Chapter 292: The US FDA in a dilemma

ps: Thank you readers for the lighter that the big "Zizhu" gave to heaven, thank you ^_^

At the beginning of January 2014, the price increase of some civilian necessities occurred in the 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 price statistics of the Stars and Stripes in China to see the relative increase. But that should have been a few months later.

Although the price of goods has not attracted attention, it does not mean that the Stars and Stripes government has nothing to do. In addition to spending a great deal of energy on all continents, the Obama administration's regular reports from relevant agencies in the country are also one of the priorities of the Obama administration. At this point, an F.D.A. report was causing them a headache.

The Stars and Stripes Food and Drug Administration (food_and_drug_adiministration), abbreviated as FDA. It is one of the executive agencies established by the Stars and Stripes Government within the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS), and it is authorized by the Stars and Stripes Congress, the federal government's highest law enforcement agency, to specialize in food and drug administration. In terms of authority and influence, it is the world's most authoritative and influential international medical audit body, and the drugs and food of various companies in the world can be sold to basically any country in the world (except for ^_^ countries like North Korea) as long as they pass the audit of the Stars and Stripes FDA.

The FDA itself is made up of professionals such as doctors, lawyers, microbiologists, pharmacologists, chemists and statisticians. In other words, it is not a collection of officials-led and very obvious and serious personal preferences like the Yanhuang Food and Drug Administration. If you want to pass the FDA's drug-grade certification, just a general drug, you have to go through a trial period of up to 7 years, try it on 20 or 30 people every day, and only after 7 years, these people do not find any physical side effects after examination, and the drug will be allowed to pass the certification and go on sale. And because these people are not free to help companies test products, so in the past 7 years, companies have spent a lot of time and financial resources, which is why the FDA is one of the most difficult drug tests in the world.

Originally, such an institution would not normally give Obama any problems, because after decades of effective operation, the FDA has a relatively rigorous and scientific internal review process. However, today it is because of the contradictions and disagreements within the FDA that it will be reported to the Obama administration. As for the cause, it is also very simple, that is, Yan Huang's new drugs that are in clinical trials - Cancer Pill and Anti-Moxa 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 domestic medicine and serve the people of Yanhuang in their own country. However, because the launch of the new drug is open to the whole world, many terminally ill cancer patients in Europe and Stars and Stripes who bear the cost of flight tickets have rushed to several designated experimental cancer hospitals in Yanhuang at their own discretion to apply for human trials of the Caucasian version and the black version of the two new drugs (the Stars and Stripes have black citizens) as humanitarian requests and volunteers.

Considering the international implications, the directors of several hospitals did not dare to make decisions on their own, so they had to report to the provincial and municipal health bureaus one by one, and finally the provinces even submitted the reports to the Yanhuang State Council. After a brief discussion between Chief No. 1 and Premier Song, considering the need to clarify the efficacy of the drug, so as to carry out the "sky-high price" in the future, he finally agreed, and sent planes to airlift a small number of black and white versions of cancer pills and anti-moxa pills to various hospitals.

With the passage of treatment, the condition of cancer and AIDS patients abroad is getting better day by day, and cancer cells and HIV are not only initially suppressed, but also gradually decreasing. It has allowed patients with advanced cancer and AIDS who come for treatment to see the dawn of recovery. This miraculous effect caused a sensation in the country after the reporter sent by N made a special report. Many cancer and AIDS patients in the Stars and Stripes countries marched to demand that the government quickly introduce the two new drugs and include them in the Medicare list.

"Your Excellency the President, according to the FDA report, there are now two factions of opinion, and they are relatively opposed." Vice President Cheney mainly helped Obama share many complicated domestic affairs, he said: "FDA doctors, microbiologists and pharmacologists have proposed that this special drug that can treat terminal diseases, after the first batch of clinical results of Yanhuang is released, will be introduced in small batches to treat cancer and AIDS patients in China, who have few lives; However, the rest of the lawyers and statisticians still insisted on the seven-year clinical trial period, and they insisted that only after confirming that the new drug is indeed true and effective and has no toxic side effects can it be officially sold in China. ”

"I heard that there is a lot of noise within the FDA right now?" Secretary of State Hillary Clinton, who is in charge of foreign affairs, also interjected at this time.

"Indeed, since the average life expectancy of patients with advanced cancer is only three months to one and a half years, the willingness of the FDA physician community is very clear, and seven years is enough time for many patients to wait for the end of clinical trials. The view of lawyer jurists adheres to the principle, and they propose that if this case is opened, then other drugs will use the same reason to shorten the experimental cycle in the future, which will have an irreparable impact and threat to the domestic pharmaceutical market and patients' lives. Cheney replied.

"Ahem! Personally, I am very inclined to introduce these two new drugs as soon as possible. After years of exhausting his brain and spirit, Obama, whose temples have become mottled and gray, put his hands together and rubbed them, and from time to time recalled in his brain the rampant phenomenon of AIDS caused by the large number of drug abuse and ** among the black class in the Stars and Stripes country, and replied.

"But the lawyers are in their hands, and because of legal constraints, we can't directly get them to comply with the executive orders issued by our government." Cheney reminded, "In addition, I would like to remind everyone that due to the output ratio of new drugs announced in the early days of Yan Huang, the yellow version, the black version, and the white version are 100:10:1, so we will have many competitors in the future." There is news that many countries in Europe have begun to contact Yanhuang privately, hoping to get the first batch of new drugs to supply. ”

"I always thought that this ratio was deliberately made by the Yanhuang people, but in fact, it doesn't exist at all." Hillary shook her head.

"Maybe what you're saying is the truth. But now the Yanhuang people have mastered all the production processes and formulas of the new drugs, and they have all the good cards in their hands. Cheney smiled wryly.

"Is it still possible for our eyeliner inside Yanhuang to get a new drug formula or a chemical equation?" Hillary asked reluctantly.

"It's hard! Since Yanhuang carried out the largest anti-corruption campaign last year, the loss rate of the chess pieces we placed in Yanhuang exceeded 95%, and the rest are some small people who are not in high positions and do not matter. ”

"I remember that several of the richest people in China, past and present, have been infected with AIDS or cancer for some reason, what do you think if they start with the media to exert influence and resonate with the people?" Obama chimed in.

"What do you mean, President?"

"Jobs! Due to the early death of cancer, if there is a cancer drug, Jobs will live for at least 20 years, and Apple will maintain the halo of a magical company and continue to create great products, instead of constantly copying old products and staying at the level of a first-class company. I think we can mobilize some media to report more articles on this, and also expose the plight of some people with cancer and AIDS, and use the pressure of public opinion to force the lawyers' group to make concessions. ”

"Bednar's wife is in the early stages of breast cancer, and although he is 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, and behind the lawyers' group is actually them blocking new drugs. The starting point is only to ensure the market and profits of existing domestic anti-cancer drugs as much as possible. Of course, they are also one of the important providers of our campaign funds. Cheney nodded.

"A swarm of filthy parasites." Obama muttered in an extremely low voice, and then said, "We don't need to be completely at their mercy, or we will lose the gubernatorial race in the next continents, so let's do what we just said!" ”

"Yes, Your Excellency!"

The next day, January 7, 2014.

The New York Times, the most influential Stars and Stripes newspaper in China and known as the "Records of Cases", published a front-page headline of a well-known domestic writer, Jones?? John?? Winston's essay "life_or_principle" (Life or Principle) cites a lot of examples, detailing the helplessness and despair of celebrities or ordinary citizens in the last moments of their lives, highlighting the great significance and contribution of cancer pills and anti-moxa pills to mankind, so as to resonate with people. Naturally, Jones?? John?? Winston concludes by writing that if Jobs had not died, the Apple miracle would have lasted for another twenty years, which would have brought about tremendous domestic economic growth and provided a sufficiently attractive number of domestic jobs, and the development of the Stars and Stripes Republic would have required more Jobs.

The Washington Post, as the second largest newspaper in the Stars and Stripes, made full use of the convenience of its reporters, editors, and political circles to obtain documents related to the FDA's meeting materials from within, and bombarded the bureaucratic style and inhuman behavior of the FDA's internal lawyers' group in the form of exposing the "insider," which caused a great uproar in public opinion for a while.

The Wall Street Journal is much more interesting, a serious newspaper with few pictures and no color, and always charts. It devotes an entire page to detailing the recent situation and future prospects of major medical companies in the New York stock exchange market, as well as the impact of cancer pills and anti-moxa pills on their performance, and also predicts the trend of the New York Dow Jones pharmaceutical sector in 2014

Yanhuang Continent, Jinhai City Xingshang Diamond Mountain Community.

"Yadi, it's almost, the internal squabbles in the Star-Spangled Banner have nothing to do with us, we just need to wait for news. Isn't it time for a plan for domestic agriculture? Wang Fan looked at the debate on N Radio about new drugs and smiled proudly.

"There is no problem, I have already produced and stored agricultural materials, and they can be put into the market in large quantities at any time." Yadi replied.

"Haha, that's great, let's start the 'Rural Campaign' tomorrow!"