Importation

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.

Collaborative efforts took place early last week when international business leaders met with the United States Trade Representative, World Customs Organization and World Intellectual Property Organization, urging them to swiftly complete the Anti-Counterfeiting Trade Agreement (ACTA). This global agreement would be the first of its kind for battling counterfeit drugs.

And as the New York Sun article points out, ACTA takes special aim at “combating what has become the most lucrative type of piracy around the world: fake prescription drugs.” This follows a recent report that intellectual property crimes almost doubled in 2007 compared to 2005, according to Department of Commerce officials.

The Sun’s article highlights how the widespread the problem of counterfeit drugs really is. For example, as of last December, authorities have discovered counterfeit versions of Pfizer drugs in at least 75 countries. And even more disturbing, seven of those counterfeits drug have turned up in legitimate supply chains in at least 25 countries.

This information shows that we need stronger enforcement measures and international cooperation if we are to ever combat the serious dangers these "products" pose to consumer safety. As global leaders work on enacting the ACTA, we need to remember that we are last barrier to harm -- so remember to protect yourself and your family.

As a first step, consumers can sign up for the SAFEMEDS EMAIL ALERT SYSTEM, which broadcasts FDA Counterfeit Alert Network notices as soon as they come out.

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.

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.

Overall, the MHRA's strategy sets out to tackle four major problems of counterfeiting in the UK:

• the availability of counterfeit medicines (and medical devices) there;
• the fact that the UK is an attractive market for counterfeiters because of the high prices of drugs, a large market, and very complex supply chain;
• the need to raise awareness of the counterfeit drug threat to the public and stakeholders; and,
• the problem of counterfeiters using the UK as a transit point and distribution hub.

So it's clear that the UK isn't going to tolerate counterfeiters, typically from Asia, using the UK as "cover" for sending fake drugs ordered online from the U.S. Part of its strategy is looking to increase criminal prosecutions in these cases.

I applaud the MHRA for drawing the line in the sand and effectively telling counterfeiters "we're not going to take it". I congratulate the British public for having a drug regulatory authority that is actively addressing this important patient safety issue.

Unfortunately, the problems with counterfeiting aren't confined to the UK. Many of the problems noted by the MHRA are common in the U.S. as well.

As I've noted before, patients are the last barrier to harm. Here in the U.S., the FDA has had a counterfeit-watch program for a couple of years now, whereby consumers are encouraged to report suspicions of counterfeit drugs. To do so, consumers can call MedWatch at 1-800-322-1088. Let the FDA know if you suspect fakes! The worst you can be is wrong; the best you can do is save lives.

Other ways that you can protect yourself include tools you can find on this website:

• Download the SAFE DRUG checklist to learn how to avoid, deter, and report suspected counterfeit drugs.
• Sign up for the SAFEMEDS EMAIL ALERT SYSTEM, which broadcasts FDA Counterfeit Alert Network notices as soon as they come out.
• If you do buy drugs online, only use Verified Internet Pharmacy Practice Sites (click here), that are accredited by The National Association of Boards of Pharmacy's (NABP) as legitimate pharmacies.

Remember protect yourself and your family! You are the last barrier to harm!

When is enough, enough?

The latest recall of yet another Chinese-made toy keeps the dangers of counterfeits front and center for parents, consumer watch groups and legislators. This time, 4.2 million toys were pulled from shelves in U.S. stores and Internet sites following a link made between the toy and 2 children who had fallen seriously ill after ingesting it.

The immediate response to protect our children's safety is impressive and necessary. With each incident, we become more vigilant about the risks of imported toys, particularly from China in recent times. Unfortunately, it's impossible to know which toys pose a threat until tragedy occurs.

This additional example of problems with imported products-toys to toothpaste-seems to get more attention than the problem of counterfeit drugs from suspect sources such as China, the Internet, and over-the-border. Yet dangerous and tragic results from counterfeit drugs we swallow and inject have occurred. We need much more of a public uproar to ensure that we and our families are protected from this plague.

This isn't about someone else. It's about our neighbors, friends, and loved ones. And because it's big business with virtually no risk or oversight-as we heard at Congressional hearings last week-the industry is only getting larger. The U.S.-based Center for Medicines in the Public Interest estimates counterfeit drug sales will increase to $75 billion by 2010, a more than 90 per cent increase from 2005.

How many more counterfeit drug incidents will it take to get the same kind of response from authorities that we've seen with counterfeit toys?

No matter what, consumers can and do need to take measures to protect themselves and their families. We are always the last barrier to harm.

Be informed. One way is to click here to sign up for the SafeMeds email alerts. This system will provide you with all government counterfeit drug warnings right in your inbox (and no prescription drug spam!).

Until next time, be safe.