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!

Between a Rock and Hard Place

There's no question that prescription drugs save lives, relieve suffering, and promote the quality of life for those with access to them. There's also no question that, to be helped by these drugs, patients have to be able to afford drugs that are safe and effective.

Unfortunately, current public policy puts patients in a Catch 22 by not effectively addressing either the issues of safe drug availability or affordability. Policymakers focused on drug prices fail to address safety and, on the other hand, those focused on safety fail to address high prices.

According to a recent GAO report and hearings we've talked about in this blog, the FDA isn't able to address the vulnerabilities that allow counterfeits and diverted drugs to enter into the supply chain. Technology focuses on tracking the cardboard packaging of our medicines, not the product. And patients who cannot afford legitimate drugs are increasingly being driven to questionable and unsafe medication sources that expose them to the dangers of counterfeits.

The combination of high prices and limited protections makes the U.S. an attractive market to counterfeiters who can produce fakes at virtually no cost and little risk of being held accountable. This results in huge profits compared to other activities available to the counterfeiter with virtually no chance of being caught.

With growing incidents of counterfeit drugs making their way into the worldwide drug distribution and increasing access to the anonymous and unregulated world of Internet pharmacies, what can be done to help patients avoid being in between a rock and a hard place when it comes to their health?

Some ideas I have include:

• creating a low cost/no cost drug program that segregates needy patients from private markets, with participation by both brand name and generic companies;
• identification and registration of legitimate drug wholesalers;
• banning Internet drug sales unless pharmacies are accredited by the National Association of Boards of Pharmacy;
• prohibiting drug importation;
• directing the Centers for Disease Control and Prevention to create aggressive public and provider education on counterfeit drugs;
• and,
• significantly increase increasing penalties for counterfeiters to fit the crime of cheating the hopes of the sick and vulnerable.

We have a ways to go before we get to these solutions because we need policymakers to think about both price and authenticity when they think of access. But I hope that as more people become aware of our vulnerabilities, the more they'll want policymakers to do something
about it.

In the meantime, consumers can protect themselves and their families by
• Subscribing to the Partnership for Safe Medicines free email alerts. (Link here)
• Downloading our simple SAFEDRUG guide. (Link here)
• If you have to buy drugs online, buying them only from verified online pharmacies. (Link here)

Click here and sign up for the SafeMeds email alerts of government counterfeit drug warnings. We'll talk about other tools in future discussions.

Bryan A. Liang, MD, PhD, JD

Dr. Bryan A. Liang is Executive Director and E. Donald Shapiro Distinguished Professor of Health Law, Institute of Health Law Studies, California Western School of Law; Co-Director and Adjunct Associate Professor of Anesthesiology, San Diego Center for Patient Safety, University of California San Diego School of Medicine; Adjunct Associate Professor of Public Health, Global Emergency Preparedness and Response Program, Graduate School of Public Health at San Diego State University; and Adjunct Professor of Aviation, Western Michigan University College of Aviation.  He also serves as the Vice President for the Partnership for Safe Medicines.

Dr. Liang's research and advocacy focus is patient safety and access to care. He has published and spoken widely on the topic of safety and vulnerability of the drug supply, with more than 300 publications and presentations in domestic and international public and private forums. He received his Bachelor of Science from MIT; PhD from the University of Chicago; MD from Columbia University College of Physicians & Surgeons; and JD from Harvard Law School.

Taking the Cake

In recent weeks, we've heard about a faked FEMA news conference and
planted questions on the presidential campaign trail, but a report
out of China about a fake government website takes the cake.

A story from Reuters earlier this month reports that sellers of
counterfeit drugs have gone as far as setting up a fake website that
pretends to be China's State Food and Drug Administration website.

http://www.reuters.com/article/internetNews/idUSPEK26866520071101

The site, which is accessed through another fake website pretending
to be a research institute, looks very similar to the official
government website and promotes a diabetes medication that doesn't
even exist. The site's purpose is to give the impression that the
drug is an approved medicine.

The anonymity of the Internet allows sellers of counterfeit drugs to
cloak themselves as legitimate-even as a government agency-to
unsuspecting patients.

These clever web designers show we need to be even more vigilant
against online pushers of their fake, harmful products.

One way to do this is to click here and sign up for the SafeMeds email alerts of government counterfeit drug warnings. And, check back for more tips and tools.

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.

Straight from the Horse's Mouth

Yesterday's congressional hearing on the FDA's ability to guarantee the safety of our country's drug supply sounded another alarm that real consumer-protection measures need to be put in place that focus on patient safety.

Let's hope Congress doesn't hit the snooze button again.

It's been 9 years since the Government Accountability Office (GAO) last issued a report to Congress that highlighted the problems the FDA has had in its foreign drug inspection program.

But yesterday, Marcia Cross, director of healthcare for the GAO, painted an even more dismal picture. The GAO report and other testifying witnesses cited example after example of the holes in the FDA's efforts. Since an estimated 80% of the active pharmaceutical ingredients used to make drugs here are imported and another estimated 40% of finished drugs are made abroad, the GAO's findings are especially unsettling. Some highlights:

• Two-thirds of the foreign drug manufacturers subject to FDA inspection may never have been visited by FDA inspectors.
• Foreign drug manufacturers are only inspected once every 13 years - if ever.
• Due to scheduling pressures, foreign inspections can last only 2-3 days, whereas domestic inspections last a week to a month.
• The FDA's databases don't have accurate records as to what companies export drugs into the U.S. or whether they have been inspected.
• The FDA inspectors must provide months of notice to foreign firms that they will be inspected, compared with unannounced inspections in the U.S.
• FDA inspectors aren't provided with translators, leaving them to rely on English-speaking firm employees during their inspections.
• There is no requirement that the FDA conduct foreign inspections with any regularity, compared with every 2 years in the U.S.
• The estimated amount of FDA-responsible imports doubles every 5 years.
• The number of FDA inspectors will drop from 149 in 2002 to only 102 by 2008.

China is the primary country involved in drug manufacture. Rep. John Dingell (D-MI), chairman of the House panel looking into the matter, notes that China alone has 700 firms making drug products for the U.S., but the FDA has the resources to conduct only 20 inspections annually for this country.

But the unregulated Chinese firms are the source of much of the fake medicine throughout the world sold in markets and over the Internet. The World Health Organization estimates that 10% of all drugs are now counterfeit and 50% of drugs sold online are fake.

As supply chains become increasingly global, it's easier than ever for counterfeiters using these foreign materials of questionable quality to penetrate the U.S. market.

I'm encouraged by the congressional focus on this issue. But I hope another nine years doesn't pass before the FDA is given the resources to screen foreign-sourced drugs to ensure patient safety.

In the meantime, consumers must protect themselves and be aware of the risks they take in purchasing medicines from unknown and unverified sources and particularly questionable websites.

One way to do this is to click here and sign up for the SafeMeds email alerts of government counterfeit drug warnings. We'll talk about other tools in future discussions.