What can China learn from US FDA events?
Dr. Bob Roehr shared the news of the investigative report about outlining conflicts of interest among individuals employed by the FDA [1-2], raising worldwide concern. The report has led Chinese doctors to be concerned whether a similar phenomenon occurs at the CSDA (China State Drug Administration), whose predecessor is the CFDA (China Food and Drug Administration).
In 2017, the CFDA completed 9680 drug-related registrations and new drug applications, while also having approved 394 new drugs . The work of the CFDA is heavy, and with many employees the opportunity for a conflict of interest exists; the likelihood of a drug inspector approving a drug is potentially high. In 2006, such related problems occurred at the CFDA, and as a consequence the government rigorously implemented strict penalties in an effort to solve the problem . In recent years, the CFDA has continuously consulted members of Chinese society to improve the system. In March, 2018, the CFDA implemented further changes and had a new name for the organization, China State Drug Administration (CSDA).
Both the FDA and CSDA have strict regulations on their employees’ conflicts of interest. However, the investigate report uncovers little recognized and unpoliced potential conflicts of interest among those who serve on FDA advisory panels that review drugs [1-2]. Given the number of advisors working at the CSDA, one may wonder whether this is also occurring at the CSDA. This potential for conflicts of interests of advisors highlights the need for increased government regulation in this field.
Besides, the other report from Science revealed that a number of former FDA staff were employed by or consulted with companies that they had recently regulated at the FDA . Whether this phenomenon is occurring at the CSDA is currently unknown.
In conclusion, we have several suggestions:
1. To CSDA or FDA staff, rules should be enforced so individuals planning on consulting or working for companies they have regulated during their employment at the CSDA or FDA must report their plan to their respective Drug Administration organization prior to taking action.
2. To the advisory panels, advisors should review drugs in a setting where external communication is blocked. If the advisors want to get the research funding from the companies they had reviewed in the past, the individual must report to the CSDA or FDA for approval. If there is any conflict of interest before the drug review, the advisor needs to be removed.
Changjing Cai, M.D 1, 2, Hong Shen, Ph.D 1,3, Shan Zeng, M.D, Ph.D 1, 2, *
1 Department of Oncology,
2 National Clinical Research Center for Geriatric Disorders,
3 Key Laboratory for Molecular Radiation Oncology of Hunan Province, Xiangya Hospital, Central South University, Changsha, Hunan, China 410008
* Corresponding Author: Shan Zeng, M.D, Ph.D, Department of Oncology, Xiangya Hospital, Central South University, Changsha, Hunan, China 410008. E-mail: firstname.lastname@example.org.
. Roehr B. FDA advisers were paid $10 000 to $1.9 m for future industry work[J]. 2018. 362:k2942
. Piller, Charles. Hidden conflicts? [J]. Science, (2018), 361 (6397): 16-20.
. China Food and Drug Administration. The drug review report of 2017 [Chinese]. 2018. http://samr.cfda.gov.cn/WS01/CL0844/226865.html
. News of the Communist Party of China. China Food Safety Head Zheng xiaoyu was Executed in the morning [In Chinese]. 2007. http://cpc.people.com.cn/GB/64093/64371/5969158.html
. Piller C. Is FDA's revolving door open too wide? [J]. Science, (2018), 361 (6397): 21.
Competing interests: No competing interests