183. Battered FDA
The President’s office.
The President was on the phone with Chairman Jung.
“The vaccine development is complete, so why aren’t we selling and administering it yet?”
– It’s delayed due to vaccine and new drug approval administrative procedures. At this rate, approval will be granted in three months at the earliest. It’s the same in the United States.
“Good heavens!”
– We need emergency approval, Your Excellency.
“An umbrella is needed during a downpour; what good is it after it stops? The saying ‘locking the stable door after the horse has bolted’ perfectly fits this situation. I will take action quickly. This is when we should exercise our power.”
The President, after hanging up, instructed the administration.
“For statutory infectious diseases, WHO [World Health Organization] pandemics, and other urgent illnesses, drastically simplify the approval process for new drugs and vaccines, and revise the law to allow for emergency approval!”
“Yes, Your Excellency!”
However, some members of the National Assembly [South Korea’s legislative branch] put the brakes on with cautious arguments.
“Medicines can be fatal to the human body, so we cannot tolerate hasty reviews. It is not fair compared to other medicines.”
The Minister of Health and Welfare said.
“We haven’t skipped the safety tests; we’ve completed them. We are only simplifying the complex administrative approval process and the lengthy procedure of re-examining after-effects after administration. If a member of your family were to contract the Hong Kong flu, would you still say that? People dying from infectious diseases are racing against every second, Assemblyman!”
While the National Assembly was arguing, the President made a decision.
“You fools! If we miss this opportunity, the disease will spread, and the vaccine will become useless! Minister, implement it first with a presidential decree!”
“Understood, Your Excellency!”
The amendment to the Pharmaceutical Affairs Act was changed by the President and implemented immediately.
Since the National Assembly’s law is superior to the presidential decree, the presidential decree would be suspended if rejected by the National Assembly, but it was implemented first to pressure the National Assembly.
A hard-line lawmaker foamed at the mouth.
“This is the President’s dictatorship! It is an arrogant act that insults the National Assembly!”
The President didn’t bat an eye.
Vaccinations began with the elderly, medical personnel, and key industry workers.
While the Legislation and Judiciary Committee was bickering, the first Hong Kong flu patient finally appeared in Korea.
In just one week, the number of patients increased to about 100.
The patients’ families stormed the offices of the opposing lawmakers and staged a violent protest.
“You and your family should get it too! Let’s die together without treatment or a vaccine!”
The lawmaker was terrified of being infected and ran away.
The media also followed the lawmakers who were blocking progress and running away, like paparazzi, and interviewed them.
“Assemblyman, why are you running away? Have your views changed?”
“Get that camera away from me!”
The National Assembly, facing a barrage of public criticism, hurriedly passed the bill.
Korea Pfizer was operating its vaccine factory at full capacity, 24 hours a day.
The production of flu treatments also began.
The world entered a war to secure vaccines.
*
Cabinet meeting.
The Minister of Health and Welfare reported.
“Vaccinations are underway domestically, and we have secured enough supply. The problem is the overseas supply. The quantity is limited, but there are so many countries that want it that I am worried about which country to export to first. Your Excellency, should we export to the United States and Europe, which are offering more money?”
“Postpone the United States until they approve emergency approval of the Korea Pfizer vaccine in the United States. They are hesitating to protect their own people’s lives, so tell them to take responsibility.”
“Understood.”
If the huge American factory was running, the quantity could increase more than threefold.
The President issued instructions.
“Now, let’s set the distribution and pricing policies for vaccines and treatments like this.”
“Please tell us.”
“The principle is to distribute vaccines evenly to countries in need, in proportion to the number of patients. But vary the supply numbers and prices.”
“……”
“For example, charge advanced countries with high GNP [Gross National Product] more than double the price and give it to them first. Supply it to low-income countries at half price later.”
“Ah, you mean to make sure that the advanced countries that bought it expensively first don’t complain?”
“That’s right. We have to provide service for the expensive price. WHO will support half of the vaccine and treatment costs for low-income countries. Half price and then half price again, so we can supply it to low-income countries almost at the level of relief supplies.”
“Understood, Your Excellency! Then, does WHO support Hong Kong as the country that reported the first outbreak?”
“Support them for now. But the money will probably have to be paid by someone else instead.”
“……”
The minister did not know what the president meant by the words he received in detail from the WHO Secretary-General regarding the interim report on the epidemiological investigation.
“Hahaha, Minister, just focus on domestic quarantine. I’ll take care of foreign affairs.”
“Yes, Your Excellency!”
*
The President’s office.
The President was receiving an international call from the White House in the United States.
– Your Excellency, we would be very grateful if you could allocate it to the United States first, as it is a blood-sworn ally.
“Well, I would like to do that, but the quantity is so insufficient. It would be a relief if emergency approval of the Korea Pfizer vaccine in the United States was approved.”
Because it was not an American-owned company and was a new drug co-developed with Korea, the U.S. Food and Drug Administration (FDA) was conducting a strict review.
– The FDA is an independent organization, so the administration’s influence does not work.
The U.S. FDA is an administrative organization under the U.S. Department of Health and Human Services, which corresponds to Korea’s Ministry of Health and Welfare, and mainly manages the efficacy and safety of not only food, drugs, and cosmetics produced in the United States, but also imports and some exports.
There was a reason why the FDA was trusted worldwide even though it was an administrative organization in the United States.
In the early 1900s, abuse of incorrect medicines and collusion between doctors and pharmaceutical companies in the United States led to the prescription of drugs containing narcotics or radiation.
This resulted in numerous side effects and deaths.
Decisively, after Eben Byers was prescribed ‘Radithor’ drinks containing radium by a doctor and drank 1,400 bottles for three years, resulting in a miserable appearance and death, the U.S. political world gathered these cases and thoroughly investigated the U.S. medical community and pharmaceutical companies, giving the FDA enormous authority.
Clearly, despite being a government agency in one country, not an international organization or a neutral academic group, FDA certification was recognized internationally everywhere thanks to its independence-guaranteed reliability.
However, there were also many criticisms that it was a non-tariff barrier that the United States was trying to monopolize medicines by setting strict standards for foreign countries.
“If approval is not granted in the United States and the factory cannot operate, I am afraid I can only give you the same answer.”
– We will give you a sufficient price, Your Excellency!
“In a supplier-dominant market like now, price increases are possible. We prioritize human life over money. The United States should also seriously consider this opportunity. It seems that it is time for American public institutions to awaken to whether sacrificing human life for the authority of the FDA is the right thing to do.”
– This is really difficult.
“If administrative power does not work, try pressuring the FDA with public opinion. It is okay to disclose today’s call details to the media.”
– Would that be okay?
“Of course.”
– Thank you!
*
The White House spokesperson briefed.
“The President is making every effort to reduce the victims of this Hong Kong flu and introduce vaccines and treatments. This morning, he spoke with the President of Korea to discuss the introduction of the Korea Pfizer vaccine. However, the FDA’s slow review is holding us back. Listen to the call details.”
The call details with the Korean President were edited and released in an inflammatory manner.
– It would be a relief if emergency approval of the Korea Pfizer vaccine in the United States was approved. It seems that it is time for American public institutions to awaken to whether sacrificing human life for the authority of the FDA is the right thing to do.
The spokesperson said.
“Korea has made it clear that supply within the United States is only possible if Korea Pfizer’s approval is granted within the United States. That’s all.”
The patients’ families rose up like a swarm of bees.
In particular, the families of those who died from infection were furious in front of the media cameras.
“Having to wait another year to see drugs that have already been confirmed safe in Korea is the FDA’s absurd stubbornness. Who is the FDA for, while being run with the people’s taxes? We will storm the FDA right now!”
In front of the FDA building, despite the guards’ warning shots, thousands of angry crowds threw stones and pushed down the main gate.
They formed a human chain around the building, holding pictures of their dead daughters and shouting at FDA employees.
“Are you God? Do you think you have the right to take human lives?”
“Be ashamed, FDA!”
“People are dying because of your bureaucracy and authoritarianism! Give me back my taxes!”
More and more citizens surrounded and blockaded the FDA.
The management reported it to the state police.
“They are destroying and invading government buildings and holding illegal demonstrations. They are deliberately spreading the Hong Kong flu! Arrest them immediately!”
– We will.
And then, the public power sent by the police was only one road patrol car.
A female police officer shouted with a megaphone.
“Everyone, please disperse (or not)!”
She shouted only one sentence and went back.
It was then.
Bang-
A gunshot rang out from somewhere, and a bullet hole was made in the FDA building’s window.
Armed police were immediately dispatched to investigate, but the culprit was not found because it was a bullet fired from afar.
As the atmosphere turned ominous, the FDA spokesperson issued an emergency statement.
“Based on the severity of the Hong Kong flu, we have decided to invoke emergency approval rights for Korea Pfizer’s vaccine and treatment.”
The production volume was increased fivefold by entrusting production to not only Korea Pfizer’s pharmaceutical factory in the United States but also other large American pharmaceutical manufacturers.
As treatments and vaccines were rapidly distributed worldwide, the Hong Kong flu, which was approaching 1 million infections, began to subside rapidly.
Bundles of dollars flowed into Korea Pfizer like a river.
*
The President’s office.
The President was on the phone with Chairman Jung.
– Your Excellency, Korea Pfizer’s monthly sales are more than Korea’s annual exports of shipbuilding and automobiles. Korea’s exports this year are expected to increase more than twofold.
“Hahaha. With exclusive production, the global village is waiting in line. There is no business like this.”
– It’s not just the company that benefits, but the patients are also being treated, so it’s really a win-win situation.
During Chairman Wang’s time, 3 million people were infected, of whom more than 30,000 died, but this was prevented with 1.2 million infections.
“It’s not easy for a company to make a lot of money and be respected, but this time they did it right. It was the most successful fund investment.”
Since the National Wealth Fund and Tiger Fund were the major shareholders of Korea Pfizer’s stock, the dollars went straight into Korea’s wallet.
The next most important follow-up was to identify the country responsible for the outbreak.