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Political news--February & March of 08
Prescription drugs from China sicken and kill Aamericans
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Doing as big PHARMA wants—ineffective regulatory review, Congress and the Presidents have reduced the FDA’s ability to regulate the drug industry.  This is free-market economics at work.  There is virtually no inspection of Chinese companies. 

 

FDA in crisis? Then show them the money

http://www.fiercepharma.com/story/fda-in-crisis-then-show-them-the-money/2008-02-04?utm_medium=nl&utm_source=link

Pony up, Congress. Stop whipping the FDA for its failures and fork over the cash necessary to fix the problem. That's what editorial writers at the Boston Globe and New York Times said over the weekend. "Congress should boost FDA spending to whatever level it takes to restore public trust in the agency," the Globe contended.

We all know the stats by now: Though 80 percent of drugs sold in the U.S. are made overseas, the number of import inspectors has dropped by a third, and only a handful of the thousands of foreign manufacturing plants are inspected each year. The FDA's $2 billion budget has dropped by $400 million in inflation-adjusted dollars over the last 14 years. Meanwhile, more than 100 statutes over the last 20 years have handed the agency new duties. As the Times points out, informed observers are nearly unanimous: the FDA is in crisis. Even Congressional Democrats and Republicans agree on this point.

The Bush administration has shown little appetite for the major increase in funding the FDA needs. Recently, it established a working group on the safety of imports but it stipulated that any reform proposals should be "within available resources.""The FDA desperately needs an infusion of money and talent," notes the Times. In another editorial--linked to coverage of a Chinese company that distributed tainted cancer drugs, paralyzing hundreds--the paper calls on Congress and the White House to "move quickly" to strengthen the FDA. We'll see if the government takes heed.

Oh, woe is the FDA. The Government Accountability Office is set to release a new report on the agency's terrifically inadequate inspection record overseas. According to the New York Times, which obtained a copy early, the FDA is so understaffed that it would need at least 27 years to inspect every foreign medical device plant and 13 years to check every foreign drug plant. Think that's bad? Catching up on food inspections would take a mind-boggling 1,900 years.  The attrition in personnel has been especially acute among inspectors of the exploding market in imported goods. While 80 percent of all drugs sold in the United States are made overseas, the number of import inspectors has plummeted, from 531 in 2003 to 380 in 2006. In 2007, the FDA inspected just 30 of several thousand foreign drug-making plants. It inspected just 100 of 190,000 foreign food plantsc

Most disturbing is the fact that the agency is farthest behind in--you guessed it--China, that bastion of impure and unsafe exports. China has more drug and device plants than any other foreign nation, and FDA inspections there are few, the Times notes.

Those resources are so insufficient that a former associate commissioner of the FDA, William Hubbard, told the Globe last year that the FDA checked just 2 percent of all food imports from China, a country with a record of shipping food contaminated by carcinogens, filth, and pesticides. Congress should boost FDA spending to whatever level it takes to restore public trust in the agency. Right now, it is failing in its mission to protect buyers of food and medicines.

The GAO will present this bad news at a hearing before the House Energy and Commerce Committee, which has been dogging the FDA for months now. One witness set to testify said, "This is a fundamentally broken agency, and it needs to be repaired." We advise the FDA to focus on the "repair" part of that sentence. Today will be painful, sure, but it could lead to a sorely needed increase in funding. If the stars and politicians line up just right, that is.

 

 

At least 82 Chinese companies at a Milan trade show, none of them certified, said they made pharmaceutical ingredients.

http://www.fiercepharma.com/story/gao-assails-fda-s-foreign-inspections/2008-01-29?utm_medium=nl&utm_source=pharma_drug%20safety

GAO assails FDA's foreign inspections 

FiercePharma January 29, 2008

 

By WALT BOGDANICH

Published: October 31, 2007, New York Times

This article was reported by Walt Bogdanich, Jake Hooker and Andrew W. Lehren and written by Mr. Bogdanich.

MILAN — In January, Honor International Pharmtech was accused of shipping counterfeit drugs into the United States. Even so, the Chinese chemical company — whose motto is “Thinking Much of Honor” — was openly marketing its products in October to thousands of buyers here at the world’s biggest trade show for pharmaceutical ingredients.

Other Chinese chemical companies made the journey to the annual show as well, including one manufacturer recently accused by American authorities of supplying steroids to illegal underground labs and another whose representative was arrested at the 2006 trade show for patent violations. Also attending were two exporters owned by China’s government that had sold poison mislabeled as a drug ingredient, which killed nearly 200 people and injured countless others in Haiti and in Panama.

Yet another chemical company, Orient Pacific International, reserved an exhibition booth in Milan, but its owner, Kevin Xu, could not attend. He was in a Houston jail on charges of selling counterfeit medicine for schizophrenia, prostate cancer, blood clots and Alzheimer’s disease, among other maladies.

While these companies hardly represent all of the nearly 500 Chinese exhibitors, more than from any other country, they do point to a deeper problem: Pharmaceutical ingredients exported from China are often made by chemical companies that are neither certified nor inspected by Chinese drug regulators, The New York Times has found.

Because the chemical companies are not required to meet even minimal drug-manufacturing standards, there is little to stop them from exporting unapproved, adulterated or counterfeit ingredients. The substandard formulations made from those ingredients often end up in pharmacies in developing countries and for sale on the Internet, where more Americans are turning for cheap medicine.

In Milan, The Times identified at least 82 Chinese chemical companies that said they made and exported pharmaceutical ingredients — yet not one was certified by the State Food and Drug Administration in China, records show. Nonetheless, the companies were negotiating deals at the pharmaceutical show, where suppliers wooed customers with live music, wine and vibrating chairs.

One of them was the Wuxi Hexia Chemical Company. When The Times showed Yan Jiangying, a top Chinese drug regulator, a list of 186 products being advertised by the company, including active pharmaceutical ingredients and finished drugs, Ms. Yan said, “This is definitely against the law.”

Yet in China, chemical manufacturers that sell drug ingredients fall into a regulatory hole. Pharmaceutical companies are regulated by the food and drug agency. Chemical companies that make products as varied as fertilizer and industrial solvents are overseen by other agencies. The problem arises when chemical companies cross over into drug ingredients. “We have never investigated a chemical company,” said Ms. Yan, deputy director of policy and regulation at the State Food and Drug Administration. “We don’t have jurisdiction.”

China’s health officials have known of this regulatory gap since at least the mid-1990s, when a chemical company sold a tainted ingredient that killed nearly 100 children in Haiti. But Chinese regulatory agencies have failed to cooperate to stop chemical companies from exporting drug products.

In 2006, at least 138 Panamanians died or were disabled after another Chinese chemical company sold the same poisonous ingredient, diethylene glycol, which was mixed into cold medicine.

China has an estimated 80,000 chemical companies, and the United States Food and Drug Administration does not know how many sell ingredients used in drugs consumed by Americans.

The Times examined thousands of companies selling products on major business-to-business Internet trading sites and found more than 1,300 chemical companies offering pharmaceutical ingredients. How many others sell drug ingredients but don’t advertise this way on the Web is not known.

If the Milan show is any guide, most, if not all, are not certified by China’s drug authorities.

China exports drug ingredients to customers in 150 countries, said Sun Dongliang, a Chinese trade official who helped organize his country’s Milan exhibitors. Many suppliers have passed inspections by drug authorities and sell active pharmaceutical ingredients, or A.P.I.’s, of high quality, buyers say.

Sometimes you can just have your lunch on the floor of the factory because it’s so clean and so perfect, sometimes much better than in Europe,” said Jean-François Quarre, a French drug company official who had a booth in Milan. But Mr. Quarre cautioned that he has seen the other side as well. “It’s frightening.”

At their worst, uncertified chemical companies contribute to China’s notoriety as the world’s biggest supplier of counterfeit drugs, which include unauthorized copies as well as substandard, even harmful, formulations. “Underregulated manufacturers are increasingly becoming the source of A.P.I.’s used in the production of counterfeit medicine,” R. John Theriault, until recently Pfizer’s head of global security, said in a statement to Congress.

Because United States drug regulators require pharmaceutical suppliers to meet high standards, the American supply chain is among the world’s safest. But as China’s chemical suppliers multiply, Congressional investigators are questioning the F.D.A.’s ability to protect consumers.

Even some Chinese chemical companies recognize their limitations in making pharmaceuticals.

“We don’t have the resources and means to produce medicine,” said Gu Jinfeng, a salesman for Changzhou Watson Fine Chemical. “The bar for producing chemicals is pretty low.”

Even so, Watson Chemical advertises that it makes active pharmaceutical ingredients. But Mr. Gu said he would export them only to countries with lower standards than China, or if “we can earn really good profits.”

A Trail of Steroids

Just days before the Milan trade show, United States officials made an announcement that brought home the global reach and attendant dangers of China’s expanding chemical industry. The officials disclosed that they had dismantled a 27-state underground network for steroids and human growth hormone, arresting 124 people in “Operation Raw Deal.”

The supply trail almost always led to China. Thirty-seven companies there supplied virtually all of the bulk chemicals, federal officials said.

Of the 37 suspect companies, all but one unnamed by the American authorities, The Times identified eight. Records show that six are uncertified chemical companies, including Hunan Steroid, which marketed its products at the Milan convention.

“Just want to see the old customers and develop the new market,” said Sun Xueqin, a deputy export manager for Hunan Steroid. Ms. Sun said the company sold raw pharmaceutical ingredients in Europe and America and more advanced pharmaceutical ingredients in India, among other places.

Later, another Hunan official, Huang Zili, said the company did not sell to the United States, and declined to comment on the government’s contention that Hunan was a supplier of bodybuilding drugs. Hunan has not been charged with any crime.

As serious as the accusations are in Operation Raw Deal, health experts say they believe that counterfeit drugs, particularly those sold on the Internet, pose a greater threat to a broader segment of the American public.

“The facts are irrefutable,” Mr. Theriault, the former Pfizer official, told Congress. “The importation of counterfeit, infringing, misbranded and unapproved pharmaceutical products in the United States is increasing exponentially.” Pfizer makes Viagra, one of the drugs most often counterfeited.

Finding uncertified companies feeding the market is not difficult. Orient Pacific International, the Milan registrant whose owner did not show up, advertised that it makes and exports pharmaceutical ingredients to “worldwide famous medical companies.” The owner, Mr. Xu, is accused of selling counterfeit medicine to treat ailments like cancer, mental illness and heart disease, according to United States Immigration and Customs Enforcement, or I.C.E.

Mr. Xu shipped drugs to an Internet pharmacy, investigators say. But he also penetrated the highly regulated supply chain of legitimate distributors in Europe, said David A. Faulconer, a customs official. Acting on tips from large drug companies, federal officials devised a plan to stop him from doing the same in the United States.

Posing as a buyer, an investigator for the immigration and customs agency met Mr. Xu in Bangkok on March 6. Mr. Xu gave him “detailed suggestions for transshipment and smuggling techniques to evade United States Customs detection,” federal records show.

After investigators bought multiple shipments of counterfeit drugs, Mr. Xu traveled to Houston “to consummate an agreement for widespread distribution of his counterfeit products in the United States,” according to an affidavit filed in federal court. Federal agents arrested Mr. Xu, who has pleaded not guilty.

Another company exhibiting in Milan, Honor International Pharmtech, was also the subject of a customs investigation. In January, agents seized 3,041 fake Viagra pills sent by the company to a DHL shipping hub in Wilmington, Ohio, according to customs.

The shipment, disguised as grape seed extract, was destined for an Internet pharmacy in Central America, said agents who requested anonymity because the investigation continues.

“We do make grape seed extract,” the company’s managing director, Nie An, said in a telephone interview. He denied shipping counterfeit Viagra, but he acknowledged other indiscretions: making false advertising claims, using another company’s import-export license and creating a fake corporate name.

“We don’t really have a factory,” Mr. Nie said, even though he advertised that he did. Honor International is just a trading company, he said, adding, “As a trading company, saying you can manufacture attracts business. It was fake advertising.”

The Times found several other companies posing as manufacturers, thereby obscuring a drug’s provenance. In a recent joint statement, chemical associations in the United States and Europe cautioned that globalization has led to a rise in complexity in supply chains, “increasing the potential for contamination, mislabeling or substitution.”

Pharmaceutical ingredients can pass through three or four trading companies, none of which check their quality. The ultimate manufacturer may not realize the ingredients came from an uncertified chemical company.

Mr. Nie, for example, said he markets Viagra’s main ingredient, sildenafil, through a partnership with a chemical company in a distant region that he has never visited. “We met them at a trade fair,” he said. “This company didn’t even have a booth at the fair. They were standing outside the entrance to the exhibition center, and they handed us a flier with a menu of their products.”

He said he was trying to the reach the factory, which has no Web site, to fill a Croatian company’s order.

“Our main markets are in Latin AmericaBrazil, Argentina, Uruguay,” he said. “A little in Canada, a little in the United States. In Europe, we export to Germany, Russia, Italy.”

But Mr. Nie faces an uncertain future. He said that Chinese investigators had recently visited his office, and that they knew about the seizure in Ohio.

Viagra is hardly the only drug that companies try to copy. The French drug maker Sanofi-Aventis grew weary of watching other companies sell knockoffs of its new diet drug, Acomplia, and alerted French authorities that three Chinese companies were marketing their own version of the product at the 2006 pharmaceutical ingredient trade show, held in Paris. Six Chinese company officials were arrested.

One of those arrested in Paris was Jin Lijie, managing director of the Wuxi Hexia Chemical Company. Still, Wuxi Hexia showed up in Milan in 2007 selling a line of pharmaceutical ingredients.

Its representatives declined to be interviewed in Milan, or at its offices in the boomtown of Wuxi. “We are all young college graduates and we are still learning about the market,” said an employee named Du Yanqun.

Factories on the Yangtze

A good place to find companies selling uncertified drug ingredients is Changzhou in the Yangtze delta, where the raw materials for chemical production are readily available and easily transported by canals and roads.

Several factories there sent representatives to Milan, including the Changzhou Kangrui Chemical Company. It makes pharmaceutical ingredients in an old converted steel plant. “I’m afraid it will leave you with a bad impression,” said Zhou Ladi, a sales representative, as she gave a tour. She said Kangrui Chemical hopes to move into a new plant by early 2009.

“As long as we don’t export products that are under patent in other countries, the government encourages us to export,” she said.

To help find customers overseas, smaller factories enlist the services of people like Bian Jingya, export manager for a trading company called the Changzhou Wejia Chemical Company.

Ms. Bian said chemical companies are involved in all phases of drug manufacturing, including making finished products. Some, she said, “are under patent in other countries.”

Ms. Bian, who was also in Milan, said the government should spell out more clearly what companies may and may not do. “If you want to be regulated, they will regulate you,” she said. “If you don’t want to be regulated, they don’t.”

The Chinese drug agency does not oversee the making of pharmaceutical raw materials, called intermediates, which are the building blocks for active pharmaceutical ingredients. “It is unrealistic for us to certify all factories that make intermediates and regulate them like medicine products,” said Ms. Yan, the agency official. But if companies make active ingredients, a more refined product, then they must be regulated by drug authorities, she said.

When The Times pointed out that many uncertified chemical companies openly advertise active ingredients, Ms. Yan said that was illegal. “If there are in fact chemical companies that are making drugs without certification then this is very serious,” she said. “These companies are not qualified to make medicine. They make chemicals.”

 

Wang Siqing, managing director of the Changzhou Yabang Pharmaceutical Company, estimated that uncertified chemical companies make half the active pharmaceutical ingredients sold in China. “The stuff produced by chemical plants is clearly counterfeit medicine, but they aren’t investigating,” Mr. Wang said in an interview at his office. “This has been happening in a regulatory void.” He added that most chemical company exports go to unregulated markets in Africa or South America. “That’s not to say these products don’t enter the United States through these other countries,” he said.

To find out how well American consumers are being protected from unsafe imported drugs, investigators from the House Energy and Commerce Committee recently accompanied F.D.A. officials on inspections of drug plants in China and India.

In a letter to the F.D.A. commissioner, the committee said that the agency was unable to provide such basic information as the number of firms exporting to the United States, and that overseas F.D.A. inspectors lacked necessary logistical support. A House hearing on F.D.A. oversight of foreign drug manufacturers is scheduled for Thursday.

“China alone has more than 700 firms making drug products for the U.S., yet the F.D.A. has resources to conduct only about 20 inspections a year in China,” said Representative John D. Dingell, the Michigan Democrat who is the chairman of the House Energy and Commerce Committee. The F.D.A. said it would answer the committee’s questions at the hearing.

Poisonings in Haiti

United States officials learned of problems with China’s chemical companies in the mid-1990s while investigating the fatal poisonings in Haiti. Chinese authorities took no action against the uncertified chemical company that made the poison, diethylene glycol, or the giant state-owned trader, Sinochem International Chemicals, that exported it.

A decade later another state-owned trading company, CNSC Fortune Way, exported the diethylene glycol — also from an uncertified chemical company — that ended up in the deadly Panamanian cold medicine in 2006.

Chinese officials have known for years that uncertified chemical companies are producing active pharmaceutical ingredients. In 2004 the Chinese drug authority’s newspaper cited complaints that some licensed companies “affiliate” with unlicensed ones to hide their illegal purchases, while others buy only a token amount from certified suppliers to pass inspection. “The impact of chemical products on the bulk pharmaceutical market hints at a much larger problem: a huge hole in drug safety,” the drug agency publication stated.

Since the Panama poisonings, China is considering ways to corral the chemical industry. At Panama’s request, Michael O. Leavitt, the secretary of health and human services, has pressed the Chinese government to step up regulation of chemical companies selling pharmaceutical ingredients.

American and Chinese health officials held their first high-level meeting in May, and hope to sign a memorandum of agreement in December. “The Chinese have finally come to the realization that their regulatory system needs repair,” said William Steiger, director of international affairs for Mr. Leavitt’s agency. But meaningful change will be difficult. Chinese authorities may not have enough investigators to weed out the many small chemical companies that are making drug ingredients.

And efforts to close the regulatory gap must overcome one particularly thorny issue: some uncertified companies accused of selling counterfeit drugs are owned by the government itself.

 

 

 

 

Overseas drugmaking goes unsupervised

FiercePharma   October 31, 2007

Look no further for a couple of gaping holes in our drug-safety fabric. Chinese regulators may be cracking down on some drug-safety violations, but plenty of chemicals companies aren't even being watched. Stateside, the FDA is struggling to track foreign drug makers--and that not very successfully.

First, the Chinese chemicals firms. According to a New York Times investigation,they're making pharmaceuticals ingredients, but many aren't certified or inspected by the government. They aren't required to meet any drug-manufacturing standards. Some even make finished drugs without any supervision whatsoever. And dozens of them--including known counterfeiters and poison-passers--came to a pharma trade show to sell drug makers on their products.

Next, the poor, underfunded FDA. According to a Congressional memo obtained by the Wall Street Journal, the agency can't even keep track of how many foreign drug makers it should oversee. And those it does know about are inspected only once every 8 to twelve years. Problems with foreign oversight were identified a decade ago--but they're still uncorrected. This at a time when drug and ingredient imports are skyrocketing. Agency officials say they do know who's importing drugs to the U.S. and that they focus inspections on products that pose the greatest risk. But they admit funding is down, and so is staffing.

Teddy Roosevelt's advice that, "We must drive the special interests out of politics. The citizens of the United States must effectively control the mighty commercial forces which they have themselves called into being. There can be no effective control of corporations while their political activity remains."