The FDA’s Role in Putting Tainted Medications in Our Hands

The federal government is supposed to have the American public’s best interests in mind when it comes to healthcare and regulating the safety of our medication. This is allegedly one of the reasons the Food and Drug Administration (FDA) made a big push to put a stop to importing cheaper prescription medication from Canada for several years. These drugs were unsafe, the FDA claimed, because the origin or safety of drug components could not be verified, much less their efficacy. Like a parent protecting a child, the FDA banned drug purchases from Canadian pharmacies for our own good.

But “Big Pharma” has become heavily dependent on foreign drug manufacturers, and the FDA can’t see its way to properly inspect those plants. The result is that our pharmaceutical drugs may be tainted and we don’t know any better than the FDA, the organization charged with protecting us, what is actually in our prescription medication. This can lead to a risk of serious injury, or worse, put patients at risk of death.

Drug manufacturers can’t keep up with the prescription medication demand in the United States, which has led to importing 40% of our medications and 80% of active drug ingredients from overseas manufacturers – many from Asia. The FDA is responsible for inspecting overseas plants, but the problem is twofold: there is a shortage of inspectors, and a shortage of translators. This forces the FDA to rely on the manufacturer’s translator. It’s a bit like the fox watching the hen house when FDA inspectors can’t independently verify the information they’re being provided due to a language barrier.

Compounding the problem is that the FDA announces its foreign inspections because they need to give the manufacturer time to secure a translator. This is not how the process is supposed to be done, and it presents the opportunity for foreign drug manufacturers time, in many cases, to clean up their act just enough to pass an inspection.

But are they truly passing?

Just some of the problems uncovered during inspections include:

• Flying insects in raw material storage rooms
• A mold-stained ceiling in a quarantine room
• Unclean and defective equipment that caused cross-contamination of drugs
• Product build-up in a room designated as being sanitized
• Destruction of records

Now that we have a new scare as the diabetes drug, metformin, appears to be tainted with high levels of NDMA, a carcinogen, there may be plenty of blame to go around starting with the FDA. Metformin, along with other drugs such as valsartan, losartan, irbesartan, and combination medications, have all been recalled in the last year due to concerns of NDMA tainting.

You should be able to depend on the safety of your prescription medication. It’s clear that we have no control over what we are actually ingesting when we take prescription drugs that are not carefully inspected by those charged with the task. If you or a loved one has become injured or died as a result of tainted prescription drugs, let the attorneys at Harris Lowry Manton LLP pursue a claim against those responsible. Schedule your free consultation with one of our personal injury attorneys by calling our Savannah office at 912-651-9967, our Atlanta office at 404-961-7650, or by reaching out to us through our contact page.