NunoftheAbove

After toxic toys, poisoned dog food, tainted baby formula, and deadly pharmaceuticals, the FDA is making the first step to provide real US oversight on the billions of dollars in imports from China.

BEIJING, China (CNN) — The first foreign office of the U.S. Food and Drug Administration opened Wednesday in Beijing after an influx of contaminated Chinese food and drug imports to the United States.

The FDA said it also planned to open offices in the Chinese cities of Guangzhou and Shanghai in the next few days. Subsequent locations would include India, the Middle East, Latin America and Europe.

FDA employees would inspect products and liaise with Chinese officials and groups, the agency said.

The United States intends to help the Chinese government improve its regulatory systems for exports, according to a recent statement from the U.S. Department of Health and Human Services, the FDA’s umbrella agency.

“Establishing a permanent FDA presence in China will greatly enhance the speed and effectiveness of our regulatory cooperation and our efforts to protect consumers in both countries,” the HHS statement said.

It is about time that the FDA began to shoulder its responsibility for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products . . .

Previous Posts:

China Delays New FDA Offices

FDA Blocks Import of Generics From India

FDA Addressing Tainted Heparin — Finally

Congress Investigates Tainted Heparin

Updated: Plant pinned as source of fatal drug reactions unlicensed by Chinese

RU 486 maker under investigation by Chinese government

The oversight of drugs from foreign producers, particularly India and China, has been a concern of many particularly with the deadly Heparin incident earlier in the year.  Now two plants in India have come under scrutiny for manufacturing potentially harmful production practices.

ROCKVILLE, Md., Sept. 16 — The FDA said today that it will not permit 30 generic drugs, including formulations of acyclovir (brand name Zovirax), ciprofloxacin (brand name Cipro), and simvastatin (brand name Zocor), made at two Ranbaxy Laboratories plants in India, to enter the U.S. The FDA said, however, that it was not ordering any Ranbaxy drugs off the shelves, noting that it considers drugs already in the U.S. to be safe.

The action covers generic drugs produced by Ranbaxy’s Dewas and Paonta Sahib plants.

The FDA’s action, which followed more than two years of negotiations and warnings to Ranbaxy, was “more about process than products,” said Deborah M. Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation.

She said Ranbaxy had repeatedly demonstrated a lack of compliance with the FDA’s safe manufacturing standards.

The FDA said that although Ranbaxy is “one of the largest suppliers of generic drugs to the U.S. market,” the import alert was not expected to cause any drug shortages, with one possible exception. The company is the sole manufacturer of ganciclovir sodium capsules.

To avoid any potential shortage, the FDA has exempted ganciclovir sodium, as well as the ganciclovir active pharmaceutical ingredient, which is also made by Ranbaxy, from the import alert.

The affected drugs, which will be stopped at the border, are: acyclovir, cefprozil, cefuroxime axetil, cephalexin, ciprofloxacin HCl, clarithromycin, fenofibrate, fluconazole, fosinopril sodium, fosinopril sodium and hydrochlorothiazide, gabapentin, glimepiride, isotrentinoin, lamivudine, loratadine OTC, metformin HCl, nefazodone HCl, nitrofurantoin, nitrofurantoin and macrocystalline, ofloxacin, pravastatin sodium, ranitidine, simvastatin, terazozin HCl, valacyclovir HCl, and zidovudine (PEPFAR).

The increase and dependence in the US upon imported pharmaceuticals should be a continuing cause of concern to both consumers and the FDA.

Despite recent concerns after the importation of deadly, tainted Heparin efforts to establish additional FDA monitoring offices within China has been stymied by the Beijing government.

HHS Secretary Mike Leavitt on Friday said that Chinese bureaucracy has delayed plans to establish FDA offices in three cities — Beijing, Shanghai and Guangzhou — that would monitor exports of food, medications, medical devices and other consumer products to the U.S., the Associated Press reports. Leavitt said that the Chinese Ministry of Foreign Affairs must formally approve the plans, after which the agency will begin the process of approval of diplomatic visas for the 13 FDA employees who will staff the offices.

Read entire story here.

Additional offices are also planned for another leading exporter of pharmaceticals, India, where

“There are 90 to 100 FDA-inspected facilities there producing mostly drugs and medical devices,” adding, “I expect that number to grow. The connection between the U.S. pharmaceutical industry and India is real and expanding. We just need to be there.”

These additional inspections offices are a welcome but perhaps insufficient solution to the US outsourcing of more and more of its drug raw materials and generic compounds.

Prior Posts:

Congress Investigates Tainted Heparin

FDA Addressing Tainted Heparin — Finally

Updated: Plant pinned as source of fatal drug reactions unlicensed by Chinese

Update: Washington Post, March 19, 2007

Lethal Chinese Heparin May Be Counterfeit

The harmful contaminant found in tainted heparin that was produced in China for U.S. patients is a modified form of a cheap and widely used dietary supplement sold to relieve joint pain, Food and Drug Administration officials said today.

They said they still didn’t know whether the ingredient was intentionally added to create counterfeit heparin or whether it was added by mistake, but they said it could not have been part of the prescribed manufacturing process.

In a statement, Sen. Edward M. Kennedy (D-Mass.), chairman of the Senate Health, Education, Labor and Pensions Committee, said that the FDA’s announcement today described a situation that is “unacceptable.”

It is comforting to know that Senator Kennedy also find the situation “unacceptable.”

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China Plant Played Role In Drug Tied to 4 Deaths

A Chinese facility that hasn’t been inspected by the U.S. Food and Drug Administration made the active ingredient in much of the widely used Baxter International Inc. blood-thinner that is under investigation after reports of hundreds of allergic reactions and four deaths among the drug’s users, the agency said yesterday.

Heparin is one of the most widely used and prescribed drugs in the United States. The four deaths included patients undergoing kidney dialysis with an additional 350 adverse reactions being reported. Neither Baxter nor the FDA has been able to identify which ingredient is responsible, but production has been halted of the generic version of the blood-thinner pending further investigation. While the number of deaths reported so far is small, however tragic, the implications are too far-reaching to ignore.

China is now the world’s largest producer of active pharmaceutical ingredients — the chemical compounds needed to make finished pills and other drugs. In 2005, China had $4.4 billion, or 14%, of the world’s $31 billion market for active drug ingredients, according to a report last year from Credit Suisse.

China’s explosion of exports to the economy conscious US has seen recall from dangerous toys, to toxic toothpaste, to poisonous dog food. Domestic regulatory agencies are woefully understaffed to provide adequate inspection for any significant percentage of imports and the Chinese officials do not have either the means or desire to provide quality assurance for exports.

China and India currently provide significant portions of the active ingredients used in pharmaceuticals consumed in the US, but less than 10% of foreign pharmaceutical manufacturers are being inspected yearly by the FDA.

The inevitable headline might as well be written because without closer scrutiny of the imports of pharmaceutical products from China, it is only a matter of time before a major, deadly debacle occurs. After which will follow the finger pointing and congressional hearings, all too late for those innocent consumers who took medicine to cure and instead were killed.

UPDATE:

It has now been reported by multiple sources that the suspected plant was not licensed by China to produce pharmaceuticals. The following is from a story by the International Herald Tribune.

Because the plant, Changzhou SPL, has no drug certification, China’s drug agency did not inspect it. The United States Food and Drug Administration said this week that it had not inspected the plant either — a violation of its own policy — before allowing the company to become a major supplier of the blood thinner, heparin, to Baxter International in the United States.

In December, American and Chinese regulators signed an agreement under which China promised to begin registering at least some of the thousands of chemical companies that sell drug ingredients. Some of these companies are the source of counterfeit or diluted drugs, including those used to treat malaria.

Note the key words “at least some”(emphasis added by nun). The uproar caused by the “expected” shortfall flu vaccination in 2006 spurred the administration into action. What will it take to bring public and governmental attention to this peril. When a “mistake” of major proportion does happen, perhaps those who have blindly accepted WalMart and its competitors’ miraculous ability to suddenly offer $4 drugs will wonder if they truly got a bargain.