CDC | FDA Voice

By: Deborah M. Autor, Esq. and Melinda K. Plaisier

Deborah M. Autor

Somewhere right now, malaria patients facing a life-threatening illness are being treated with counterfeit or substandard anti-malarial drugs, including falsified products, that threaten their recovery and can contribute to drug resistance. We are proud to announce the Food and Drug Administration’s launch of a partnership that will use a clever, innovative tool invented by FDA scientists to quickly and cheaply test suspect counterfeit or substandard anti-malarial drugs, including falsified products. The partnership will test the effectiveness of this hand-held, battery-operated tool, called Counterfeit Detection Device, Version 3, or, simply, CD-3. It will be deployed first in Ghana and then, after data is collected, in a second testing region.

This effort, which we hope will expand worldwide, is aimed at catching products that both deprive people of critical, life-saving help and add to disease burden because substandard doses can lead to drug resistant strains of the malarial parasite.

Melinda K. Plaisier

Malaria kills more than a 660,000 people each year, mostly children. It is most prevalent in Africa and Southeast Asia. In Southeast Asia and sub-Saharan Africa, more than a third of anti-malaria drugs are counterfeit or substandard, and a recent review indicates that number might be as high as two-thirds.

CD-3 is the brainchild of FDA scientists Nicola Ranieri and Mark Witkowski of FDA’s Forensic Chemistry Center (FCC), who recognized that since substances have unique responses to light, they might be able to develop a portable tool that could identify counterfeits on the spot, even in remote locations. As the initial tool has undergone a number of revisions, capabilities have been added, applications have been developed, and CD-3 has become a more powerful tool. From prototypes, scientists at FCC built a number of CD-3s, which are currently being used in the U.S. at ports and international mail centers, and during criminal investigations at the FCC.

To gear up for a global deployment strategy, FDA has separately signed a letter of intent with Corning, Inc., to optimize the tool, using information gathered from the studies in Ghana and the second testing region. FDA is hopeful that the improved tool will eventually be manufactured for use around the world.

The CD-3 tool contains a library of information about authentic drugs and the packaging they come in. It allows the user to compare authentic images of a product with the suspect product, instantaneously showing clear differences between suspect and authentic products that would not have been clear to the naked eye.

The Unites States Pharmacopeia, with funding through the U.S. Agency for International Development and the President’s Malaria Initiative, currently conducts drug surveillance programs at the test sites where CD-3 will be tested. FDA is providing ten CD-3s in the first test, and technical support will be provided by the Centers for Disease Control and Prevention and the National Institutes of Health. The non-profit Skoll Global Threats Fund is providing additional funding for the initial testing in Ghana.

We are thrilled about these developments and proud of this important, multi-sector collaboration and our highly dedicated staff who are making it possible. It is a credit to them, to our partners, and to all of FDA, that they are able to bring this innovative solution to such a significant global public health problem.

To learn more watch the CD-3 video below and read the Consumer Update: FDA Invention Fights Counterfeit Malaria Drugs

Deborah M. Autor, Esq., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Melinda K. Plaisier is FDA’s Acting Associate Commissioner for Regulatory Affairs

By: Maureen Hess, MPH, RD

You probably think about influenza once a year — during the winter months when flu season rolls in as it does every year. But, for FDA, it’s a year-round initiative; we are on the front lines of making sure there is an adequate supply of safe and effective vaccine every year. And even though the current flu season is just getting started, we are already making preparations for next year.

Woman getting flu shot Vaccination is the single best way to prevent influenza. Influenza is a contagious respiratory disease caused by a number of different influenza viruses, infecting the nose, throat and lungs. Even if you are healthy, you can pass the influenza virus to someone else one day before symptoms begin, and, you can continue to infect others up to five days after getting sick. Therefore, it’s possible for a healthy person to unknowingly spread the virus.

Preparing for influenza season each year is a time-critical, highly orchestrated, collaborative effort by FDA, the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), vaccine manufacturers, and the public health community.

FDA is at the center of the process. Working with the WHO and CDC to review disease surveillance and laboratory data, and with the input of our advisory committee, we select the three influenza strains for the vaccine that will be made available in the United States. Once the strains have been selected, work continues to get vaccine manufactured and distributed well before influenza season starts. We inspect the manufacturing facilities and we prepare and provide the reagents used by vaccine manufacturers to verify the vaccine’s identity and strength.

FDA also evaluates each manufacturer’s vaccine each year for approval and conducts lot release, that is, we perform certain tests and review the results of the manufacturers’ tests on the vaccines prior to vaccine distribution. And, we continue to monitor the safety of the vaccines once they are distributed and used to vaccinate the public. The manufacturing demands are tremendous, especially since a new vaccine must be manufactured each year. And, this new vaccine contains not just one but three new vaccine components each year, specifically, the three strains of influenza virus within the seasonal vaccine: one influenza A (H3N2) virus, one influenza A (H1N1) virus, and one influenza B virus.

Why is FDA focused on influenza? Influenza seasons are unpredictable and present a serious public health issue. Vaccination is one of the most important ways to prevent influenza. Influenza can cause various symptoms, which may include fever, cough, sore throat, headache, body aches and chills and tiredness. And the disease can range from mild to serious: over a 30 year period between 1976 and 2006, estimates of seasonal influenza-associated deaths range from a low of about 3,000 to a high of about 49,000 people.

Vaccines to prevent seasonal influenza have a long and successful track record of safety and effectiveness in the United States. The vaccine won’t give you the flu, and not only should it protect you from getting sick, it can also make your illness milder if you are exposed to a different influenza virus strain that’s not included in the vaccine.

Have you gotten your flu vaccine? It’s not too late!

Maureen Hess, MPH, RD, is Health Science Advisor, Office of Vaccines Research and Review, in FDA’s Center for Biologics Evaluation and & Research

FDA Voice

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