Shire Pharmaceuticals agreed to pay states and the federal government a total of $56.5 million to settle allegations of unlawful drug marketing and promotion, The National Law Review reported. The international drug manufacturer reportedly made unfounded claims for more than six years about products that treat attention deficit hyperactivity disorder and ulcerative colitis. Those medications included Adderall XR, Daytrona, Lialda, Pentasa and Vyvanse.
"Under the False Claims Act, it is unlawful for any individual or company to knowingly commit healthcare fraud against the government by misrepresenting a product through false advertisement, billing the government for a product or service that is not necessary, or engaging in unlawful drug marketing and promotion practices," The National Law Review noted.
Part of the settlement alleges that Shire deliberately encouraged practitioners to prescribe its products for off-label (or non-approved) purposes and by so doing may have jeopardized patients' health. Further, Shire reportedly touted Adderall XR as clinically superior to other ADHD drugs on the market despite insufficient clinical data to support that claim.
Four whistleblowers in this case --all former Shire employees --will share an award of $5.9 million, or 16.2 percent, of the settlement, the article noted.
Of the total settlement, $48.1 million will go to state Medicaid programs, according to the Norwalk Reflector. Ohio's share, for example, will be just over $2 million.
"This settlement is significant for Ohio because it is one of the first national settlements in which Medicaid managed care damages, as well as fee-for-service damages, have been calculated and included as part of the recovery in a settlement," Ohio attorney general Mike DeWine told the newspaper.
Shire was fully cooperative throughout the investigation, the Reflector reported. Further, the drug maker entered into a corporate integrity agreement with the Department of Health and Human Services, which will keep a close eye on Shire's future drug marketing and sales activities.