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Beijing, General Administration of Food and Drug Administration of XC District.

On this day, a few people came in a hurry at the door, and the leading fat man was Swansea, the president of Sanofi China.

He frowned, with a dignified expression, followed by several quality control staff.

Generally speaking, when the Food and Drug Administration interviews pharmaceutical companies, it does not require the presence of a top person in charge like him, as long as it sends quality inspectors.

However, this time the announcement from the Food and Drug Administration came very suddenly, the tone was extremely severe, and there was no communication in advance. It seemed that the situation was very serious, so Swansea had to go out and participate in the interview.

He was afraid that a wrong response would cause heavy losses to the company.

The current situation of the company really can't afford any blow.

A group of people were taken to an empty conference room and waited anxiously.

Soon, several staff members from the Drug Administration came in.

When Swansea saw the middle-aged man wearing glasses walking in front for the first time, his heart skipped a beat and he cried out inwardly.

He has already recognized who the other party is. This is a powerful deputy director of the Food and Drug Administration, who is in charge of drug safety issues. He is well-known in the industry and is very difficult to deal with.

He was responsible for several serious safety incidents in domestic pharmaceutical companies before, and he also interviewed Johnson \u0026 Johnson's 'recall' incident.

Generally speaking, the interview with him shows that the problem is serious, and the authorities attach great importance to it.

This is no longer an ordinary recall that can be handled by a few staff members of the General Administration.

Swansea forced a warm smile on his face, stepped forward quickly, stretched out his hand and said, "Ju Li, it's a pleasure to meet you, I'm Swansea from Sanofi, nice to meet you."

Li Bing nodded expressionlessly, did not speak, did not extend his hand, and sat down directly opposite.

Swansea withdrew his hand in embarrassment, touched his nose, and sat back.

He pulled a stack of papers from his briefcase and handed them over.

"Hello, we have prepared sufficient supporting documents for these three irbesartan drugs sold in China, including several qualified quality inspection reports, and the manufacturers are different from those in other countries, which is enough It shows that there are no carcinogenic impurities in the drugs on sale, please take a look."

Director Li didn't do anything, the staff beside him took the document, flipped through it, and frowned.

"These are all your own internal documents, and they don't explain anything."

"Since something happened to your other factories, it means that you have poor production conditions and loose management. Usually such serious product quality control abnormalities are not isolated. It is likely that there are major hidden dangers in the manufacturing process and raw materials. In this way, other factories are not safe either."

"Besides, even if the production plants are different, and the raw materials and excipients used are the same, isn't that still risky? So your report is really not convincing."

"Do you have any other supporting documents? Such as third-party testing reports? Summary of drug batches with problems? The impact of carcinogenic impurities in the drug on the efficacy of the drug, and the possible consequences for patients?"

Faced with this series of pressing questions, Swansea was momentarily speechless.

He racked his brains to think of several excuses, considered his language, and was about to answer.

Li Ju suddenly said: "Okay, put away all your excuses."

With a wave of his hand, another staff member next to him took out a few thin pages and put them on the table.

"You may have misunderstood something. Our interview is not for you to defend, but to tell you a fact."

"This is the result of our testing center's random inspection of three irbesartan drugs."

"You can look at the data. One of them does contain a small amount of nitrosamines. I don't need to remind you. You should also understand that this is a strong carcinogen."

Swansea froze instantly as if struck by lightning.

After a while, he picked up the test report and read it carefully.

Looking at it, his hands began to tremble uncontrollably, shaking like fallen leaves in the wind, and he could hardly hold these thin sheets of paper.

He let the document slip from his fingertips, with a look of disbelief on his face, he murmured, "How could this be?"

Nitrosamines are recognized as strong carcinogens. They first attracted the attention of scientists in the 1960s. People began to study them because of liver failure in experimental animals fed fish meal with high levels of sodium nitrite.

Sodium nitrite combines with amines to form nitrosamines, and Sanofi's irbesartan contains N-nitrosodimethylamine, a strong carcinogen that causes liver failure.

Liver failure is only a manifestation of its toxicity, and more often it causes other diseases such as lung cancer.

Generally speaking, the content of carcinogenic impurities in antihypertensive drugs is very low, and most of them come from excipients, not the problem of raw materials.

As long as the raw materials are strictly controlled, and improvements are made in the production process and strict supervision, such problems can be completely avoided, and it is not a particularly bad safety accident.

However, patients who cannot stand antihypertensive drugs have to take them for more than ten years, or even twenty or thirty years. Such long-term use, even if the content is extremely weak, the consequences are unpredictable.

N-nitrosoamines also exist in cigarettes, and smoking is one of the important pathogenic factors of lung cancer.

Of course, the dose of antihypertensive drugs is not so high, and there are many carcinogens in cigarettes, not only N-nitrosoamines.

But there are great differences in physique between people. Some people who smoke secondhand smoke can get lung cancer, and some old smokers can live healthy and healthy until they are 90 years old. It is really hard to say the probability of cancer cell mutations.

Therefore, it is the safest and safest measure to completely eliminate such a dangerous carcinogen.

Swansea has nothing to say now.

He lowered his head and said sincerely: "This is indeed our mistake, but I have to report this to the headquarters first before..."

Director Li immediately interrupted him: "You only have one choice now."

"Either recall it immediately, or your company's drugs are directly banned in China."

"Choose one, you pick one."

His voice was extremely cold, as if a high-ranking judge was making the final verdict on Sanofi's crimes.

Cold sweat broke out on Swansea's forehead in an instant. He knew that this time he really couldn't be fooled, and there was no way to delay the attack.

If the recall of problematic drugs will bring huge losses to the company, then being banned is a burden that the company cannot afford.

He could only grit his teeth and agree.

He immediately nodded like a chicken pecking at rice, and responded with a gulp.

"Okay, okay, we will immediately recall all the problematic drugs, make a sincere apology, and make compensation to the patients who suffered losses."

Li Ju finally showed a rare smile on his face at this moment, and nodded, as if he was satisfied with his knowledge.

Now that the results have been reached, the interview ended very quickly.

Swansea walked out of the Food and Drug Administration building in a daze, followed by a group of subordinates who came here purely to make soy sauce.

A flash of intense regret flashed through him.

If I had known this would happen, I should have taken the initiative to recall it when something happened, and maybe I could get a good reputation for correcting it when I knew it was wrong.

Now not only will it be criticized by the Food and Drug Administration, but the carcinogenic problem of antihypertensive drugs has also been thoroughly implemented.

After all, voluntary recall can also be said to be prepared for danger in times of peace. It takes drug safety issues seriously, is serious and responsible for patients, and treats them equally.

It is another matter to be notified by the Food and Drug Administration to order a compulsory recall.

Regardless of whether there is a problem or not, the reputation of these three antihypertensive drugs is completely stinky.

The lost market can never be regained.

And Sanofi, a company, will be completely nailed to the pillar of shame like the Bangguo Two-Star Group.