Using imported prescription medications can be a danger to your health. Imported medications and their ingredients, although legal in foreign countries, may not have been evaluated for safety and efficacy in the United States. And some imported medications may in fact be counterfeit versions that are unsafe or completely ineffective. If the drugs are ineffective, consumers may suffer complications from the very illness that their prescriptions were intended to treat.
The United States’ top concern about importing drugs is quality assurance. Federal law requires the FDA to inspect U.S. drug facilities every two years. Yet there’s no similar requirement for foreign sites. It’s estimated foreign manufacturers are inspected only once every 14 years. Patient-safety advocates say without the threat of inspections, foreign companies might have less incentive to use good manufacturing practices.
To give us a better sense of this growing epidemic, we spoke with Dr. David Gortler, Former FDA Medical Officer and Associate Professor of Pharmacology at Georgetown University. Dr. Gortler agrees that the main problem with foreign manufacturers stems from quality control.
“And I mean some of the complaints we see coming in from the federal register, and from Ranbaxy in particular, and from Wockhardt in particular, are outrageous. They they outrageous complaints of uh literally scientists forging records and ripping up old records and throwing them in the trash. And then one of the FDA inspectors actually finds the correct records. Um they've had complaints of individuals walking around sterile manufacturing plants barefoot. Um complaints of uh manufacturing scientists uh urinating into open containers. The list goes on and on. But the complaints are nothing less than outrageous. And and the FDA um fines these companies, they're they're certainly penalized for this kind of behavior. But producing generic drugs is so incredibly profitable for them that they continue to do it and they continues...it's worth for them to pay the fines.”
Poor quality control can lead to lesser efficacy and safety of the drug. Toxins, heavy metals, and sulfites have been found in drugs due to quick and shoddy manufacturing from foreign companies trying to maintain their bottom line. But manufacturers aren’t the only ones looking to save money. Insurance companies often require pharmacists to dispense the least expensive generic drug to patients. Oftentimes, that means foreign drugs.
“The insurance companies will go around to the different generic manufacturers and find out exactly which generic manufacturer is producing this drug cheapest. And when patients go to a pharmacy with their insurance card, they're forced...the pharmacy is forced to give their patients the least expensive generic available. And one of the ways that these companies make the least expensive generic drug is to cut as many corners as possible. “
So how can you tell if your prescription drug was manufactured overseas? Check the label. And check it closely.
“This is a drug made by Mylan Pharmaceuticals, which is a common, uh, uhm US, um, uh, it's it's an American company. And uh it's a name, which people have grown to trust for a long period of time. The company's been around for many decades producing generic drugs. And if you look at the bottle it'll it'll even say, "Manufactured for Mylan Pharmaceuticals, Morgantown, West Virginia, USA." But then if you look in even finer print under the address it says, "Made in India." And so, and these companies just like every other company which is concerned about the bottom line, is, are, is is producing their drugs overseas in the sweatshop countries.”
Next time you’re at the pharmacy, you may want to speak to your pharmacist and find out exactly where your medications are coming from.
I'm Ken Moll for Legal News Network -- your source for safety information.
For free consumer safety information and case updates, visit us at legalnewsnetwork.com.
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