Smith said very seriously, “Mr. Wei, our Western requirements for testing as well as reviewing drugs are very different from traditional Eastern medicine, and one of the very important points is that there must be a clear pharmacokinetic test.”
“You must tell us clearly what is the active ingredient of this drug, for what reason, what kind of effect it plays, and you must also tell us whether this drug has toxic side effects in the body, in various organs, especially the liver and kidneys,”
“And how long is the metabolic cycle of its ingredients in the body, if these are not clear, there is no way we can allow it to enter our market sales.”
Liang said, “In many Chinese medicines, the composition of their prescriptions are very complex, so the internal composition is also very complex, unlike Western medicines which are mostly chemical drugs,”
“The active ingredient is often only one, such as penicillin, aspirin, a molecular formula can reflect its actual composition and formation, all the Chinese medicines are difficult to meet the requirements of the West, but this should not seek common ground while preserving differences?”
Smith shook his head and said, “Sorry Mr. Wei, this is something we cannot do to seek common ground while preserving differences, the rules are the rules, all drugs to enter the U.S. market, in principle, must meet all our rules, otherwise they cannot be marketed and sold.”
Liang was busy saying, “Our drug is extremely effective, which is recognized by all patients, and is a best-selling drug in many countries, as far as I know, many American patients are buying our JX Stomach powder by way of proxy,”
“But this method not only takes a long time, but also costs much more, and they all hope that the FDA will allow it to enter the U.S. market as soon as possible. “
Smith shook his head and said, “Many patients themselves can not tell whether your drug has a clear therapeutic effect or a strong effect of surface symptom relief,”
“If the former is okay, but if the latter, it is likely to also delay the treatment of the actual lesion.”
Speaking of which, Smith added: “It’s like there is a very hot selling hemorrhoid suppository drug from China, some patients in the United States through online shopping, as well as black market channels, buy these drugs,”
“Use them down also feel very good, and it has also been hoping to pass the FDA review, but we have not been through its application, you know why?”
Liang asked in disbelief: “Then why exactly?”
Smith said: “Because in our opinion, that kind of hemorrhoid suppositories, the use of some cool analgesic ingredients, this kind of ingredients can let patients relieve pain,”
“But it just can relieve pain, in our opinion, these ingredients not only can not really treat the lesion, but also probably will therefore cover up the disease, thus delaying the scientific treatment of patients,”
“So, we also issued a warning some time ago, reminding patients using this drug to pay attention to screening and not to ignore the core problem because of the relief of surface symptoms.”
“In addition to that, we have also studied that something combined with tablets that used to sell very hot in China, which is said to be a special cold medicine made with honeysuckle and forsythia with some western medicine ingredients.”
“But after our research, we found that in that kind of drug, what really plays a therapeutic role are two western ingredients, one is a common drug to reduce fever and analgesia, acetaminophen;”
“And another is a drug specifically used to relieve allergies, rhinitis, and symptoms such as sneezing and runny nose, paracetamol, the two of them combined, just to treat fever and cold and runny nose.”
Speaking here, Smith spread his hands, serious and with a few helpless expressions, “Mr. Wei, I am also not deliberately against you, or against the entire Eastern traditional medicine.”
“But think about it, if you, JX Pharmaceutical, also casually use some plant ingredients, and then with the Western medicine ingredient metformin that can control blood sugar,”
“And then just claim to the public that this is a kind of Chinese medicine that can effectively lower blood sugar, then do you think we are likely to approve this kind of drug to market?”
“This is why, we have been very, very cautious about Oriental drugs, medicine is a very rigorous discipline, must be clear, clear to be, can not be irresponsible recklessly pieced together.”
Liang also felt a little embarrassed, said stiffly: “Mr. Smith, I do not deny what you just said these things, there are a few so-called Chinese medicines, or the combination of East and West,”
“There are indeed suspicions of hanging sheep’s head to sell dog meat, but I think, you can not be all rejecting because there have been such cases, all the Eastern traditional medicine drugs are beaten to death, there are still many, many excellent drugs.”
Smith nodded: “I certainly do not deny this point, but I want to say that even excellent traditional Oriental medicine drugs must meet all our FDA requirements before they can enter our market,”
“So if your drug wants to enter the U.S. market for sale, you must let us first understand all its ingredients, as well as the use of each ingredient with potential dangers.”
Liang asked rhetorically, “Then if, as you just said, the ingredients of many proprietary Chinese medicines are so complex that they may not even be explained by a few ingredients, or even to dozens or hundreds, how can we determine them one by one?”
Smith shrugged: “If it can not be determined one by one, then we have to no way to pass.”
Liang asked again, “Even if you know that this drug is very effective, but just because you can’t fully determine the ingredients as well as the effects, you refuse to market it?”
“Yes.” Smith said categorically, “Our attitude is this, even if this drug is really effective, but before we do not figure it out absolutely, it can not be marketed.”
Liang couldn’t help but ask: “Then don’t you think, this is also the loss for the American people?”
“Loss?” Smith heard this and said with more or less a contemptuous tone, “Mr. Wei, to be honest, for all the Eastern drugs I know of so far, we have plenty of alternatives in the U.S., and safer, more efficient alternatives at that!”
“Whether it’s about headache, brain fever, or about all organs, blood vessels and the nervous system, including the heart, liver, spleen, lungs, and kidneys, what you have in Eastern traditional medicine, we have in Western medicine, and the Western treatment methods are much better than the Eastern treatment methods!
