Our Terms of Service and Privacy Policy have changed.

By continuing to use this site, you are agreeing to the new Privacy Policy and Terms of Service.

Heparin contamination: Lawmakers want answers

By Parija Kavilanz, senior writer


NEW YORK (CNNMoney) -- Lawmakers scolded the FDA for still not knowing what or who was behind the contamination of the blood-thinning drug Heparin, nearly three years after launching its investigation.

The contaminated drug led to the deaths of dozens of people in the U.S.

"It has been almost three years since the the FDA linked deaths and serious allergic reactions of patients to supplies of Heparin that came from China," Rep. Fred Upton (R-Mich.), wrote in a letter to Food and Drug Agency Commissioner Margaret Hamburg Wednesday.

Upton said the House Energy and Commerce committee, which he chairs, will conduct its own probe into the matter.

Neither the Chinese government nor the FDA has identified those responsible, even though FDA officials believe the contamination, with overly sulfated chondroitin sulfate, was economically motivated, according to the letter.

Upton said, "some of the individuals responsible for the adulteration are actively engaged in the Chinese pharmaceutical supply chain and pose a continuing threat to pharmaceutical products imported to the U.S."

Heparin is administered to about 12 million people in the U.S. annually, the committee said.

The agency has two weeks to submit all documents related to Heparin-related inspections conducted in China and possible sources of adulteration.

FDA spokeswoman Karen Riley said the agency will review the letter and respond directly to lawmakers.

FDA under the gun: Lawmakers are increasingly questioning why so many problems with drug manufacturing quality have gotten by safety regulators.

FDA officials appeared before lawmakers twice in 2010 regarding several recalls of Johnson & Johnson's (JNJ, Fortune 500) popular over-the-counter drugs such as Tylenol and Motrin.

The agency announced an investigation -- including a criminal probe -- into those recalls last summer but has not yet issued its findings.

While many drugs are manufactured in the U.S., a growing number are coming from China, which poses a challenge to regulators.

80% of all active pharmaceutical ingredients used in drugs sold in the U.S. now originate overseas, according to the U.S. Government Accountability Office. China is the top supplier of those ingredients.

The FDA typically inspects drug manufacturing plants in the U.S. every two years.

But with 1,000 or more drugmaking plants in China supplying U.S. companies, not every facility can be inspected on a three-year schedule, said Allan Coukell, director of medical safety with research firm Pew Health Group.

The FDA conducted 52 inspections in China in 2009, said agency spokeswoman Riley.

In China, the FDA only has 13 officials spread out in Beijing, Guangzhou and Shanghai. However, most inspections overseas are done by U.S.-based employees sent on site, she said. To top of page

Index Last Change % Change
Dow 15,932.85 272.67 1.74%
Nasdaq 4,326.61 59.77 1.40%
S&P 500 1,859.99 30.91 1.69%
Treasuries 1.75 0.10 6.33%
Data as of 3:36pm ET
Company Price Change % Change
Bank of America Corp... 11.97 0.81 7.24%
General Electric Co 28.16 0.71 2.59%
Cisco Systems Inc 25.24 0.57 2.29%
Freeport-McMoRan Inc... 5.53 0.64 13.07%
Activision Blizzard ... 28.68 -1.84 -6.05%
Data as of 3:21pm ET
Sponsors

Sections

Investors need someone they can bring home to mother instead of bad boys (or girls) that may make their heart beat faster. Boring beats bold in this market. Here are 10 dependable stocks we love. Southwest (ticker symbol: LUV) is one. More

Cheap oil and slow global growth may not be the only culprits of the global market turmoil. There's growing concern that central banks are spooking the markets too. More

Emily Cole, cofounder of Liquid Light, has pioneered technology that recycles carbon dioxide into fuel that can replace petroleum in consumer products. More

Eastern Illinois University laid off 198 staff members this week, and the college president is blaming the state government. More