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Does the FDA Have Authority to Control Foreign-Made Drugs?


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If you take a prescription drug, it doesn’t matter where the product is manufactured. You want to be certain that the product your doctor has recommended is going to perform the way it’s supposed to for your condition and when taken as directed. If bad side effects are a possibility, you want to know about that, too. That’s your right.

FDA Obligations

The Food and Drug Administration has the responsibility of making sure that any drug that is legally prescribed in the U.S. complies with certain safety standards. If the drug happens to be made in a plant in Houston or in Timbuktu, the FDA is obligated to ride herd.

As it happens, that is proving to be something of a growing challenge. A lot more of the controlled drugs we use are coming into the country from foreign sources. In fact, the number of imports doubled just between 2004 and 2009.

According to The New York Times, India is the second-largest shipper of over-the-counter and prescription medications to the United States and it has been the focus of stepped-up quality control efforts in recent years.

In one recent case, two top Indian drug firms voluntarily recalled batches of products. The actions came even as the firms were under previous FDA orders to shape up and improve production methods at their plants.

The drug in question in one instance was an extended-release form of the antidepressant bupropion hydrochloride. The FDA said it didn’t dissolve according to expected standards. In another case, a form of the blood pressure drug lisinopril was recalled because of bad manufacturing processes.

Neither of the products was deemed to pose a threat of serious adverse health effects. But that isn’t always the case. When the injury is caused, victims should learn the avenues that may be available for possible recovery and compensation by consulting a pharmaceutical litigation attorney.

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