Tainted Drugs:  Cheap, Imported, and Even More Deadly


Christopher Stombaugh

It’s a stop we’ve all made a hundred times. Pick up a prescription drug without a thought about how or where it was made, back in the car, and on the road again. But the days of getting a prescription from the neighborhood pharmacist like they’re a family friend are giving way to a danger from fake prescription drugs. Phony or tainted prescription drugs are eclipsing illicit street drugs, like cocaine or heroin, in sales, with even larger profit margins.

Both the Food and Drug Administration (FDA) and the World Health Organization (WHO) have warned that parts of the world’s drug production pipeline have dangerous quality control problems. Counterfeit drugs made with anything from highway paint to anti-freeze are not unusual. In 2008, dozens of Americans died from a fake heparin component that was manufactured in China.

American generic drug makers are, in fact, financing a US government crackdown on counterfeit drugs through additional fees. The FDA inspected 160 drug plants in India last year – three times as many as four years ago – but it is an uphill task because no one knows how many companies are supplying phony websites.

As consumers, 80% of us routinely substitute a generic for the brand-name drug because it costs less. Cheaper, yes, but at the same time we’re also unwittingly surrendering many of our legal rights by choosing the generic substitute.

That’s because 2011 ruling the U.S. Supreme Court held that unlike name-brand manufacturers, generic drug makers were not required to update their warning labels. That means the generic company cannot be held accountable for not warning consumers about newly discovered side-effects.

When accountability is removed there isn’t much motivation for a manufacturer to do the right thing, especially if it impacts profits. While FDA approval of a drug is significant, it doesn’t guarantee safety since the agency relies on the manufacturer to disclose side effects. Until this ruling, consumers had some degree of protection because a manufacturer could be held accountable in court.

Now the FDA is stepping in with a proposed new rule which says generic drug makers can, in some circumstances, modify their labels without government approval. That means both brand name and generic manufacturers would both be required to tell consumers about side effects. If approved, the new rule would again give consumers legal recourse for tainted drugs.

There are things all of us can do to make a difference in this “new” war on drugs:

The FDA is accepting comment until March 13th on that proposed rule change which will benefit consumers.  Go online at www.fda.gov to voice your opinion.
If you suspect a drug is fake or counterfeit don’t take it. Return it to your pharmacist. Broken capsules, odd odors, and misspelled labels are all telltale signs of a phony drug. You can also report it online to the FDA’s Medwatch program or call 1-800-332-1088.

Shop at a reputable bricks-and-mortar pharmacy.  Counterfeit drugs are less likely to turn up in the US than other countries, but minimize your risk by dealing with a reputable pharmacy.

Be wary of online deals for any drug. A website may look legitimate but you really have no idea where the drugs come from or how they are actually made.

Just because a prescription drug is made overseas doesn’t necessarily mean you should be concerned.  There are millions of safe, well-made, and effective prescription drugs coming into the US every day from foreign companies.

The world has changed and not always for the better.  Because the stakes are so high and the profits are potentially massive it is more important than to be pro-active, well-informed consumers.

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