Congress Joins the Battle Against Counterfeit Drugs

Signed into law last week, the PRO-IP Act is the most comprehensive IP enforcement legislation adopted by Congress in years. Not only does it increase the penalties for counterfeiting offenses that endanger public health and safety, it provides much-needed resources to at federal, state and local law enforcement levels. Additionally, the law creates the position…

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Counterfeit Drugs and Baby Formula

Marv Shepherd, PhD

Four infants are dead and more than 54,000 children in China have suffered from kidney stones and kidney failure this past year as a result of baby formula and powdered milk tainted with melamine, an industrial chemical used to make plastics, glue and is found in pesticides.  The toxin found its way into the milk products from more than 30 Chinese companies because of its ability to make the milk appear high in protein. 

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Politics and Counterfeit Drugs

Currently, the United States has one of the safest drug supplies in the world because its pharmaceutical supply system is “closed” to importation. Once a drug is outside the strictly regulated distribution channel, there is no guarantee of its authenticity, effectiveness, or safety. We know from the recent incident in China of the deliberately contaminated…

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Defining the Problem

Bryan A.  Liang, MD, PhD, JD

Often understanding a problem begins with a definition.  The World Health Assembly, the decision-making body of the World Health Organization (WHO), meets each May to discuss public health issues and determine future WHO policies.  This year, WHO's constituted International Medical Products Anti-Counterfeiting Taskforce (IMPACT) introduced a resolution to update WHO's definition of a counterfeit medicine.  IMPACT proposed changing the definition from "deliberately and fraudulently" mislabeling a medicine's identity and source to the "false representation" of a medical product's identity, history or source.

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Principles for Drug Safety

If Congress and the FDA truly want to avoid another deadly incident of failed drug safety, our policy makers must take this opportunity to address the other vulnerabilities threatening the safety of our prescription drugs. The Partnership for Safe Medicines has developed three core principles to support quality assurance programs and establish a drug distribution…

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Confusing Price With Safety

Bryan A. Liang, MD, PhD, JD

We all try to do our best, but even those in public service don't always get it right.  This seems to be the case when it comes to drug importation.  Supporters think that simply because drugs are purchased from "safe" countries as Canada and Britain, they are actually made there and are subject to strict health regulations and oversight.  But this is a dangerous misconception.

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Meeting of the Minds

Bryan A. Liang, MD, PhD, JD

It's an interesting phenomenon.  We have general agreement that fake medicines put people in harms way – but an increasing number of these drugs are entering the world's markets.  In fact, the World Health Organization estimates that up to 10 percent of all medicines are counterfeits, rising to 25 percent in some countries.

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They’re Not Going to Take It

Recognizing the growing threat of the availability of counterfeit drugs worldwide, the Medicines and Healthcare Regulatory Products Agency (MHRA) – Britain's version of the FDA – last week published its first Anti-Counterfeiting Strategy. The strategy sets out the MHRA's approach to combating this threat for the next three years, including the launch of a new 24-hour hotline for reporting suspected counterfeit medicines and devices.

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