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Benicar Kickback Settlement and FDA Warnings

Daiichi Sankyo paid $39 million to settle a criminal case involving Benicar. The U.S. Justice Department accused the company of paying doctors to prescribe the drug. The U.S. Food and Drug Administration accused Daiichi Sankyo of misleading the public.

Benicar Government Penalties Facts
  1. Manufacturer: Daiichi Sankyo
  2. Government Agencies Taking Action: FDA and U.S. Justice Department
  3. Fines and Penalties: $39 million settlement
  4. Allegations: Paying kickbacks to doctors, improper marketing, minimizing risks
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Daiichi Sankyo gave doctors illegal payments known as kickbacks, according to the U.S. Justice Department. The payments were to encourage doctors to prescribe Benicar.

In 2015, the company agreed to pay $39 million to settle the criminal case. It also said it would put in place reforms for five years.

Daiichi Sankyo also faced FDA action over the marketing of Benicar as far back as 2006. The U.S. Food and Drug Administration said the marketing violated the federal rules.

$39 Million Benicar Kickback Settlement

In 2015, Daiichi Sankyo agreed to pay $39 million to the U.S. and state Medicaid programs. The settlement payment resolved allegations that the company violated the False Claims Act.

The law tries to stop drug companies from giving doctors gifts or payments to prescribe a drug.

False Claims Act
False Claims Act tries to stop drug companies from giving doctors gifts or payments to prescribe a drug.

The U.S. Justice Department accused Daiichi of paying physicians speaker fees. The fees were part of Daiichi’s Physician Organization and Discussion programs. The programs ran from January 2005 to March 2011 and from January 2004 to February 2011.

Some of the speaker programs involved lavish dinners. The dinners each cost more than $140 per person.

Sometimes, the speaker programs meant doctors talked to their own staffs. In other programs, doctors spoke to other members of the speakers’ program.

As part of the settlement, Daiichi signed a corporate integrity agreement. The agreement requires the company to put in place reforms for five years.

The settlement was a result of a case brought by a whistleblower, Kathy Fragoules. Fragoules was a former Daiichi sales representative. She was to receive $6.1 million of the payment.

Benicar Misleading Marketing

The FDA warned Daiichi Sankyo more than once about marketing that was misleading. The agency noted misbranded information on Benicar and its alleged effectiveness.

The marketing materials promoted Benicar to consumers as the best drug in its class. This presumably led to prescriptions doctors otherwise might not have written.

The marketing also left out or played down certain risks associated with taking the drug.

FDA Violations

In 2006, the FDA issued a warning letter to Sankyo. The agency advised the Sankyo that its promotional materials violated FDA regulations. At the time, Sankyo had not yet merged with Daiichi.

The letter said Sankyo distributed marketing materials that suggested Benicar was the best. The company also suggested Benicar was more effective than competitors.

The FDA said there was not enough evidence to support the claims made in the marketing materials.

In late 2013, the FDA again warned Daiichi about misleading Benicar marketing materials.

Benicar Promotions Downplayed or Omitted Risks

The warning letter also said Sanyko left out or minimized risk information.

The FDA accused Sankyo of omitting or downplaying information on risks during pregnancy.

Sankyo also left out or minimized information for patients with renal artery stenosis. Renal artery stenosis is the narrowing of arteries that carry blood to one or both kidneys. Renal artery stenosis is the narrowing of arteries that carry blood to one or both kidneys.

Other omitted or minimized risks involved:

liver pain icon
patients with impaired liver function
lupus icon
patients with systemic lupus erythematosus
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patients taking the drug lithium

Please seek the advice of a medical professional before making health care decisions.

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4 Cited Research Articles

  1. FDA. (2013). RE: NDA # 021286 & 021532. Retrieved from https://www.fdanews.com/ext/resources/files/11/11-08-13-UntitledLetter.pdf
  2. FDA. (2006). Warning Letter. Retrieved from http://www.wlf.org/Upload/DDMwrnBenicar.pdf
  3. FDA. (2013). FDA Drug Safety Communication: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm359477.htm#tabs-5
  4. U.S. Department of Justice. (2015, January 9). Daiichi Sankyo Inc. Agrees to Pay $39 Million to Settle Kickback Allegations Under the False Claims Act. Retrieved from https://www.justice.gov/opa/pr/daiichi-sankyo-inc-agrees-pay-39-million-settle-kickback-allegations-under-false-claims-act
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