the safety gap

by:Homkey Packaging     2020-10-19
At the age of 31, in the belly of an industrial zone in southern Lyon, France, just after a sulfur refinery and a synthetic vanilla plant,down, eight-
The story factory that made aspirin, the first pharmaceutical giant.
The Lyon factory is the last of its kind.
There are no other major factories in Europe and the United States that produce generic aspirin.
The market has been low-priced.
Cost Chinese producer.
Even the German company Bayer, which created aspirin in the 1890 s and struggled for more than a century to distinguish its products from the most trusted ones, now has spare parts from China
The Lyon plant is owned by a French chemical giant called Rodia, which has been producing aspirin since 1908 and still accounts for more than 25% of the world\'s aspirin market.
But a century after entering the industry, the company intends to stop producing aspirin altogether.
The last renovation of the plant was in 1992 and it needed to be upgraded in order to continue operations, an investment that the company could not prove in the event that it had become a brutal business.
In fact, Rodia will close another factory about 40 miles south.
This is a painkillers found in Tylenol.
It is also the last such facility in Western Europe.
This is a non-event in some ways.
Closure of European factories;
The opening of China.
Consumers like that their goods are cheap, like everything else, and so are aspirin.
China now produces about two
Third of all aspirin and ready to be the only global supplier in the worldtoo-distant future.
But is the factory safe in China? Who knows? The U. S.
The Food and Drug Administration, the European Drug Administration and other competent government regulators rarely, if any, inspect it. (
In contrast, Rodia\'s factory accepted F for the last time. D. A.
On July, it was routinely inspected by one or another country. )
Companies that import Chinese pharmaceutical raw materials, including aspirin, need to test these raw materials before they are used, and some companies also send private inspectors to China to ensure that suppliers use appropriate controls.
No pharmaceutical company wants its name to be synonymous with disaster, and the vast majority of drugs consumed in the United States are safe.
But some industry executives have told me that the price sensitivity of the generic industry makes it harder to fully review their low pricescost suppliers.
In China, thousands of drug manufacturers sell products in the local market, with meager profits and common counterfeiting and pollution.
In 2002, the Pharmaceutical Association, a trade organization in China, estimated that more than 8% peoplethe-
Prescription drugs sold in China are fake.
Contaminated products are more than just medicines, unfortunately four Chinese babies died this fall, 53,000 babies are sick of melamine, a toxic chemical illegally added to the water
Reduce infant formula, increase the number of proteins manually, and fool the quality test.
No ads for melamine
Contaminated baby formula milk powder from China has been found in the United States and has been found in other countries.
This is the latest in a series of foods --and drug-Security scandal
In recent years, China has exported toxic toothpaste, deadly dog food, toys made of lead paint and contaminated fish.
In a notorious example this spring, China manufactures a cheap fake instead of a dry pig intestine used to make heparin, which is used in dialysis and surgery patients to prevent coagulation.
As the number of deaths among drug users increases, F. D. A.
Pollution was found and contaminated drugs were banned.
Eventually, 81 people may die from allergic reactions, and thousands of people around the world are in danger. F. D. A.
Officials admit the agency should not approve China-
Heparin sold in the United States;
It turns out that the agency has never inspected the Chinese factory that made it.
Advertising attention to Chinese medicines has become so intense, just three weeks ago, Michael O, Minister of Health and Human Services.
Announced by Levitt, F. D. A.
It will open offices in Beijing by the end of this year and offices in Shanghai and Guangzhou next year.
The agency still plans to send inspectors to China from the United States. S.
But the offices will provide \"an infrastructure that will make these people more effective,\" Levitt said in the announcement \".
Over the past decade, China has jumped to become one of the world\'s largest suppliers of pharmaceutical raw materials, as the Chinese government subsidizes the construction of manufacturing plants that undercut prices around the world.
In the United States, where price competition is fierce, generic manufacturers are the first to look for cheaper drug ingredients in China.
Last year, generic drugs went to F. D. A.
1,154 plants offering active drug ingredients are listed: 43% of them are in China, and another 39% are in India.
There are only 13% people in the United States.
Brand drug manufacturers with higher margins have refused to buy raw materials from China for many years, but as their business is affected, even large pharmaceutical companies such as AstraZeneca and Bayer, baxter and Pfizer have announced outsourcing manufacturing to China.
I \'ve been writing about the pharmaceutical industry for over a decade, but I rarely write about topics that brands and generic manufacturers want to discuss less.
Almost all industry executives who speak for the article are anonymous.
Even the generic drug Association, a trade group that usually harks, is largely silent on the issue.
None of them seem to want to talk too much about the difficulties of managing the factory in a few time zones of 6,000 miles and a huge language and cultural divide. The F. D. A.
Managing consumer goods worth more than $1 trillion is equivalent to 25 cents per dollar spent in the country.
Among them, food sales were $466 billion, drug sales were $275 billion, cosmetics sales were $60 billion, and vitamin supplements sales were $18 billion.
The agency is responsible for monitoring the third of all imported goods from eggplant to eyeliner, microwave oven to monoclonal antibody, slaughterhouse to mobile phone.
However, as the age of imported inspectors and computer systems is less than 500 and the repairman has to retire to repair it, the agency is increasingly plagued by a sense of futility. Even the F. D. A.
The most determined defender now admits what\'s wrong.
Among them is Peter Barton Hutt, who served as general counsel for the agency during the Nixon administration and is widely regarded as the dean of the FBI. D. A.
Bar in Washington
I have interviewed Hutt dozens of times over the years and he has been working for F. D. A. No more.
Hutt told me earlier this year, \"This is a fundamentally collapsed institution that needs to be fixed.
\"It\'s not just about money.
This summer, 1,442 people across the country were sick of contaminated tomatoes.
Or maybe it\'s jalepino.
The panic has become familiar and the inability to quickly find sources of pollution is one of the agency\'s signal failures.
A 2002 law requires food processors and distributors to keep track of where and where food is going, but the government has not yet authorized standardized records --keeping.
Therefore, in response to the panic, investigators must dump a large number of conflicting packing lists and incompatible computer programs when competing to save lives.
To ensure the safety of imported drugs, F. D. A.
Rely almost entirely on their own inspection of foreign factories.
This was not a problem 30 years ago, when most of the medical products consumed in the United States were made here and in the United States. D. A.
Inspectors can drive to factories in their area.
Since then, most of these factories have been transferred abroad and can now be checked for decades.
Testified in Congress on April.
Janet Woodcock, director of F. D. A.
The United States drug center rarely spoke frankly about the agency\'s ability to work abroad. “The F. D. A.
\"The last century was not configured to regulate the global pharmaceutical industry of the century,\" she testified . \".
Other current and former adsD. A.
The officer I spoke with responded to Woodcock\'s warning.
Tim Wells is a field investigator and then in F. D. A.
, Now conduct a private audit of the pharmaceutical factory and see the loopholes in the agency\'s safety net.
\"A company I recently visited abroad has not been inspected for 10 years,\" he told me . \".
In addition to more frequent inspections, domestic inspections are also unannounced visits and more intense.
When inspectors find dangerous situations in domestic factories, they usually return quickly to ensure that they are fixed.
This is not the case with foreign factories.
In a report released on October
On the 22nd, the government auditor reported that from 2002 to 2007D. A.
Inspectors found dangerous situations in 15 foreign factories.
Auditors found that only one of the factories had been re-inspected within two years.
In any other case, the agency is confident that the foreign manager is committed to making changes.
This record is particularly bad in China.
In the past six years, F. D. A.
Of the 714 Chinese pharmaceutical factories exported to the United States, an average of 15 are inspected annually.
At the current speed, F. D. A.
It takes more than 50 years to visit all these Chinese factories.
In contrast, F. D. A.
Check the domestic pharmaceutical factory every 2 times. 7 years.
The inspectors volunteered to take part in hard overseas missions and it turned out that they did not like to travel to parts of Asia very much.
DeVaughn Edwards recalled: \"I have been to Taiwan once and after staying in a very good hotel for one night at first, I was transferred by car to a hotel closer to the factory for a few hours,\" once served as F. D. A.
He had been an inspector for 14 years before leaving in 2006.
\"The bed is made up of two mattresses on the floor.
There is no lock on the door.
You must hope that no one will come in. It was dark;
No amenities, no TV available.
There is a shared bathroom under the hall.
There was only one night there, but it was enough that you didn\'t want to visit the factory any more and didn\'t want to spend too much time there.
When inspectors do go to China, their reports sometimes look like a bureaucratic rendering of Mark Twain\'s \"innocent\" abroad.
\"For example, two F out of 2001 trips. D. A.
The inspectors visited a factory that exported hot news to the United States.
The factory has never been inspected. “The F. D. A.
The team met with delegates from Wenzhou in a hotel in Wenzhou.
Pharmaceutical Factory and. . .
\"Through public ferries, then corporate vehicles are transported to manufacturing facilities in Dongtou Island, off the coast of Wenzhou,\" their report said . \".
\"There is no street address or lot number and only the county and province give the address of the facility.
\"Once the team reaches what seems like a remote place, the inspector knows that the drug is made in another factory --
Someone who once had a similar name but recently changed it.
\"In fact,\" the report continued. \"The inspection found that there were three independent companies in Wenzhou.
Wenzhou No. 1 Pharmaceutical Factory
No. 2 Pharmaceutical Factory and No. 1 Wenzhou
3 pharmaceutical factories
Location of Wenzhou
F. A pharmaceutical factory has also been identified. D. A.
During its visit to Wenzhou, the inspection team learned that the company was operating under a new Chinese name;
However, the English translation of the name is not available.
So two inspectors flew back to the United States.
Taxpayer fees
Never checked a thing. The F. D. A.
Obviously not being able to call names is not a trivial matter.
For example, one reason the agency failed to check the Changzhou factory that produced the lethal heparin was that someone confused the name of the factory and concluded that the factory had been inspected.
The name of the plant in China is a relic of its once tightly controlled economy, often very similar, and the translation may vary.
For example, there are 57 separate drug master files-the basic F. D. A.
Record of factory name, location and approved product-
The name says \"Shanghai\"
Some are obvious repetitions, such as those that are not in Shanghai.
6 Pharmaceutical Factory \"and\" Shanghai 6 Pharmaceutical Factory \".
But other plants may be independent. Or maybe not.
It\'s too hard to say.
What makes the problem more complex is F. D. A.
Outdated technology
Its computer system is so bad that officials cannot know which names or which plants are real.
In order to determine which plants need to be inspected, institutional investigators must consult two incompatible databases, one of which lists 3,000 foreign pharmaceutical plants exported to the United States, and the other lists 6,800.
Which number is right?
No one really knows
Officials told House investigators that their best guess about the number of foreign drug factories exported to the United States was 2,967, while the Government Accountability Office recently speculated about 3,249.
In many cases, the agency is also unable to tell the factory the time of the last inspection (
Or, more importantly, never been checked)
Where they are and what products they produce.
The joint ports in Los Angeles and Long Beach received about 45% of the ships.
Trade to the United States, or about 5.
2 million containers per year.
When I visited on the 5th festival, the huge crane was unloading and loading more than 30 ships, each carrying about 2,500 containers.
About 40 to 50 containers.
A small part of the total.
It was transported by truck to about half a huge warehouse.
A mile from the portThere the F. D. A.
The Customs and Border Protection bureau cracked open containers that they thought were suspicious, then emptied the containers to a large inspection area in front of the bay, sorted out the boxes and crates, it\'s like a pathologist arranging organs in an autopsy.
There is some kind of food in every crate I see.
A crate comes from Indonesia with chicken products written on it.
Bird flu is recommended in Indonesia with chickenD. A. officials.
So they decided to take a look.
It turned out that there was chicken seasoning in the crate, but there was no real chicken.
However, the jar was sent for testing.
Deep inside the internal organs of the container, there is also a glass jar sambal terasi with hot sauce.
They may be sent back because F. D. A.
Manufacturers with low requirements
Acidic food in cans or cans registered with the agency.
High-on label
The olives in Italy lacked the nutritional information needed, so they went to Italy.
Jam jars made of figs and oranges indicate that they are produced near Ukraine, so F. D. A.
The inspector said he wanted to sample products of radioactive dust from the 1986 Chernobyl disaster.
As I strolled through this cornucopia, I realized that I saw similar products at professional grocery stores across New York.
My brother is a gourmet chef. I bet. D. A.
An inspection of his kitchen cabinet will result in a large number of suspicious foods being labeled improperly. The F. D. A.
After all, less than 1% of all imported products were inspected. This year, 18.
More than 2 million batches of food, equipment, cosmetics and medicines are expected to exceed 300. S. ports; the F. D. A.
454 investigators in 2007
One and a half per port
Review them.
Their task is almost hopeless because part of F is not capable, which makes them even more depressedD. A.
Share the most basic information with others.
For example, inspectors in Los Angeles are unable to know which Chinese imports of medicines or equipment should indeed be reviewed because they are unable to access the records of F. D. A.
Factory Inspection.
For example, if an agent knows an F. D. A.
Inspectors have identified significant issues in specific facilities and they can make sure to check the manufacturer\'s name on the shipping list.
But they don\'t know where to focus their attention.
\"The non-automated approach we are currently entering the screening cannot continue,\" F. WoodcockD. A. told Congress.
\"We need to be able to make sure that products and manufacturing locations are acceptable before the drug enters our country.
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View all New York Times newsletters. I met Yusuf K.
In the lobby of the Waldorf.
Hotel Astoria, home in Mumbai, enjoys staying at this hotel.
He greeted me warmly and quickly turned to what was at hand.
\"Let\'s go to dinner,\" he said, taking me to a nearby Chinese restaurant where the owner greeted him with his name and led us to a quiet table.
Hamied is chairman and general manager of the Indian generic giant Cipla.
A small man with sparse white hair and good health
Hamid custom suits have become part of the international communityhealth hero.
On September 2000, Hamied attended an international conference on AIDS and other diseases and promised to sell an AIDS drug cocktail for $600 per patient per year, then a small fraction of the price offered by big drug manufacturers.
He said to the audience: \"Friends, I represent the needs and aspirations of the Third World.
I represent the ability of the Third World, and above all, I represent an opportunity.
Before Hamied\'s announcement, most leaders and even many charitable organizations denied the possibility of treating poor Africans and Asians infected with AIDS. I. V.
The combination of drugs to stop infection costs $15,000 a year, and even those in rich countries are unbearable.
But, ignoring Western companies that hold patents on these drugs, Hamid changed everything, and his offer was later reduced to $350, then to $80.
Hamied undoubtedly saved many lives and, in doing so, proved how low the cost of effective drugs is.
Today, as more and more drug manufacturers look for manufacturers in China and India, prices for all kinds of generic drugs have fallen.
As a result, prices fell in industrialized countries and in the developing world. The A. A. R. P.
Earlier this year it was announced that prices for 185 widely used generic drugs fell nearly 10% last year, while prices for 220 of the most commonly used brands fell nearly
Drug names rose 7%.
Without low-cost advertising from Chinese and Indian producers, millions of people around the world may not be treated.
In the United States, purchasing generic drugs produced abroad is a way to reduce the soaring medical costs faced by companies and individuals.
But there is a danger: Some of these drugs may be ineffective or dangerous without proper regulation.
A 2006 study found that more than half of
Malaria drugs sold in Southeast Asia do not contain active ingredients.
The World Health Organization estimates that up to 10% of all drugs sold worldwide are counterfeit or contaminated.
In some poor countries, this proportion is over 30%.
At lunch, Hamied said that his factory routinely inspected and he provided an extensive inspection schedule.
In fact, international drug buyers say it may be difficult to get a few days to review the Cipla facility because, as an important supplier of dozens of companies around the world, Indian drugmakers have held a
End the flow of inspectors and auditors.
But like everyone else, CILA gets more and more medicinal ingredients from plants in China.
\"Yes, I have heard all the stories about the factory problem in China,\" Hamid said . \".
But he added that he trusted his Chinese partners.
Many international drug buyers say buying drugs from Indian companies is much more comfortable than buying them from Chinese companies.
Language is one reason, but another is that corruption is not common in India.
\"We have not had problems with the Indians we have met with the Chinese,\" said William F . \".
Chairman and CEO of Biogenerics Haddad
\"There is something missing in China, which has a lot to do with corruption.
\"But a few weeks after I had lunch with Hamied, AmericaS.
S. Justice Department has announced a criminal investigation into Ranbaxy, India\'s largest drug maker, whose annual sales in the United States are $0. 39 billion.
In a motion filed by the Federal Court of Maryland, the Department of Justice charged Ranbaxy with \"a pattern of systematic fraud\", including filing forged drug data with the Federal CourtD. A.
Use of Medicinal ingredients in unapproved and untested plants.
The Justice Department has charged the President\'s Emergency Plan for AIDS relief with one of the drugs involved.
The leader of a committee in the House. D. A.
A letter dated July stated that court documents showed that officials of the agency were aware that the allegations had been 18 months and had done nothing.
September, F. D. A.
The import of more than 30 generic drugs produced by Ranbaxy is prohibited on the grounds that violations may result in contamination and allergic reactions.
June is a hot day,
The director of the Food and Drug Administration, Andrew von essenbach, dressed as usual in a dark suit, wore a white shirt with a letter pattern on it.
His gold cufflinks and his \"good friend\" Lance Armstrong\'s yellow \"Livestrong\" wristband are visible.
He\'s obviously excited.
I visited John F with von Eisenbach.
Kennedy Airport International Mail Center
When I visited the ports in Los Angeles and merlong beach, the agency only agreed at the last minute to send its regional director.
Now I got an unusual journey.
With the commissioner of the agency.
In the coming weeks, the agency has gone from defending its oversight of the country\'s drug supply to agreeing that it is overwhelmed.
What is the reason for the change?
A bipartisan chorus on Capitol Hill condemned the agency\'s failure.
Finally, I promised to have more money.
We\'re in a cage, a 30-foot-by-20-
Foot area of customs and F. D. A.
The inspectors do their work.
There are two to three. D. A.
In nearly one illegal drug shipment, a large influx of inspectors assigned to serve as police officers.
3 million foreign emails through J. F. K. every day.
Mail staff pulls packages from countries that customs considers risky and throws them in \"cages \".
James Ng, Customs and Border Protection officer, passed X-ray machine.
A row of vials is on the picture.
\"When it looks like this, it\'s usually an internal anabolic steroid,\" Ng said . \".
He opened the box and put on a pair and a half.
Glasses, take out a small bottle full of white crystalline powder.
Ng said, then handed the vial to von Eisenbach, \"it says it\'s testosterone . \".
Feng Eisenbach says the ad \"is an incredible example\" and his eyes are bright.
\"It\'s a steroid from China, but the label is written in Spanish.
\"The customs found steroids and drugs, but they gave it to F. D. A.
The inspector effortlessly fills out the handwritten form and sends the letter to the intended recipient.
If the recipient swears that these drugs are for his or her own use, then F. D. A.
Frequently release detained packages
According to a 2003 congressional survey, it takes an hour or two to process each package, \"This is an obstacle that makes it functionally impossible for their work to be done \".
Thousands of packages can be piled up waiting for F. D. A.
Review, due to the lack of staff, the agency often releases packages without any investigation.
Even if there are inspectors working, they are not sure that every ingredient in the drug is safe. The F. D. A.
Almost all regulations and most inspection supervision are limited to the active part of most pills, which usually account for 1% to 10% of the volume of the pills.
Most of the pills are fillers, adhesives, paints, pigments and lubricants that are almost completely unregulated.
In the past 20 years, syrup for cough and fever drugs has had at least 8 mass poisoning cases around the world, and 3 of the last 4 cases have come from China.
On 2006, hundreds of people died in Panama, at least 88 children died in Haiti in 1995, and 1996 infants died in India in 1998 --
It\'s all poisonous syrup.
In 1937, 107 people died of similar toxic syrup in the United States.
In fact, it was this incident that led to the modern F. D. A.
However, the filling of pills and syrup and other plants that are not medicinal components, if any, are rarely F. D. A.
Or any other regulatory authority.
Funding the agency through Democratic and Republican governments has been a problem.
The situation became so severe in early 1990 that drug manufacturers were worried that it would take the FBI three years. D. A.
Approve new drugs and agree to pay fees to speed up the review time.
But these companies impose strict restrictions on how to use these fees, and Congress agrees.
There are no cost-funded parts of the agency, such as the inspectorate and the department responsible for supervising drug safety that has been approved, where to start.
In fact, the number of people funded by Congress is F. D. A.
Between 1992 and 2007.
Since 1990, the United StatesS.
Imports grew by more than 900%.
Several independent evaluations of F. D. A.
Raised concerns about the organization\'s poor organization and shortage of funds
These shortages pose a danger to the country\'s food and drug supply.
Federal Council of scientific advisers. D. A.
A report was released last year that concluded that life in the United StatesS.
Citizens are threatened.
In February, the president asked Congress to provide the Federal Reserve Fund. D. A. with $1.
An increase of $77 billion in 2009 included an increase of $50.
7 million of the previous year was not even enough to pay a normal salary increase.
Over the next few months, von Eisenbach endured harsh criticism from congressional Democrats and Republicans.
Scandals involving contaminated drugs and food have continued, leading them to concludeD. A.
More foreign inspections are needed.
House Democrats held more than a dozen hearings highlighting the agency\'s shortcomings and urging the government to raise more spending.
Finally, after intense interrogation by the representative of John D.
Michigan Democrat ding Geer, chairman of the Energy and Commerce Committee, von essenbach has asked Congress for $0. 275 billion to ensure the safety of imported food, medicines and medical devices.
In June, the minister of health and public service, Levitt, urged Congress to act quickly, and Congress quickly and urgently injected $0. 15 billion into the agency this year and another $0. 15 billion next year.
Advertising, this is probably the moment F. Makes a difference. D. A.
There is strong bipartisan support on Capitol Hill to strengthen the agency and prevent the recurrence of heparin panic.
On January, Washington will usher in a new administration that could change no matter who wins the presidential election: Barack Obama and John McCain will not oppose regulation in philosophy as the Bush administration did.
Under Bush, the focus is on encouraging companies to hire private inspectors. D. A.
It has been tried for a while but nothing has been successful.
Congress has changed that.
As senior member of the House Energy and Commerce Committee, Texas Republican Congressman Joe Barton recently said, when it comes to reforming the agency to increase foreign drug inspections, \"There is no day between Republicans and Democrats.
\"Unlike the reform of general social security or medical insurance, fixed F. D. A.
This does not mean allocating huge amounts of money, nor does it mean that the system needs to be re-coordinated.
It just needs some money and will.
There have been legislative changes in the project.
Bills now circulating on Capitol Hill require food and medical care.
Equipment and drug manufacturers who pay annual registration fees to F. D. A.
These fees will be used to allow as many inspections as possible for foreign and domestic companies.
Our regulators also seem to agree that they cannot rely on China to regulate their factories.
China is wobbling between reform vows and ignoring US concerns about the quality of Chinese products.
When China first discovered melamine
Chinese government officials made pet food, denied the pollution came from China, and then, when the claim was overturned, they said melamine would not hurt pets.
Chinese officials acknowledged the pollution during the heparin panic, but insisted it was not fatal.
Last year, however, the Chinese government executed the former head of the agency responsible for the supervision of the food and drug industry.
He was found to have traded cash for untested drugs.
Many people were shocked by this punishment. D. A.
But it has also led some to believe that China is sending signals of a broader crackdown on unsafe food and medicines, and that hope has not yet been met.
More inspectors will certainly help, but even regular inspections of Chinese factories do not ensure safety.
Inspectors can be deceived;
Tests can be fooled.
\"No matter how many F. D. A.
Democratic Senator Sherrod Brown of Ohio said: \"They have checked and our safety is still at risk if the pressure continues to reduce costs.
Brown has introduced a bill requiring labels to disclose the country of origin of key drug ingredients.
Some lawmakers have even suggested banning all drugs that use Chinese ingredients, but China has become such an important supplier that the ban will lead to the collapse of the United States. S.
Health care system
Our dependence is growing: in October, when PricewaterhouseCoopers mentioned in a report to pharmaceutical companies the best pharmaceutical outsourcing sites in the world, its choice was China
Gardner Harris, a reporter from the Washington branch of the New York Times, reported on public health issues.
A version of the article appears on page MM46 of Sunday magazine with the title \"security gap \".
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