Beijing, XC District Food and Drug Administration.
On this day, several people in a hurry came to the door. The fat man leading the way was none other than Swansea, the president of Sanofi China.
He frowned and looked solemn, followed closely by several staff from the quality control department.
Generally speaking, when the Food and Drug Administration interviews pharmaceutical companies, it does not require the presence of the top person in charge. It only needs to send quality inspection personnel.
However, this time the notice from the Food and Drug Administration came very suddenly, with an extremely harsh tone, and was not communicated in advance. It seemed that the situation was very serious, so Swansea had to take action in person and participate in the interview.
He was afraid that an improper response would cause heavy losses to the company.
The company's current situation really cannot afford any blow.
The group of people was taken to an empty conference room and waited uneasily.
Soon, several staff members from the Drug Supervision and Administration Department walked in.
When Swansea saw the middle-aged man wearing glasses walking at the front for the first time, his heart suddenly thumped and he secretly screamed.
He has already recognized who the other person is. He is a powerful deputy director of the Food and Drug Administration, who is responsible for drug safety issues. He is very famous in the industry and is very difficult to deal with.
He had handled several serious safety incidents at domestic pharmaceutical companies in the past, and he had also been involved in the Johnson & Johnson recall scandal.
Usually when he comes forward for an interview, it shows that the problem is serious and the authorities take it very seriously.
This is no longer an ordinary recall incident that can be handled by a few General Administration staff.
Swansea put on a warm smile on his face, stepped forward quickly, stretched out his hand and said: "Li Bureau, thank you for meeting me. I am Swansea from Sanofi. Nice to meet you."
Li Junjie nodded expressionlessly, without speaking or extending his hand, and sat down directly opposite.
Swansea retracted his hand in embarrassment, touched his nose, and sat back.
He took out a stack of documents from his briefcase and handed it over.
"Hello, for these three irbesartan drugs sold in China, we have prepared sufficient supporting documents, including several qualified quality inspection reports, and the manufacturers are also different from those in other countries. This is enough It states that the drugs on sale do not have carcinogenic impurities, please take a look."
Director Li didn't make any move, but the staff member beside him took the document, flipped it over, and frowned.
"These are all your own internal documents, and they don't mean anything."
"Since something happened to your other factories, it means that you have problems with poor production conditions and lax management. Usually such serious product quality control disorders are not isolated. It is very likely that there are major hidden dangers in the manufacturing process and raw materials. In this way In other words, other factories are not safe either.”
"Besides, even if the production plants are different and the APIs and excipients used are the same, aren't there still risks? So reports like yours are really unconvincing."
"Do you have any other supporting documents? For example, third-party test reports? Summary of problematic drug batches? What is 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 questions, Swansea was speechless for a while.
He racked his brains to think of several excuses, considered his words, and was about to give an answer.
Director Li suddenly said: "Okay, put away all your excuses."
He waved his hand, and another staff member next to him took out a few thin pages of paper and placed them on the table.
"You may have misunderstood something. Our interview this time is not for you to defend, but to tell you a fact."
"This is the result of a random inspection of three irbesartan drugs by our testing center."
"You can look at the data. One of them does contain trace amounts of nitrosamines. I don't need to remind you. You should also understand that this is a strong carcinogen."
Swansea was stunned as if struck by thunder.
After a while, he picked up the test report and read it carefully.
As he watched, his hands began to tremble uncontrollably, shaking like fallen leaves in the wind, and he could hardly hold the thin pages.
He let the document slip from his fingertips, with a look of disbelief on his face, and murmured: "How could this happen?"
Nitrosamines are recognized as strong carcinogens. They attracted the attention of scientists in the 1960s. People first began to study it because experimental animals suffered liver failure after being fed fish meal with high sodium nitrite content.
Sodium nitrite combines with amines to form nitrosamines, and Sanofi's irbesartan contains n-nitrosodimethylamine, a strong carcinogen that can cause liver failure.
Liver failure is only one 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 and are not a problem with the raw materials.
As long as we strictly control the raw materials, make improvements in the production process, and strictly supervise, such problems can be completely avoided and are not considered particularly serious safety accidents.
However, patients who cannot tolerate antihypertensive drugs will have to take them for more than ten years, or even twenty or thirty years. The consequences of such long-term use, even if the content is extremely weak, are unpredictable.
N-nitrosamines are also present in cigarettes, and smoking is one of the important causative factors of lung cancer.
Of course, the dosage of antihypertensive drugs is not that high. There are many carcinogens in cigarettes, not just n-nitrosamines.
However, there are great differences in physical constitution between people. Some people can get lung cancer even if they smoke secondhand smoke, and some old smokers can live healthy and healthy until they are 90 years old. When it comes to cancer cell mutations, it is often difficult to tell the probability.
Therefore, the most reliable and safest measure is to completely eliminate such dangerous carcinogens.
Swansea are completely speechless now.
He lowered his head and said with a very sincere attitude: "This is indeed our mistake, but I have to report this to the headquarters first before..."
Director Li immediately interrupted him: "You have only one choice now."
"Either recall immediately, or your company's drugs will be directly banned from sale in China."
"Choose one of the two, you pick one."
His voice was extremely cold, as if a superior judge was making the final judgment on Sanofi's crimes.
Cold sweat broke out on Swansea's forehead instantly. He knew that the lake really couldn't be crossed now, and delaying tactics couldn't be used.
If the recall of problematic drugs will bring huge losses to the company, then being banned from sale will be a burden that the company cannot bear.
I could only grit my teeth and agree.
He immediately nodded like a chicken pecking at rice and agreed.
"Okay, okay, we will immediately recall all the problematic drugs, make a sincere apology, and compensate the patients who suffered losses."
Director Li finally showed a rare smile at this moment and nodded, seeming to be satisfied with his knowledge.
Now that the result has been obtained, the interview ended quickly.
Swansea walked out of the Food and Drug Administration building in despair, followed by a group of subordinates who came just for fun.
A flash of intense regret flashed through his heart.
If I had known this would happen, I should have taken the initiative to recall it when something went wrong, and maybe I would have gained a good reputation as someone who corrected my mistakes after they were aware of them.
Now not only do they have to be notified and criticized by the Food and Drug Administration, but the carcinogenic problem of antihypertensive drugs has also been thoroughly implemented.
After all, voluntary recall can be said to be prepared for danger in times of peace, to take drug safety issues seriously, to be responsible for patients, and to treat everyone equally.
It is another matter to be issued a notice by the Food and Drug Administration and ordered to be recalled.
Regardless of whether there are problems or not, the reputation of these three antihypertensive drugs is completely bad.
The lost market can never be recovered.
And Sanofi, a company, will be completely nailed to the pillar of shame like the Bangguo Two-Star Group.
