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    Home > Active Ingredient News > Drugs Articles > Review of "history" and "similarities and differences of clinical data falsification between China and the United States"

    Review of "history" and "similarities and differences of clinical data falsification between China and the United States"

    • Last Update: 2016-01-06
    • Source: Internet
    • Author: User
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    Source: Bio Valley / pancake fruit 2016-01-06 a brief review of 2015 clinical data fraud in China's pharmaceutical industry and 1989 US generics scandal just passed in 2015 As in 2007, it is destined to be an extraordinary year for China's Generics Industry The so-called "strictest" clinical trial data verification work has torn the veil of clinical data fraud in China's generic pharmaceutical industry There is a stark contrast between the tacit understanding of internal fraud and the public's fear of the quality of generic drugs in China, which makes people begin to doubt the supervision of the pharmaceutical industry and the integrity of pharmaceutical enterprises Is it "Chinese characteristics" to fake the data of long-standing clinical trials of drugs? Looking back on the history of the pharmaceutical industry, it is not difficult to find that as early as 30 years ago, the scandal of generic drugs in the United States was quite similar to the falsification of clinical trial data in the pharmaceutical industry in China today In 1989, hundreds of andas were finally withdrawn due to fraud and misrepresentation in US generic drug applications, and 22 companies and 70 individuals (pharmaceutical companies and FDA employees) were criminally convicted This also led to a serious shake in US public trust in generic drugs and FDA's ability to regulate the drug industry By comparing the similarities and differences of data fraud between China and the United States, we can draw more experience to guide the pharmaceutical industry on the right track, and at the same time, help the pharmaceutical industry consciously regulate their own behavior The similarities between the falsification of clinical trial data in China and the United States 1 The interest driven us generic drug scandal in 1989 originated from the pharmaceutical company mylan Its drug declaration is ahead, but it is not approved yet, while its competitor company's drug declaration is later, but it has been approved continuously By employing private detectives to investigate administrative officials, including technical officials of the FDA's generic drug review office, mylan found that it was some generic drug companies that reported false data in application materials, cheated and bribed FDA review officials, and got preferential approval In the face of a large amount of R & D investment but being cheated by others, mylan company will not give up, so the US generics scandal has been publicized However, the current approval sequence in our country is also based on "report first and review first" It can get the first imitation or enter the first echelon, which often indicates that the product will give back to the company in the future (of course, your sales team should be strong enough, otherwise it will be disgraced if you are followed by others) Without entering the top few enterprises, the cost of R & D in the early stage will also drift Even if it is finally approved and approved, it is difficult to occupy a place in the market of the same variety Now a generic drug variety from project approval to data application to clinical trials, often has tens of millions of investment, such a huge investment sometimes has to force enterprises to go astray, speculation is illegal As for the bribery review officials, Xiaobian suspects that since the "Zheng Xiaoyu case", China's CFDA is still trustworthy 2 Laws and regulations are not perfect, and the punishment is not enough in the US generic drug scandal, which leads to the public's distrust of FDA, which is more from the imperfection of laws and regulations and the insufficient punishment, so that the crime cost of some pharmaceutical companies is reduced Before the scandal, the FDA did not have a clear punishment policy for companies and parties involved in data fraud and bribery, which made many companies dare to take risks The introduction of the implementation act of generic drugs has opened the prelude to the strict supervision of generic drugs in the United States Since the requirement of drug registration was raised in 2007, the access threshold of generic drug quality has been greatly improved, which makes the quality of generic drugs in China have made a qualitative leap in the technical level, and the quality of many varieties has been comparable with that of large international pharmaceutical companies However, the corresponding laws and regulations are not clear enough, and the punishment is not enough, so it is impossible to fundamentally prevent the counterfeiting, bribery and other behaviors that harm the development of the generic pharmaceutical industry In 2015, CFDA's rectification of the pharmaceutical industry is bound to play a binding role, but in order to maintain long-term stability, the introduction of a law is even more expected 3 The means and methods of counterfeiting in the US generic drug scandal mainly focus on bioequivalence test For example, bioequivalence test is carried out by using the patent brand drugs purchased to pretend to be the generic drugs manufactured by ourselves In addition, it also openly sent a brand-new patent drug to FDA for inspection instead of its own generic drug samples In 2015, China's clinical data fraud also focused on bioequivalence Compared with the original drugs purchased by the United States to carry out the bioequivalence work of generic drugs, China's bioequivalence experimental data fraud is more diverse "Selective use data", "untrue test drug", "false data", "modified data", "incomplete original record", "data can not be traced", "concealing abandoned test data without giving reasons", "clinical trial process can not be traced", etc The final result of the U.S generic drug scandal is that hundreds of andas were eventually withdrawn, 22 companies and 70 individuals (pharmaceutical companies and FDA employees) were criminally convicted Up to now, hundreds of enterprises have voluntarily withdrawn their registration applications in China, and the number of registration applications voluntarily withdrawn is just around the corner China's drug audit center is mainly responsible for drug registration applications of domestic generic pharmaceutical enterprises, while the U.S FDA is facing global registration applications, which shows that the scale of drug clinical data fraud in China is really amazing 2 Different US generic scandals in the severely affected areas mainly focus on bioequivalence, and the experimental preparation comes from the original research preparation, mainly in terms of authenticity However, there are some problems in the authenticity, standardization and integrity of clinical trial data falsification in China In terms of authenticity, it is necessary to fabricate data, tamper with data, conceal data, the original data can not be traced, the test drug is not authentic, etc Standardization, integrity and other aspects such as lack of experimental data, violation of relevant provisions of GCP and so on 3 The technical content in the operation method is different The scandal cases of American generic drugs are mainly due to the problems in the source of drugs The bioequivalence test of the original research drug and the original research drug together is naturally satisfactory, which is easy to hoodwink the FDA review staff China's data fraud is relatively low-end There are many problems in the standardization and integrity of data These face-to-face projects are not willing to do The quality of generic drugs can be imagined Some examples of data fraud are even ridiculous Enterprises even take their own test samples as reference samples for experiments, which is a joke with the teachers of the drug audit center Think about the next stage of China's drug regulatory work through the U.S FDA's remedy for the scandal Here, Bio Valley editor believes that a strict law is the most effective solution In 1993, the United States promulgated the "generic drug Implementation Act", which amended the "food, drug and Cosmetics Act", provided preventive measures to prevent the cheating of drug registration application materials, authorized the FDA to rectify any criminal acts, and provided a mandatory permanent revocation of the qualification of cheaters in the pharmaceutical industry Not long ago, the State Food and drug administration, the Ministry of public security, the high court, the high inspection institute and the food safety office of the State Council jointly issued the measures for the connection of administrative law enforcement and criminal justice of food and drug The joint work of the five departments naturally improved the efforts of the State Food and Drug Administration in combating illegal crimes This is not only to give the General Administration of food and drug more rights, but also the determination of the state to rectify the pharmaceutical industry Although an excellent bill can't be issued in a hurry, the "working methods" can't be compared with the law after all, and the elimination of the industry needs a strict law.
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