China’s FDA (CFDA) has proposed a revised version of measures on how the Agency is going to deal with those found faking clinical trial data, while the country’s Supreme Court has passed in principle a judicial interpretation laying out the criminal laws applicable in such cases. According to the CFDA’s proposal, if a trial sponsor is found using fabricated data for drug registration, the agency will not accept its NDA (New Drug Application) for drugs in that same category for three years, as well as all NDAs for a year.
For those organizations that actually conduct trials — specifically certified hospitals in China — if fraudulent data are found, the organization will not be allowed to take on new trials or enroll new patients in ongoing trials, and all NDAs using its data will not be accepted until it carries out corrections and passes a third-party evaluation. If that institute does not pass the re-inspection, or if the Regulatory Body has found it faking data in three or more trials, the Agency will revoke it’s certificate and suspend Drug Applications it has taken part in, says the CFDA’s new proposal.
However, the agency still hasn’t laid out any regulatory punishments for CROs that coordinate trials, other than that the names of the CRO, the person there leading the trial project and the clinical trial associate involved in faking trial data — together with NDA applicants and trial-conducting organizations — will be put onto a black list available to the public. But it does say that CROs are directly responsible for trial reports and data they provide.
Administrative Regulation is as far as the CFDA can get; however, the country’s Supreme Court has brought the issue to the criminal offense level.
On the same day local time when the CFDA published its new proposal, China’s Supreme Court also issued a release (in Chinese) saying that it has in principle passed a judicial interpretation — usually considered as supplements to laws also with law-binding power — which for the first time specifies what existing criminal laws could be used in trial data fabrication cases. According to the interpretation, Drug Registration Applicants who are involved in fabricating data could be prosecuted with manufacturing and sales of fake drugs, a charge that usually imposes sentences shorter than three years in prison or jail, plus fines, while serious public health consequences could lead to more serious penalties all the way up to a death verdict.
Others taking part, including CROs, could be convicted with the crime of falsification of supporting documents; it’s verdict usually includes less than five (5) years in prison and a fine; however, the sentence could reach 10 years.
The interpretation will be revised as discussed during a meeting held by Chief Justice Zhou Qiang, and be officially published once the country’s Supreme Procuratorate co-signs it.
In the summer of 2015, the CFDA ordered companies behind 1,622 Drug Registration Applications to carry out “self-examination on the authenticity, integrity and compliance of clinical trial data.” About a year later, reports showed that companies had pulled about 80% applications, provoking wide criticism over the country’s drug R&D data integrity; and that was even before the Agency posted the first policy draft of how it intends to punish those found faking trial data.
The new proposal is a revision based on the 280 suggestions the agency gathered from last year, and it has ruled out submitting wrong data out of negligence rather than on purpose from its definition of data fabrication, according to a release (in Chinese) by the agency, which is soliciting public opinion until April 21.
REFERENCE: Fierce Biotech; 13 APR 2017; Agnus Liu