Edited by Heather Martin
“$2.2 Billion Fine for Johnson & Johnson in the US,” Why the Discomfort?
Regarding the question of whether pharmaceutical companies in China, including Johnson & Johnson, sell drugs for unapproved off-label uses, the Chinese government should not remain silent but raise its authoritative voice in a timely manner. If violations do exist, sales of the drugs promoted for unapproved uses should be halted and recovery penalties should be issued for the company. And that is a responsible attitude for the public.
A settlement of $2.2 billion linked U.S. company Johnson & Johnson again with the pharmaceutical industry’s unspoken rule of off-label promotion. On June 11, Johnson & Johnson agreed to pay $2.2 billion to settle the U.S. government’s investigations on its antipsychotic prescription drug Risperdal — risperidone — and several other drugs. Johnson & Johnson was accused of promoting these drugs for unapproved off-label uses. Some media pointed out that Johnson & Johnson in China, on the contrary, was left intact (June 13, “The First Financial Daily”).
People do not understand why the same business promotion faced two distinct treatments: In the U.S., it was considered a misdemeanor criminal offense with heavy fines as punishment, while in China it was perfectly fine?
Taking Risperdal as an example, Johnson & Johnson declared that the drug could be used for the treatment of bipolar disorders without the approval of the U.S. Food and Drug Administration. By contrast, the Johnson & Johnson subsidiary Xian Janssen stated that drug use for bipolar disorders had been officially approved in China and thus, the aforementioned allegation did not apply to Johnson & Johnson China. Was Janssen’s statement true? If so, the company marketed and sold the same drugs in the same way, so why did the same business practices become legitimate in China?
In China, drug promotion for unapproved off-label use is a new but important topic. In accordance with basic international practices, the pharmaceutical companies, for commercial purposes, intentionally encourage off-label drug uses. These drugs were not tested in large-scale clinical trials and therefore carry high risks. If considering the public interest, the government should prohibit such drug promotions and have a zero tolerance attitude.
In the U.S., Roche, Pfizer, Eli Lilly and other international pharmaceutical giants have all been fined for off-label drug promotion. In October 2009, Pfizer was fined $2.3 billion, which was the largest fine by the Ministry of Justice and was the largest healthcare scam in U.S. history. In sharp contrast, there has never been any punishment for off-label drug promotion in China. What does this discriminatory law enforcement attitude tell us?
Is it because in China these pharmaceutical companies are particularly "honest" and never promote drugs for “off-label uses?” The answer is certainly “no.” The fundamental difference is that our drug administration and other functional departments may not yet be accustomed to this kind of law enforcement. Not long ago, a new drug called Xarelto by Germany's Bayer was accused of unapproved off-label promotion in China. Qiang Zhang, the vascular surgery director of East Hospital affiliated with Tongji University, published a statement on his blog that Bayer was suspected of conducting off-label promotions for its clot-prevention drug, Xarelto. Nonetheless, the incidence, due to the silence and nonintervention of the government authorities, ended only as a quarrel between two parties.
Regarding the question of whether pharmaceutical companies in China including Johnson & Johnson sell drugs for unapproved off-label uses, the Chinese government should not remain silent but raise its authoritative voices in a timely manner; if violations do exist, the alleged product should be put on halt and recovery penalties should be issued for the company. And that is a responsible attitude for the public.
A settlement of $2.2 billion linked U.S. company Johnson & Johnson again with the pharmaceutical industry’s unspoken rule of off-label promotion. On June 11, Johnson & Johnson agreed to pay $2.2 billion to settle the U.S. government’s investigations on its antipsychotic prescription drug Risperdal — risperidone — and several other drugs. Johnson & Johnson was accused of promoting these drugs for unapproved off-label uses. Some media pointed out that Johnson & Johnson in China, on the contrary, was left intact (June 13, “The First Financial Daily”).
People do not understand why the same business promotion faced two distinct treatments: In the U.S., it was considered a misdemeanor criminal offense with heavy fines as punishment, while in China it was perfectly fine?
Taking Risperdal as an example, Johnson & Johnson declared that the drug could be used for the treatment of bipolar disorders without the approval of the U.S. Food and Drug Administration. By contrast, the Johnson & Johnson subsidiary Xian Janssen stated that drug use for bipolar disorders had been officially approved in China and thus, the aforementioned allegation did not apply to Johnson & Johnson China. Was Janssen’s statement true? If so, the company marketed and sold the same drugs in the same way, so why did the same business practices become legitimate in China?
In China, drug promotion for unapproved off-label use is a new but important topic. In accordance with basic international practices, the pharmaceutical companies, for commercial purposes, intentionally encourage off-label drug uses. These drugs were not tested in large-scale clinical trials and therefore carry high risks. If considering the public interest, the government should prohibit such drug promotions and have a zero tolerance attitude.
In the U.S., Roche, Pfizer, Eli Lilly and other international pharmaceutical giants have all been fined for off-label drug promotion. In October 2009, Pfizer was fined $2.3 billion, which was the largest fine by the Ministry of Justice and was the largest healthcare scam in U.S. history. In sharp contrast, there has never been any punishment for off-label drug promotion in China. What does this discriminatory law enforcement attitude tell us?
Is it because in China these pharmaceutical companies are particularly "honest" and never promote drugs for “off-label uses?” The answer is certainly “no.” The fundamental difference is that our drug administration and other functional departments may not yet be accustomed to this kind of law enforcement. Not long ago, a new drug called Xarelto by Germany's Bayer was accused of unapproved off-label promotion in China. Qiang Zhang, the vascular surgery director of East Hospital affiliated with Tongji University, published a statement on his blog that Bayer was suspected of conducting off-label promotions for its clot-prevention drug, Xarelto. Nonetheless, the incidence, due to the silence and nonintervention of the government authorities, ended only as a quarrel between two parties.
Regarding the question of whether pharmaceutical companies in China including Johnson & Johnson sell drugs for unapproved off-label uses, the Chinese government should not remain silent but raise its authoritative voices in a timely manner; if violations do exist, the alleged product should be put on halt and recovery penalties should be issued for the company. And that is a responsible attitude for the public.
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