Personal Injury Blog

FDA Warns of Continued Risks from Defective Pharmaceutical Drugs Made Overseas

September 23rd, 2011
prescription drugs overseas

Lack of regulation overseas allow defective prescription medications to make it to US markets.

This week, Food And Drug Administration officials speaking before a Senate committee warned that Americans continue to be at risk from dangerous, defective pharmaceutical drugs manufactured overseas.  The risk to consumers from contaminated imported drugs was brought home to Los Angeles pharmaceutical liability lawyers a couple of years ago by the Baxter-heparin incident, in which dozens of people were killed.

Baxter’s blood thinner heparin contained ingredients that were manufactured in China.  In 2008, more than 80 people died after they were injected with contaminated heparin.  Baxter commanded about 50% of the heparin market in the United States.  Many of the patients who died from the contaminated heparin, suffered adverse reactions to the blood thinner.  Inspections by the Food And Drug Administration later found traces of contaminants in some batches of Baxter’s apparent samples.  The agency blames the contaminants for the adverse reactions that killed victims.

Later, additional investigations found that the Food And Drug Administration had not inspected the facility in China that manufactured the heparin for years.  In fact, the Food and Drug Administration failed to inspect the Baxter plant even before the agency granted approval to the drug.  According to Baxter, the company had conducted an audit of the facility just a few months before the heparin incidents, and found no problems with the facilities.  However, after the Baxter recall, the Food and Drug Administration visited the facility and found several safety issues.

It is these kinds of problems that the Food and Drug Administration is now warning against.  An agency representative speaking before Senate Committee said that such incidents involving contaminated foreign made products are still a risk.  The Food and Drug Administration now wants Congress to grant it more powers to prevent such incidents.  The agency wants Congress to give it the authority to force drugmakers to announce recalls in the case of contaminated, tainted or dangerous products.  It also wants the authority to establish a track-and trace-system that would monitor products from the time of production to the time they reach the consumer.  However, some lawmakers have already questioned the expenses involved in establishing a system like this.

The one thing that was made very clear from the Baxter scandal was how rarely the Food and Drug Administration inspects foreign drug manufacturing facilities, making it easy for defective pharmaceutical drugs to reach U.S patients.  In fact until recently, the Food and Drug Administration barely had a fully-functioning office in China, a country where many of the ingredients in pharmaceutical drugs and drugs are produced.

This is in spite of the fact that about 40% of the pharmaceutical drugs that Americans take are manufactured outside the United States.  Additionally, about 80% of the active ingredients in pharmaceutical drugs are sourced outside the country.

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