Pharma marketing costs the most when it is not compliant to the regulations. Any unlawful or improper marketing campaigns in pharmaceutical can result in fines counted in billions of dollars. A report “Pharmaceutical Industry Criminal and Civil Penalties: An Update” by Public Citizen ranks the largest settlements by drugmakers, and shows these companies paid out 74 settlements to the tune of $10.2 billion from Nov. 2010 to July 2012. Public Citizen’s report does not include recent Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals settlement regarding Risperdal, Wellbutrin and Avandia misleading promotion.
Basing on the report of Public Citizen and U.S. Department of Justice data, K-message.com has compiled a list of top 5 most expensive failures of pharma marketing that resulted in heavy fines.
1. $3 000 000 000 – on 2nd of July 2012, GlaxoSmithKline LLC (GSK) has agreed to pay total 3 billion dollars to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices. There were three brands that GSK promoted against the law.
- The first, Paxil was unlawfully promoted for treating depression in patients under age 18, even though the FDA has never approved it for pediatric use. NB. Paxil, as other antidepressants, included on its label a “black box warning” stating that antidepressants may increase the risk of suicidal thinking and behavior in short-term studies in patients under age 18.
- The second brand included in the settlement was Wellbutrin. From January 1999 to December 2003, GSK promoted Wellbutrin, approved at that time only for Major Depressive Disorder, for weight loss, the treatment of sexual dysfunction, substance addictions and Attention Deficit Hyperactivity Disorder, among other off-label uses.
- The last brand involved was Avandia. In this case GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA. Since 2007, the FDA has added two black box warnings to the Avandia label to alert physicians about the potential increased risk of congestive heart failure, and myocardial infarction (heart attack). [Source]
2. $ 2 200 000 000 – on 30th of August 2013, Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals settled for 2.2 billion dollars in total multiple civil and criminal cases arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the U.S. largest long-term care pharmacy provider.
- Janssen Pharmaceuticals Inc., a J&J subsidiary, promoted the antipsychotic drug Risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion. The medicine was approved at the time only to treat schizophrenia. Risperdal was also promoted for use for elderly, children and individuals with mental disabilities, against repeated FDA warnings (Until 2006 Risperdal was not approved for use in children for any purpose). For all this groups drug posed certain health risks that J&J was aware.
- Similar allegations were made regarding to the newer J&J antipsychotic drug, Invega. Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.
- J&J and another of its subsidiaries, Scios Inc., caused false and fraudulent claims to be submitted to federal health care programs for the heart failure drug Natrecor. In August 2001, the FDA approved Natrecor to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity. Government alleged that, shortly after Natrecor was approved, Scios launched an aggressive campaign to market the drug for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the FDA-approved label and not covered by federal health care programs. Scios had no sustainable evidence to support medical necessity of these outpatient infusions. [Source]
3. $1 500 000 000 – on 7th of May 2012, Abbott Laboratories Inc. has agreed to pay $1.5 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration.
- Abbott admits that from 1998 through 2006, the company maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use. In addition, from 2001 through 2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use. The FDA approved Depakote for only three uses: epileptic seizures, bipolar mania and the prevention of migraines. [Source]
4. $1 200 000 000 – on 11th of July 2012 a judge in Arkansas ordered Johnson & Johnson and its subsidiary Janssen to pay more than $1.2 billion in fines on Wednesday, a day after a jury found that the companies had minimized or concealed the dangers associated with an antipsychotic drug Risperdal. For details of the allegations see number 2 of this list. Risperdal case generated also other, smaller fines in Texas ($158 million), South Carolina ($327 million) and Louisiana ($258 million). [Source]
5. $950 000 – on 22nd of November 2011, an american pharmaceutical company Merck, Sharp & Dohme has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx® (rofecoxib).
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Rofecoxib (Photo credit: Wikipedia)
Merck’s criminal plea relates to misbranding of Vioxx® by promoting the drug for treating rheumatoid arthritis, before that use was approved by the Food and Drug Administration. The FDA approved Vioxx® for three indications in May 1999, but did not approve its use against rheumatoid arthritis until April 2002. In the interim, for nearly three years, Merck promoted Vioxx® for rheumatoid arthritis, conduct for which it was admonished in an FDA warning letter issued in September 2001. Additionally Merck representatives made inaccurate, unsupported, or misleading statements about Vioxx’s cardiovascular safety in order to increase sales of the drug. [Source]
