Cao Wenzhuang's Criminal Facts

From June 5438+February 2003 to September 2005, the defendant Cao Wenzhuang took advantage of his position as the director of the National Drug Registration Department and accepted the entrustment of Wei Wei and Liu Yuhui (both handled separately) to seek benefits for enterprises such as Jilin Weiwei Company and Guangzhou Baiyunshan Company respectively. Therefore, Cao Wenzhuang accepted RMB 6,543.8 +0.5 million and US$ 6,543.8+0,654.38+0.0 million from Wei Wei, which was equivalent to RMB 2,406,746. The specific criminal facts are as follows:

(1) Defendant Cao Wenzhuang took advantage of his position to accept Wei Wei's request from February 2003 to February 2005 to help Yanduqing Injection produced by Jilin Weiwei Company pass the examination of the State Food and Drug Administration. Therefore, Cao Wenzhuang received US$ 90,000 from Wei Wei and RMB 165438+ 10,000 from Wei Wei through Liu Yuhui three times, equivalent to RMB 1844902.

The above facts are confirmed by the following evidence provided and cross-examined by our hospital: 1. Witness Wei Wei's testimony proves that at the beginning of 2003, the "Roadside Clear Injection" produced by Jilin Weiwei Company was examined by the State Administration of Pharmaceutical Products, and the relationship was cleared in the Drug Registration Office of the State Administration of Pharmaceutical Products through Liu Yuhui. From June, 5438 to February, 2003, Liu Yuhui proposed that Cao Wenzhuang, Director of Drug Registration Department, hold a birthday party for him to introduce him to Cao Wenzhuang. He took $65,438+00,000 as a birthday present and gave Liu Yuhui an envelope containing $65,438+00,000 in the hotel opposite Beijing Xijiao Cancer Hospital. Liu Yuhui was introduced to Cao Wenzhuang in the same position in the hotel; Before the Spring Festival in 2004, Liu Yuhui informed him that Cao Wenzhuang had agreed to help him and asked him to go to Cao Wenzhuang's office with Liu Yuhui to give him some gifts. He came to Liu Yuhui's office with $30,000. Liu Yuhui took out two tea cones and put the dollars in. The two went directly into Cao Wenzhuang's office and gave them to Cao Wenzhuang on the grounds of sending tea gifts during the Spring Festival. Cao Wenzhuang did not return it after accepting it; Before the Spring Festival in 2005, he gave Cao Wenzhuang US dollars 1 0,000 yuan in his office on the grounds of visiting Cao Wenzhuang during the Spring Festival. After the Spring Festival, he received a phone call from Cao Wenzhuang, asking about "roadside injection" and asking him to meet in Cao's office. He thought Cao Wenzhuang's purpose was to get him to send more gifts. Before going to work the next day, he came to Cao Wenzhuang's office with $50,000. After the meeting, he put the paper bag containing US dollars on the cabinet of Cao Wenzhuang's office, and asked Cao Wenzhuang to be responsible for the review of "roadside injection". Cao Wenzhuang said no problem. Cao Wenzhuang gave him two boxes of "licorice refreshing buccal tablets". Back in the car, Cao Wenzhuang called him and told him that the 1 0,000 dollars sent before the Spring Festival was put in the medicine box for him to check, and the 50,000 dollars sent that day was accepted by Cao Wenzhuang. Cao Wenzhuang just returned this gift to him. Cao Wenzhuang accepted his USD 90,000; About May 2004, before and after learning that the drug was about to pass the re-inspection, he handed over RMB 165438+ 10,000 Yuan to Cao Wenzhuang twice from Liu Yuhui near his residence. "Roadside Clear Injection" was renamed as "Yanduqing Injection", and finally passed the evaluation in the drug registration department of the US Food and Drug Administration, and obtained the approval number in June 2005, subject to the approval of Cao Wenzhuang.

2. The testimony of witness Liu Yuhui proves that Wei Wei was introduced by others in March 2003. Wei Wei asked him to examine "Roadside Clearing Injection" (later renamed as "Yanduqing Injection") in the State Administration of Pharmaceutical Products, so as to smooth the relationship. He handed Wei Wei's application to Cao Wenzhuang, hoping that Cao could help Wei Wei's enterprise. Soon, he saw Cao Wenzhuang's instructions in the office of Xie Shichang, director of the Chinese Medicine Department of the Drug Registration Office: "This material was brought by Liu Yuhui, so please study it by the Chinese Medicine Department." Xie Shichang said that it is very difficult. However, at the internal meeting held by the Drug Registration Department on June 5438+ 10, 2003, it was finally decided that "roadside clear injection" could participate in the evaluation. From June 5 to February 2003, Cao Wenzhuang held a birthday party in Yongxing Garden Hotel, Haidian District, Beijing. He invited Weiwei to the hotel to introduce him. Wei Wei said that he gave Cao Wenzhuang dollars as a birthday present. At that time, according to the thickness of the US dollar envelope given to him by Wei Wei, it should be about $20,000. He directly put the envelope in a black cloth bag that Cao Wenzhuang carried with him. Before the Spring Festival in 2004, Wei Wei wanted to go with him to see Cao Wenzhuang for drug evaluation, and then came to his office with a bank bag. From the outside, it is about 20,000-30,000 dollars. He said it was not a good way to go. Why don't you go in the name of a holiday gift and give Cao the US dollars? Weiwei put the dollars in a tea cone and then put them in a paper bag. He accompanied Wei Wei to Cao's office and introduced Wei Wei's visit to Cao Wenzhuang. Then he waited for Wei Wei in the corridor. Soon, I saw Wei Wei coming out of Cao's office, and the paper bag in his hand was gone. It should be for Cao Wenzhuang. From April to May, 2004, because the National Drug Evaluation Center of the US Food and Drug Administration has accepted the evaluation of "Roadside Clear Injection", it is not far from the official production of the announced product. Wei Wei invited him to Wei Wei's residence in Beijing twice and gave him RMB 165438+ 10,000, hoping to give it to Cao Wenzhuang. Thank you for your help in the drug review. All of them were handed over to Cao Wenzhuang on the night of receiving Wei Wei's money. He didn't dare to withdraw some money from this 165438+ ten thousand yuan, because Wei Wei often contacted Cao Wenzhuang at that time. If found, he can't find Cao Wenzhuang to handle affairs. Cao Wenzhuang contributed a lot to the review of roadside clearing notes. In June, 2005, Jilin Weiwei Company finally got the "National Standards for Chinese Patent Medicines Promulgated to Solve the Rising of Local Standards".

3. The testimony of witness Xie Shichang (then Director of Chinese Medicine Division of Drug Registration Department of State Pharmaceutical Product Supervision Administration and Director of Chinese Medicine Division of State Drug Registration Department) proves that Cao Wenzhuang had an instruction to ask Comrade Shichang to read it (with Comrade Liu Yuhui) in the Request for Instructions on Reviewing Local Standard Variety "Roadside Clear Injection". Because the close relationship between Liu Yuhui and the drug registration department is well known, it shows that Cao Wenzhuang is very concerned about this variety evaluation.

4. The testimony of witness Ma Guanglin (a staff member of the Chinese Medicine Department of the State Drug Registration Department) proves that after the rectification of local standards of proprietary Chinese medicines ended at the end of 2002, many unqualified varieties were re-examined by the Chinese Medicine Department of the Drug Registration Department of the State Drug Administration. The "Request for Instructions on Checking Anti-cold Drugs and Other Varieties by Jilin Provincial Bureau" was drafted by it and approved by the director and deputy director in turn. Finally, Cao Wenzhuang, the director, signed the "consent" opinion and adopted the method of circle reading.

5. Application certificate for registration of Yanduqing Injection issued by the US Food and Drug Administration: establishment and change of Weiwei Company in Jilin Province; "Roadside Clear Injection" was renamed as "Yanduqing Injection"; Jilin Weiwei Company submitted a review to the State Administration of Pharmaceutical Products in March 2003; On April 1 day, 2003, Cao Wenzhuang gave an instruction of "Please read it by Comrade Shichang (with Comrade Liu Yuhui)" for the reexamination request of the local standard variety "Roadside Clear Injection"; On February, 2004, No.65438, Cao Wenzhuang read the "Request for Instructions on Handling Opinions of Jilin Provincial Bureau on Inspection of Anti-cold Drugs and Other Varieties" (including "Roadside Clear Injection") and gave the instructions of "consent"; Review of "Roadside Clear Injection" by the State Administration of Pharmaceutical Products: In June 2005, the State Food and Drug Administration of the United States issued the national drug standard for Yanduqing Injection (for trial implementation).

6. Certificate of foreign exchange quotation issued by Bank of China Beijing Branch: the exchange rate between the US dollar and RMB during the relevant period.

7. Defendant Cao Wenzhuang's confession during the investigation: In March 2003, he was given a letter from Jilin to apply for the reexamination of "Roadside Clear Injection", saying that the variety belonged to Liu's friend Wei Wei and asked him to help him participate in the reexamination. He gave instructions on asking for instructions and let Comrade Xie Shichang of Chinese Medicine Department handle it. Later, "roadside clear injection" was treated according to the local standard of Chinese patent medicine. On June 30, 2004, 165438+ Ma Guanglin wrote a request for instructions on the handling of "roadside cleaning injection", which stated that the US Food and Drug Administration of Jilin claimed in its letter that the production approval form had the same effect as the original production approval form, and suggested that it should be handled according to procedures. Now, if problems are found, study them and deal with them separately. On this request, it signed the Consent, which finally helped Jilin Weiwei Company pass the drug evaluation. In the meantime, from April to May, 2003, Wei Wei and Liu Yuhui came to his office. When Wei Wei left, she put down a paper bag. Later, he opened it and found that there was $30,000 in the safe at home. At the end of 2003, at Yongxing Garden Hotel in Haidian District, Liu Yuhui organized a birthday party for him, and Wei Wei also attended. After the party, Liu Yuhui put an envelope in his black canvas bag and told him that it was a birthday present from Vivian. When I got home, I found $6,543,800+in it and put it in the safe. On June 5438+ 10, 2004, he called Wei Wei to get materials from his office, and returned the $40,000 that Wei Wei gave him from September to June 5438+ 10, 2003 to Wei Wei in the box of "licorice Houyi buccal tablets". However, when Weiwei came, she brought a paper bag. After Wei Wei left, she found that there were 40,000-50,000 dollars in it, and she took it and put it in the safe. Around May 1, 2004, Wei Wei sent him RMB 165438+ 10,000 yuan through Liu Yuhui to thank him for helping the roadside injection pass the evaluation.

(2) Defendant Cao Wenzhuang took advantage of his position to accept Liu Yuhui's request to help speed up the registration and approval of "antivirus soft capsules" declared by Guangzhou Baiyunshan Company. Therefore, Cao Wenzhuang received RMB 400,000 and US$ 20,000 from Liu Yuhui twice in September 2005, equivalent to RMB 56 18440.

The above facts are confirmed by the following evidence presented in court and cross-examined, which is confirmed by our court:

1. Witness Liu Yuhui's testimony proves that Guangzhou Baiyun Mountain Company was appointed as the general manager after its establishment, and the "antivirus soft capsule" declared by the company to the State Pharmaceutical Products Supervision and Administration Bureau was not approved. In May 2003, Cao Wenzhuang invited the Drug Evaluation Center to help speed up the drug registration and approval of "antivirus soft capsules", and in June 2003, he obtained the production approval issued by the US Food and Drug Administration. In 2005, Cao Wenzhuang was the backup candidate of the US Food and Drug Administration, the deputy director of the country, but there was no news. He discussed with Cao Wenzhuang and prepared some money for Cao to use in the operation and promotion of the deputy director. On a weekend in September 2005, he accompanied Cao Wenzhuang and others to play ball games and have dinner, and then drove Cao Wenzhuang to his residence by himself, giving him RMB 400,000 prepared in advance. On the eve of National Day, he gave Cao Wenzhuang $20,000 in his office.

2. Witness Zhang Xianglin's testimony proves that in 2003, Guangdong wrote to the State Medical and Drug Administration, claiming that the "anti-virus soft capsule" declared by Guangzhou Baiyun Mountain Company had a certain effect on SARS. Cao Wenzhuang instructed to forward this letter to the drug evaluation center and write a letter, the content of which is to let the drug evaluation center speed up the evaluation of drugs. Because of the inconvenience of rigid requirements, Cao Wenzhuang used drugs to treat SARS as an excuse, hoping to speed up the evaluation. This variety is not included in the drugs for treating SARS. According to the comprehensive evaluation opinions of the drug evaluation center, it is only evaluated as a general drug. In the letter written by Cao Wenzhuang, the opinion that "it must be accelerated" was signed. Finally, the review time of "Antivirus Soft Capsule" is 10 to 15 working days earlier than the standard review time.

3. The testimony of witness Wu Zhi 'ang (then deputy director of the Drug Evaluation Center of the State Pharmaceutical Product Supervision Administration and the deputy director of the Drug Evaluation Center of the State Food and Drug Administration of the United States) confirmed Zhang Xianglin's testimony. At the same time, it is proved that the evaluation of "anti-virus soft capsules" is completed 15 working days ahead of schedule, which means that the production approval should be obtained one month earlier than other drugs declared in the same period, and the profits obtained by enterprises will be much higher than those declared in the same period.

4. Certificate of application for registration of "antivirus soft capsule" issued by the State Food and Drug Administration of the United States: industrial and commercial registration of Guangzhou Baiyun Mountain Company; Information and statement about "antivirus soft capsules"; Cao Wenzhuang gave an instruction to "ask the center to speed up the review as appropriate" in the Letter on Reporting the Rapid Approval of Antiviral Soft Capsules, and sent a letter to ask Zhang Xianglin and Wu Zhiang, the drug evaluation center, to help speed up the drug review; June 5438+October 2003 10, Cao Wenzhuang signed the approval document of drug registration "Ministry review"; 165438+October 2003. "Anti-virus Soft Capsule" has obtained the new drug certificate issued by the State Food and Drug Administration of the United States.

5. Certificate of foreign exchange quotation issued by Bank of China Beijing Branch: the exchange rate between the US dollar and RMB during the relevant period.

6. Defendant Cao Wenzhuang confessed in the investigation organ: In July, 2003, Liu Yuhui handed him a "Quick Request Letter on Applying for Antiviral Soft Capsules" issued by the US Food and Drug Administration of Guangdong Province, which mentioned that the drugs developed by Guangzhou Baiyunshan Company operated by Liu Yuhui were effective in treating SARS virus, and requested to speed up the examination and approval. So he gave instructions in the letter, asking the drug trial center to speed up the examination and approval as appropriate. With its help, the drug evaluation center accelerated the examination and approval speed, and the drugs passed the examination and approval smoothly. One night after the Mid-Autumn Festival in 2005, Liu Yuhui accompanied him to play ball with Liu Gang and Zhang. After dinner, he drove him home. When getting off the bus, Liu Yuhui handed him a paper bag, saying that it could be operated and promoted to deputy director. After investigation, there was RMB 400,000 in it, which was put in the safe at home; The day before National Day, Liu Yuhui gave him $20,000 in his office. Having been in contact with Liu Yuhui for many years, all major pharmaceutical companies know that Liu Yuhui has a good relationship with the drug registration department, and often clears the relationship through Liu Yuhui for drug registration approval, from which Liu Yuhui can profit, which is also a reason why Liu Yuhui gave him money. Another reason is that it helps pharmaceutical companies in Liu Yuhui to register and approve drugs. On the issue of his promotion, Liu Yuhui gave him money because it was more convenient for Liu Yuhui to handle affairs after he was promoted to deputy director.

From June, 5438 to October, 2000/kloc-0, the State Administration of Pharmaceutical Products issued the Regulations on Regulating the Management of Drug Packaging, Labeling and Instructions (Provisional) by Decree No.23, and decided to unify the packaging, labeling and instructions of drugs nationwide. 200 1 12 1, the implementation of the revised Drug Administration Law, in order to standardize the market, unify the standards and ensure the safety of drug use, canceled the local standards of drugs. Defendant Cao Wenzhuang, as the leader of an important functional department engaged in national drug supervision, knew that the special work involved the nationwide drug standard review, which was closely related to people's health, people's livelihood, social stability and government management ability, and it was a very important work. However, in March of 20001year, without in-depth investigation and study, Zheng Xiaoyu (sentenced), director of the State Administration of Pharmaceutical Products, was asked in the name of the Drug Registration Department, and hastily proposed to combine Executive Order No.23 with the unified renewal of drug approval number, and set a one-year time limit. With the consent of Zheng Xiaoyu, the Notice on Implementing No.23 Bureau Order and Unifying Drug Approval Number (hereinafter referred to as document 1 87) was issued with the document of State Drug Administration Note1,and special work was started nationwide, and the drug registration department headed by Cao Wenzhuang was entrusted.

Due to poor planning and poor organization in the early stage of the special work, Cao Wenzhuang instructed the members of the special working group to draft the Notice on Doing a Good Job in Uniform Renewal of Drug Approval Number on February 5438+0, 2006, which was signed and approved by Zheng Xiaoyu as National Medical Products Administration Note (200 1) No.582 (hereinafter referred to as No.582). The document has changed the content of "the special group will summarize and review the submitted materials" as stipulated in the 2004 document. 187 to "The relevant materials provided by enterprises when they declare can be copied, and the provincial drug supervision department will focus on reviewing their original production approval documents and original files, and the special team will conduct formal review of the submitted materials and conduct spot checks on the original files", lowering the auditing standards and weakening supervision, resulting in a large number of drugs that do not meet the national standards being approved.

In the later special work, Cao Wenzhuang did not perform his duties correctly and seriously, which violated the relevant regulations of the State Council, the Ministry of Health and the State Administration of Pharmaceutical Products. In March, 2003, he submitted the Request for Instructions on Doing a Good Job in the Unified Replacement of the Legacy Varieties with Drug Approval Number to Zheng Xiaoyu. For drugs illegally produced in places where the approval number should have been revoked, he hastily proposed that only on the basis of good manufacturing practices (hereinafter referred to as GMP) can the approval number of drugs illegally produced by local enterprises be updated. With the approval of Zheng Xiaoyu, most illegally produced drugs have been given approval numbers.

The above behavior of the defendant Cao Wenzhuang has seriously weakened the state's supervision over drugs, made the management and supervision of the drug market by the State Pharmaceutical Products Supervision and Administration a mere formality, and led to a large number of drugs whose registration numbers should not be changed or their approval numbers revoked, which provided an opportunity for fraud in drug production. In 2006, the State Food and Drug Administration of the United States conducted a spot check on a small number of pharmaceutical manufacturers, and found that a large number of approved drug numbers were obtained through counterfeiting, and the numbers were cancelled, and six drugs were confirmed as counterfeit drugs. In order to eliminate hidden dangers, the State Food and Drug Administration of the United States began to comprehensively clean up the drug approval number that has been renewed in September 2006, which consumed a lot of manpower and financial resources. Cao Wenzhuang's above-mentioned dereliction of duty led to the disorder of state drug management, increased the risk of drug use among the people, damaged the image of state organs in administration according to law, caused great losses to the interests of the state and the people, and caused bad social impact.