailer also notes that the drug can deliver a “gradual and steady” hemoglobin level increase, pointing out that research supports the claim. According to the agency, wrote Law360, there is no science to back up this alleged benefit. The FDA also wrote that Amgen overstated the number of Aranesp patients who could expect to avoid blood transfusion, but did not provided sufficient details concerning appropriate dosing, according to a Law360 report.
Amgen, and two of its drugs, including Aranesp, were the focus of a prior whistleblower claim involving illegal marketing allegations. Although physicians are permitted to prescribe medications off-label—for uses not approved by the FDA—, off-label marketing is illegal. In fact, programs such as Medicare will not cover payment for medications used off-label unless those off-label uses are established as being medically necessary.
The 2007 lawsuit, filed on behalf of the United States and some states, found that Amgen violated federal and state false claim laws, Medicare and Medicaid anti-kickback laws, and the U.S. Food, Drug and Cosmetic Act “by engaging in numerous unlawful activities in their marketing of Aranesp” and one other drug, according to the documents. The lawsuit also found that Amgen improperly marketed the financial benefits of Aranesp and provided price discounts to customers, while hiding the discounts from government health programs, such as Medicare and Medicaid. Amgen was also found to have marketed Aranesp for off-label for uses, which occurred on Medscape, which is a WebMD-owned Internet site.
Prior to this lawsuit, Amgen agreed to pay $200 million to Johnson & Johnson to settle allegations that it violated antitrust laws. In that case, Amgen was accused of offering discounts to cancer clinics that agreed to use Aranesp and other Amgen drugs.