FDA device will screen for fake medicines overseas

April 24, 2013 by Matthew Perrone

U.S. health officials are making a high-tech screening device available to African authorities to help spot counterfeit malaria pills in hopes that the technology may eventually be used to combat the fake drug trade worldwide.

The announced Wednesday that regulators in Ghana will begin using a federally developed handheld device to screen for fake or diluted versions of two common malaria pills.

More than a third of malaria-fighting pills used in Africa and Asia are either fake or bad quality, according to a study released last year. Rampant drug counterfeiting has undermined efforts to fight the mosquito-borne disease, which causes fever, chills and flu-like illness. Malaria kills more than 660,000 people each year, more than 90 percent of them in Africa.

If the FDA's counterfeit detection device, or CD-3, proves effective in Ghana, the agency hopes to mass produce it on an international scale, which could ultimately reduce counterfeiting around the world.

have long been a problem in developing regions like Africa and Asia, but more fake drugs have been making their way to U.S. pharmacies and hospitals as drug supply chains increasingly stretch across continents. Over 80 percent of the used in U.S. pharmaceuticals are now manufactured overseas, according to one congressional estimate.

"We live in a world where the marketplace is increasingly global, where the of drugs is increasingly vulnerable and we are seeing many more problems with substandard and around the world," said FDA Commissioner Margaret Hamburg, in an interview with The Associated Press. "Unfortunately developing economies are the most burdened by this problem, but we've had serious threats to health in this country as well."

Last year the FDA issued three separate warnings about counterfeit versions of the Roche cancer drug that were sold to U.S. and hospitals. An unknown amount of those fakes was administered to patients. Five years earlier, hundreds of Americans suffered severe allergic reactions and at least 80 died from taking a contaminated blood-thinning ingredient imported from China.

Most counterfeit operations are based in countries with weak regulatory standards, like China, India or Turkey. The fake or substandard drugs can make their way to Africa, Europe or the U.S. through complicated international networks of medical wholesalers and suppliers.

with no malaria-fighting ingredient can lead to deaths when patients rely on them, and those containing some active ingredients—but not enough to cure the disease—are also problematic because they promote resistance that can eventually outsmart medicines and render them useless.

FDA officials say this trend could eventually threaten Americans.

"If anti-malaria drug resistance develops in Ghana and other regions it impacts us because it means that strains of malaria are circulating and anyone can be exposed to them when they're traveling, or when people who are infected come into this country," Hamburg said.

The FDA initiative in Ghana follows the recommendation of a recent report by the Institute of Medicine, which concluded that making detection technology available to developing countries could help curb drug counterfeiting.

Designed by FDA forensic scientists, the CD-3 is a battery-operated device that shoots different wavelengths of light at a product to determine its authenticity. The device, which is about the size of a barcode scanner, compares scanned images to a stored image of the original product, picking up minute differences in packaging, pill color or shape.

The FDA has used the device since 2010 to screen a number of products imported to the U.S. including cosmetics, food, medical devices and cigarettes.

The FDA plans to provide 10 scanners to Ghana, which will be used to screen drugs at five laboratories in towns around the country. These labs are run by the U.S. Pharmacopeial Convention, a nonprofit group that sets quality standards for medicines used in the U.S. and 140 other countries.

Regulators are interested in whether the device can detect fake versions of two widely used malaria pills: Malarone from GlaxoSmithKline, and Coartem from Novartis.

The accuracy of the CD-3's readings will be verified at a national laboratory, where the composition of the drugs will be tested using traditional methods.

Funding for the work comes from a combination of public and private sources, including the U.S. Agency for International Development and the Skoll Global Threats Fund, founded by former eBay President Jeff Skoll.

FDA officials say each CD-3 currently costs about $1,000 to produce. However, regulators expect that the cost will come down considerably after the device is mass produced. The agency said New York manufacturer Corning Inc. has signed an agreement to develop the technology for mass production based on its performance in Ghana.

Explore further: US warns of new fake batch of cancer drug Avastin


Related Stories

US warns of new fake batch of cancer drug Avastin

February 6, 2013
The Food and Drug Administration is warning U.S. doctors about another counterfeit version of the cancer drug Avastin, the third case involving the best-selling Roche drug in the past year.

FDA finds more vials of fake cancer drug

April 4, 2012
(AP) -- The Food and Drug Administration is warning doctors that a second counterfeit version of the best-selling cancer drug Avastin has been found in the U.S., packaged as the Turkish brand of the medication.

Roche warns of counterfeit cancer drug in US

February 14, 2012
(AP) -- The maker of the best-selling cancer drug Avastin is warning doctors and patients about counterfeit vials of the product distributed in the U.S.

Counterfeit drugs becoming big business worldwide

February 16, 2012
(AP) -- The discovery that a fake version of the widely used cancer medicine Avastin is circulating in the United States is raising new fears that the multibillion-dollar drug-counterfeiting trade is increasingly making ...

FDA warns of fake version of ADHD drug Adderall

May 30, 2012
(HealthDay) -- A counterfeit version of the attention-deficit/hyperactivity disorder drug Adderall, sold online, contains the wrong active ingredients, according to the U.S. Food and Drug Administration.

Recommended for you

Sensor-equipped pill raises technological, ethical questions

November 17, 2017
The first drug with a sensor embedded in a pill that alerts doctors when patients have taken their medications was approved by the Food and Drug Administration, raiding issues involving privacy, cost, and whether patients ...

New painkillers reduce overdose risk

November 16, 2017
Scientists on the Florida campus of The Scripps Research Institute (TSRI) have developed new opioid pain relievers that reduce pain on par with morphine but do not slow or stop breathing—the cause of opiate overdose.

Separating side effects could hold key for safer opioids

November 16, 2017
Opioid pain relievers can be extremely effective in relieving pain, but can carry a high risk of addiction and ultimately overdose when breathing is suppressed and stops. Scientists have discovered a way to separate these ...

US regulators approve first digital pill to track patients

November 14, 2017
U.S. regulators have approved the first drug with a sensor that alerts doctors when the medication has been taken, offering a new way of monitoring patients but also raising privacy concerns.

Introduction is different, but top medications for opioid addiction equally effective

November 14, 2017
With opioid addiction officially declared a public health emergency in the U.S., medical intervention to treat the illness is increasingly important in responding to the epidemic. Now, a new study concludes that two of the ...

Drugstore pain pills as effective as opioids in ER patients

November 7, 2017
Emergency rooms are where many patients are first introduced to powerful opioid painkillers, but what if doctors offered over-the-counter pills instead? A new study tested that approach on patients with broken bones and sprains ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.