2015年11月15日星期日

Clinical trials for fraud penalties too light

Clinical trial data recently, China Food and Drug Administration announced that eight pharmaceutical companies 11 drug applications for registration untrue, incomplete, decided not to approve its application for registration, five institutions involved in clinical trials are the top three public hospitals, to initiate an investigation.
You should see, the State Food and Drug Administration on July 22 this year, released the so-called "history of the most stringent data verification requirements of" Notice (No. 117 text), requiring pharmaceutical companies to self-examination, otherwise the discovery data fraud will be severely dealt with in its verification, . After more than a month, self-examination results were out, the original number received in 1622, pharmaceutical companies guilty withdraw 20% of the registration application. 11 test data found fake drugs now, you should belong to their own situation did not withdraw the application and approval procedures are found in the.
Clinical trials of drugs, is a prerequisite for the approval of new drugs, millions of people related to drug safety, but also a sacred cause. Now he was exposed pharmaceutical companies and clinical trials hospital collusion, a large area of ​​the phenomenon of false test data, in particular should have "life-saving for the bounden duty," the top three public hospitals, will also participate in fraud, which is the "intentional homicide" Yi? If you miss the patients' lives, "who bear its responsibility? No wonder netizens feel both "before the fear of" also "scared." "Before the fear" that in the end how many such substandard drugs has flowed into society, many people's physical and mental harm and life; "scared" is relevant to investigate the breadth, depth and intensity, can be completely into the community The channel cut off it?
Clinical trial data fraud so serious, is not suddenly emerge as a new disease. State Food and Drug Administration who had admitted that "drug approval clinical data fraud is already an open secret in the industry, not an isolated phenomenon, but rather a common phenomenon," period "from 2007 to 2008, and then every two or three years, the State Food Drug Administration have focused on consolidation, but so far, the chaos has not been effectively curbed, "a serious problem to the extent evident.
Investigate clinical trials data fraud, not without national legal basis. "Drug Administration Law" stipulates that drug manufacturers, drug clinical trial institution is not in accordance with the implementation of Good Clinical Practice (GCP), and given a warning and ordered to make corrections; overdue correction shall be ordered to stop production, suspend business for rectification, and impose a five thousand yuan to 20,000 yuan fine; circumstances are serious, revoked "drug production license" and drug clinical trial institution qualification.
The competent authorities in accordance with the argument, long-standing problem, logically there should be some units that investigate announcements and warnings, but in public information due to clinical trial data fraud investigation by pharmaceutical companies, almost one case related to hospitals are not retrieved. The Food and Drug Administration hospital system than someone direct filing, indeed quite obviously determined: Only when this "thorough investigation to punish" has become the norm, the probability of illegal promotion by the investigation, which had itself the only hazard fraud You will be curbed.
From this investigation pharmaceutical companies and public hospitals, the administrations ability to identify problems, no doubt. But now, the relevant sanctions does not match the extent of its bad behavior: pharmaceutical companies currently involved in clinical trials for fraud data, clinical trials institutions, contract research organizations and their direct responsibility, the punishment is blacklisted, and to Social publish relevant organization code, identity card numbers and other personnel, suspected of a crime, the transfer of public security organs investigation.
But taking into account this "blacklist" just inside outward publish some of the "code" and "number" are not really even punishment (is not punishment species), which from the public expected "punish" Obviously there is distance. 117 paper, "the most stringent standards, the most stringent regulation, the most severe punishment, the most serious accountability", the legal aspects of the "bell" is the basic premise, which include administrative accountability. Even if the administrative responsibility could not see, so-called transfer of suspected criminal justice, is the feint.

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