Plane Merchant's Dream of a Powerful Country
Chapter 292 The U.S. FDA with Two Dilemmas
ps: Thank you readers for the lighter that "Zizhu" gave to heaven, thank you ^_^
At the beginning of January 14, the price increase of some civilian necessities occurred in major supermarket chains in the Republic of Stars and Stripes, which did not immediately attract the attention and attention of the price department of the Stars and Stripes Government.Since the price increases are all small commodities, and the types are only part of the range, it is necessary to wait until the regular domestic price statistics of Stars and Stripes to see the relative increase.But that should be a few months away.
Although the price issue has not attracted much attention, it does not mean that the Stars and Stripes government has nothing to do.In addition to spending a lot of energy on the affairs of the continents of the world, the Obama administration also makes regular reports from relevant domestic agencies, which is also one of the priorities of the Obama administration.At this time, one copy of _ion), referred to as FDA.It is one of the executive agencies established by the Stars and Stripes government in the Department of Health and Human Services (dhhs) and the Department of Public Health (phs). It is authorized by the Stars and Stripes Congress, the federal government, to specialize in food and drug management.From the perspective of authority and influence, it is the most authoritative and influential international medical audit organization in the world. As long as the pharmaceuticals and food of various companies in the world pass the audit of the Stars and Stripes fda, its products can basically be sold anywhere in the world. A country (except for countries like North Korea ^_^).
The fda itself is made up of professionals such as doctors, lawyers, microbiologists, pharmacologists, chemists and statisticians.In other words, it is not like the Yanhuang Food and Drug Administration, which is dominated by officials and has a very obvious and serious influence of personal preferences.If you want to pass the FDA's drug-grade certification, it is just a general drug, which requires a trial period of up to 7 years. Twenty or thirty people are tested every day. After only 7 years, these people have not found any physical side effects after inspection. Only then will the drug be allowed to pass the certification and be marketed.And because these people are not helping the company to test products for free, after 7 years, the company has spent a lot of time and financial resources, which is why the FDA is one of the most difficult drug inspections in the world.
Originally, this kind of agency would not pose any problems for Obama, because after decades of effective operation, the fda has a relatively rigorous and scientific review process.But today, it is because of the contradictions within the fda itself, and the opinions are not unified, which led to the report to the Obama administration.As for the cause, it's also very simple, that is Yanhuang's new drugs that are currently undergoing clinical trials - Hua'ai Pill and Kang'ai Pill.
Because the Yanhuang government did not invite countries around the world and health organizations to participate in the clinical trials of these two new drugs.Therefore, from an official point of view, these two new drugs should only exist in Yanhuang's domestic medicine and serve the people of Yanhuang in the country.However, since the new drug launch event is open to the whole world, many terminal cancer patients in Europe and the Stars and Stripes, who have to bear the cost of flight tickets, rushed to Yanhuang on their own with a one-ten-thousandth hope and the mentality of being a dead horse as a living doctor. Several designated experimental tumor hospitals applied for human trials of the Caucasian version and the black version (the Stars and Stripes has black citizens) of these two new drugs, based on humanitarian requirements and as volunteers.
Considering the international influence involved, the directors of several hospitals did not dare to make decisions without authorization, so they had to report to the provincial and municipal health bureaus level by level, and finally the provinces even submitted the reports to the Yanhuang State Council.After a brief discussion between Chief No. [-] and Prime Minister Song, considering the need to clarify the efficacy of the drug, and to "extravagantly ask for prices" in the future, they finally agreed and sent planes to airlift a small amount of the black and white versions of the cancer Dan and anti-ai pills.
With the passage of treatment time, the conditions of foreign cancer and AIDS patients are getting better and better, and the cancer cells and AIDS virus are not only initially suppressed, but also gradually decrease.Let the cancer and AIDS terminal patients who came for treatment see the dawn of recovery.After the reporter sent by CNN made a special report on this magical effect, it caused a sensation in the Stars and Stripes.Many cancer and AIDS patients across the Stars and Stripes marched to demand that the government quickly introduce these two new drugs and include them in the medical insurance list.
"Your Excellency, according to the report of the FDA, their views are now divided into two factions, and they are relatively opposed." Vice President Cheney mainly helped Obama share many complicated affairs in the country. He introduced: "The doctors, microbiologists and pharmacologists of the FDA Scientists proposed that this kind of special drug that can treat terminal illnesses should be introduced in small batches as soon as the first batch of clinical results of Yanhuang came out, and be used to treat cancer and advanced AIDS patients with few lives in China; but the rest of the lawyers, Statisticians still insist on the 7-year clinical trial period, and they insist that the new drug can only be officially released in China after it is confirmed that it is really effective and has no toxic or side effects.”
"I heard that the fda is arguing intensely right now?" Although Secretary of State Hillary is in charge of diplomacy, she also interjected at this time.
"Indeed, since the average life expectancy of advanced cancer patients is only 3 months to 1 years, the wishes of the FDA doctor group are very clear, and 7 years is enough for many patients to wait until the end of the clinical trial. And lawyers and jurists The point of view is to stick to the principle, and they propose that if this case is opened, other drugs will use the same reason to shorten the experimental cycle in the future, which will bring irreversible impact and threat to the domestic pharmaceutical market and the lives of patients.” Cheney replied .
"Cough! From my own point of view, I am very inclined to introduce these two new drugs as soon as possible." Obama, who has spent many years of thinking and energy, and his temples have been mottled and gray, puts his hands together and rubs his hands. AIDS rampant phenomenon caused by drug abuse, sex, etc., replied.
"But lawyers have the rules in their hands. Due to legal restrictions, we cannot directly make them obey the administrative orders issued by our government." Cheney reminded, "In addition, I would like to remind everyone that due to the restrictions on the new drugs announced by Yanhuang earlier The output ratio is 100:10:1 for the yellow version, the black version, and the white version, so we will have many competitors in the future. It is reported that many European countries have begun to contact Yanhuang in private, hoping to be able to The first batch of new medicines will be supplied."
"I always thought that this ratio was deliberately created by the Yanhuang people, but it doesn't exist at all." Hilary shook her head.
"Maybe what you said is the truth. But now the Yanhuang people have mastered all the production techniques and formulas of the new drug, and they have all the good cards in their hands." Cheney said with a wry smile.
"Is it possible for our eyeliner inside Yanhuang to obtain new drug formulas or chemical formulas?" Hilary asked persistently.
"It's hard! Since Yanhuang launched the largest anti-corruption campaign last year, the loss rate of the chess pieces we arranged in Yanhuang exceeded 95%, and the rest are some low-ranking, insignificant little people."
"I remember that some of the richest people in the country, past and present, were all infected with AIDS or cancer for some reason. If we start with them to mobilize the media to exert influence and resonate with the public, what do you think?" Obama interjected.
"President, what do you mean?"
"Jobs! He passed away early due to cancer. If there is a special cancer drug, Jobs can live for at least 20 years. Apple will still maintain the aura of a magical company and continue to create great products, instead of constantly copying old products. At the level of a first-class company. I think we can mobilize some media to report more articles in this regard, and disclose the plight of some cancer and AIDS patients, and use the pressure of public opinion to force the lawyers to make concessions."
"The wife of Boehner (the Speaker of the House of Representatives of the Stars and Stripes) has breast cancer in the early stage. Although he is very calm and strong, I am sure that he will be on our side." Hillary nodded in agreement.
"Then the remaining problem is the domestic pharmaceutical companies. Behind the legal group, they are actually blocking new drugs. The starting point is to ensure the market and profits of existing domestic anti-cancer drugs to the greatest extent possible. Of course, it needs to be explained that they are also our campaign funds. One of the important providers." Cheney woke up.
"A bunch of dirty parasites." Obama muttered in a very low voice, and then said: "We don't need to be completely at the mercy of them, otherwise we will lose a lot in the next governor elections in various states. Let's proceed as we just said! "
"Yes, Your Excellency the President!"
The next day, 14/1/7.
The "New York Times", the Stars and Stripes newspaper with the greatest influence in China, has the reputation of "Records and Records". or principle), the article cites a large number of cases, counts the helplessness and despair of celebrities or ordinary citizens in the past Stars and Stripes at the last moment of life, and highlights the great significance and contribution of Hua'ai Pill and Anti-Ai Pill to human beings, so as to arouse people's attention. resonance.Naturally, Jones John Winston concluded by writing that if Jobs hadn't died, Apple's miracle would have lasted another 20 years, leading to enormous domestic economic growth and a sufficiently attractive number of domestic jobs Opportunity, the development of the Star-Spangled Banner Republic, needs more Jobs.
"Washington Post", as the second largest newspaper in the Stars and Stripes, took full advantage of the fact that its reporters, editors and political circles are very familiar with it, and obtained documents related to fda meeting materials from within, and bombarded fda's internal lawyer group by breaking the "insider" The bureaucratic style and the inhuman behavior that disregarded life caused an uproar in the public opinion for a while.
The "Wall Street Journal" is relatively more interesting. This is a serious newspaper that basically has no pictures or colors, and must have charts.It spends an entire page detailing the current situation and future prospects of major medical companies in the New York Stock Exchange, as well as the impact of Huaai Pill and Kangai Pill on their performance, and also used it to predict the New York Dow Jones pharmaceutical sector in 14. trend.
......
Yanhuang Continent, Xingshang Diamond Hill Community, Jinhai City.
"Yardi, it's almost done. The rumors inside the Stars and Stripes have nothing to do with us. We just need to wait for the news. Is it time to start a domestic agricultural plan?" Wang Fan looked at the news on CNN about new drugs The various schools debated and smiled proudly.
"No problem. I have already produced and stored agricultural materials, and they can be put on the market in large quantities at any time." Yadi replied.
"Haha, that's great, then let's start the 'Rural Campaign' tomorrow!"
At the beginning of January 14, the price increase of some civilian necessities occurred in major supermarket chains in the Republic of Stars and Stripes, which did not immediately attract the attention and attention of the price department of the Stars and Stripes Government.Since the price increases are all small commodities, and the types are only part of the range, it is necessary to wait until the regular domestic price statistics of Stars and Stripes to see the relative increase.But that should be a few months away.
Although the price issue has not attracted much attention, it does not mean that the Stars and Stripes government has nothing to do.In addition to spending a lot of energy on the affairs of the continents of the world, the Obama administration also makes regular reports from relevant domestic agencies, which is also one of the priorities of the Obama administration.At this time, one copy of _ion), referred to as FDA.It is one of the executive agencies established by the Stars and Stripes government in the Department of Health and Human Services (dhhs) and the Department of Public Health (phs). It is authorized by the Stars and Stripes Congress, the federal government, to specialize in food and drug management.From the perspective of authority and influence, it is the most authoritative and influential international medical audit organization in the world. As long as the pharmaceuticals and food of various companies in the world pass the audit of the Stars and Stripes fda, its products can basically be sold anywhere in the world. A country (except for countries like North Korea ^_^).
The fda itself is made up of professionals such as doctors, lawyers, microbiologists, pharmacologists, chemists and statisticians.In other words, it is not like the Yanhuang Food and Drug Administration, which is dominated by officials and has a very obvious and serious influence of personal preferences.If you want to pass the FDA's drug-grade certification, it is just a general drug, which requires a trial period of up to 7 years. Twenty or thirty people are tested every day. After only 7 years, these people have not found any physical side effects after inspection. Only then will the drug be allowed to pass the certification and be marketed.And because these people are not helping the company to test products for free, after 7 years, the company has spent a lot of time and financial resources, which is why the FDA is one of the most difficult drug inspections in the world.
Originally, this kind of agency would not pose any problems for Obama, because after decades of effective operation, the fda has a relatively rigorous and scientific review process.But today, it is because of the contradictions within the fda itself, and the opinions are not unified, which led to the report to the Obama administration.As for the cause, it's also very simple, that is Yanhuang's new drugs that are currently undergoing clinical trials - Hua'ai Pill and Kang'ai Pill.
Because the Yanhuang government did not invite countries around the world and health organizations to participate in the clinical trials of these two new drugs.Therefore, from an official point of view, these two new drugs should only exist in Yanhuang's domestic medicine and serve the people of Yanhuang in the country.However, since the new drug launch event is open to the whole world, many terminal cancer patients in Europe and the Stars and Stripes, who have to bear the cost of flight tickets, rushed to Yanhuang on their own with a one-ten-thousandth hope and the mentality of being a dead horse as a living doctor. Several designated experimental tumor hospitals applied for human trials of the Caucasian version and the black version (the Stars and Stripes has black citizens) of these two new drugs, based on humanitarian requirements and as volunteers.
Considering the international influence involved, the directors of several hospitals did not dare to make decisions without authorization, so they had to report to the provincial and municipal health bureaus level by level, and finally the provinces even submitted the reports to the Yanhuang State Council.After a brief discussion between Chief No. [-] and Prime Minister Song, considering the need to clarify the efficacy of the drug, and to "extravagantly ask for prices" in the future, they finally agreed and sent planes to airlift a small amount of the black and white versions of the cancer Dan and anti-ai pills.
With the passage of treatment time, the conditions of foreign cancer and AIDS patients are getting better and better, and the cancer cells and AIDS virus are not only initially suppressed, but also gradually decrease.Let the cancer and AIDS terminal patients who came for treatment see the dawn of recovery.After the reporter sent by CNN made a special report on this magical effect, it caused a sensation in the Stars and Stripes.Many cancer and AIDS patients across the Stars and Stripes marched to demand that the government quickly introduce these two new drugs and include them in the medical insurance list.
"Your Excellency, according to the report of the FDA, their views are now divided into two factions, and they are relatively opposed." Vice President Cheney mainly helped Obama share many complicated affairs in the country. He introduced: "The doctors, microbiologists and pharmacologists of the FDA Scientists proposed that this kind of special drug that can treat terminal illnesses should be introduced in small batches as soon as the first batch of clinical results of Yanhuang came out, and be used to treat cancer and advanced AIDS patients with few lives in China; but the rest of the lawyers, Statisticians still insist on the 7-year clinical trial period, and they insist that the new drug can only be officially released in China after it is confirmed that it is really effective and has no toxic or side effects.”
"I heard that the fda is arguing intensely right now?" Although Secretary of State Hillary is in charge of diplomacy, she also interjected at this time.
"Indeed, since the average life expectancy of advanced cancer patients is only 3 months to 1 years, the wishes of the FDA doctor group are very clear, and 7 years is enough for many patients to wait until the end of the clinical trial. And lawyers and jurists The point of view is to stick to the principle, and they propose that if this case is opened, other drugs will use the same reason to shorten the experimental cycle in the future, which will bring irreversible impact and threat to the domestic pharmaceutical market and the lives of patients.” Cheney replied .
"Cough! From my own point of view, I am very inclined to introduce these two new drugs as soon as possible." Obama, who has spent many years of thinking and energy, and his temples have been mottled and gray, puts his hands together and rubs his hands. AIDS rampant phenomenon caused by drug abuse, sex, etc., replied.
"But lawyers have the rules in their hands. Due to legal restrictions, we cannot directly make them obey the administrative orders issued by our government." Cheney reminded, "In addition, I would like to remind everyone that due to the restrictions on the new drugs announced by Yanhuang earlier The output ratio is 100:10:1 for the yellow version, the black version, and the white version, so we will have many competitors in the future. It is reported that many European countries have begun to contact Yanhuang in private, hoping to be able to The first batch of new medicines will be supplied."
"I always thought that this ratio was deliberately created by the Yanhuang people, but it doesn't exist at all." Hilary shook her head.
"Maybe what you said is the truth. But now the Yanhuang people have mastered all the production techniques and formulas of the new drug, and they have all the good cards in their hands." Cheney said with a wry smile.
"Is it possible for our eyeliner inside Yanhuang to obtain new drug formulas or chemical formulas?" Hilary asked persistently.
"It's hard! Since Yanhuang launched the largest anti-corruption campaign last year, the loss rate of the chess pieces we arranged in Yanhuang exceeded 95%, and the rest are some low-ranking, insignificant little people."
"I remember that some of the richest people in the country, past and present, were all infected with AIDS or cancer for some reason. If we start with them to mobilize the media to exert influence and resonate with the public, what do you think?" Obama interjected.
"President, what do you mean?"
"Jobs! He passed away early due to cancer. If there is a special cancer drug, Jobs can live for at least 20 years. Apple will still maintain the aura of a magical company and continue to create great products, instead of constantly copying old products. At the level of a first-class company. I think we can mobilize some media to report more articles in this regard, and disclose the plight of some cancer and AIDS patients, and use the pressure of public opinion to force the lawyers to make concessions."
"The wife of Boehner (the Speaker of the House of Representatives of the Stars and Stripes) has breast cancer in the early stage. Although he is very calm and strong, I am sure that he will be on our side." Hillary nodded in agreement.
"Then the remaining problem is the domestic pharmaceutical companies. Behind the legal group, they are actually blocking new drugs. The starting point is to ensure the market and profits of existing domestic anti-cancer drugs to the greatest extent possible. Of course, it needs to be explained that they are also our campaign funds. One of the important providers." Cheney woke up.
"A bunch of dirty parasites." Obama muttered in a very low voice, and then said: "We don't need to be completely at the mercy of them, otherwise we will lose a lot in the next governor elections in various states. Let's proceed as we just said! "
"Yes, Your Excellency the President!"
The next day, 14/1/7.
The "New York Times", the Stars and Stripes newspaper with the greatest influence in China, has the reputation of "Records and Records". or principle), the article cites a large number of cases, counts the helplessness and despair of celebrities or ordinary citizens in the past Stars and Stripes at the last moment of life, and highlights the great significance and contribution of Hua'ai Pill and Anti-Ai Pill to human beings, so as to arouse people's attention. resonance.Naturally, Jones John Winston concluded by writing that if Jobs hadn't died, Apple's miracle would have lasted another 20 years, leading to enormous domestic economic growth and a sufficiently attractive number of domestic jobs Opportunity, the development of the Star-Spangled Banner Republic, needs more Jobs.
"Washington Post", as the second largest newspaper in the Stars and Stripes, took full advantage of the fact that its reporters, editors and political circles are very familiar with it, and obtained documents related to fda meeting materials from within, and bombarded fda's internal lawyer group by breaking the "insider" The bureaucratic style and the inhuman behavior that disregarded life caused an uproar in the public opinion for a while.
The "Wall Street Journal" is relatively more interesting. This is a serious newspaper that basically has no pictures or colors, and must have charts.It spends an entire page detailing the current situation and future prospects of major medical companies in the New York Stock Exchange, as well as the impact of Huaai Pill and Kangai Pill on their performance, and also used it to predict the New York Dow Jones pharmaceutical sector in 14. trend.
......
Yanhuang Continent, Xingshang Diamond Hill Community, Jinhai City.
"Yardi, it's almost done. The rumors inside the Stars and Stripes have nothing to do with us. We just need to wait for the news. Is it time to start a domestic agricultural plan?" Wang Fan looked at the news on CNN about new drugs The various schools debated and smiled proudly.
"No problem. I have already produced and stored agricultural materials, and they can be put on the market in large quantities at any time." Yadi replied.
"Haha, that's great, then let's start the 'Rural Campaign' tomorrow!"
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