GAO Report Weighs in on Federal Efforts Against Counterfeit Products
Protecting the American public against counterfeit drugs is unarguably a daunting task. One of the ways our government combats the sale of unsafe or substandard products—like counterfeit pharmaceuticals—is through the enforcement of intellectual property (IP) laws. So, how are the five key agencies that play a role in IP enforcement faring? Well, it turns out that’s an excellent question that we can’t really answer right now.
According to a March U.S. Government Accountability Office (GAO) report on IP enforcement, the Food and Drug Administration (FDA), Customs and Border Protection, Immigration and Customs Enforcement (ICE), Federal Bureau of Investigation and Department of Justice have not taken key steps to assess their achievements even though their efforts against counterfeit drugs generally increased from 2001-2006.
The good news is that the report offers specific recommendations about how they can improve—such as collected data on their efforts to address IP crimes that affect public health and safety, systematically analyzing their IP enforcement statistics to inform management and resource allocation decisions, and establishing IP-related performance measures or targets to assess their achievements. Also, since counterfeit drugs are an increasingly high priority for the FDA, the agency will permanently assign staff at the new ICE center to help achieve the GAO’s recommendations and improve interagency enforcement efforts.
While government funding and bureaucracy catches up with the extensive needs to combat counterfeit drugs, it’s important we continue to take steps to protect ourselves from counterfeit drugs. The Partnership for Safe Medicines recommends 10 ways you can fight counterfeit drugs:
Follow the news: Learn about what's happening here in the U.S. and other parts of the world with our comprehensive news archive. SafeMedicines.org maintains lists all relevant news stories from around the globe and is great way to see the global dimensions of this problem.
Subscribe to the SafeMeds Weekly News Update: Our free weekly email provides readers with a weekly roundup of what's happening around the world regarding counterfeit drugs, as well as the latest blog entry from our experts.
Learn how to protect your family: Download our simple SAFEDRUG guide and keep your family safe.
Check the list of verified online pharmacies: WHO warns that half of rogue online drugstores sell counterfeits. Go to the VIPPS list to ensure you use reputable Internet pharmacies.
Sign up for the SafeMeds Email Alert System: As part of the FDA's Alert Network, this free service sends official alerts from the FDA and other government agencies around the world to anyone—private citizens, public groups, corporations, associations—when specific counterfeit drug incidents occur.
Test your ability to spot fakes: Can you tell the difference? Check out the FDA archive to see examples of counterfeits.
Become an expert: SafeMedicines.org has a virtual library of testimony, studies, and more.
Use safe channels if you need help paying for medicines: The Partnership for Prescription Assistance (PPA) is a clearinghouse of information that is a single point of access to more than 475 public and private patient assistance programs for anyone who cannot afford to fill their prescriptions and get medicine they need.
Join the Partnership for Safe Medicines: Help us protect consumers from counterfeit or contraband medicines.
Learn how to spot rogue websites. Do you want to help put fight counterfeiters? Become a virtual volunteer. Write us for more information.
Posted by safemedicines2 at 09:30 AM
Consumer Protection Group Issues Statement About FDA's Ability to Enforce Safety Regulations
WASHINGTON, DC (April 24, 2008) – The Partnership for Safe Medicines, a group of organizations and individuals dedicated to protect consumers from counterfeit medicines, issued the following statement regarding today's hearing on the Food and Drug Administration’s (FDA) ability to enforce safety regulations held by the Senate Committee on Health, Education, Labor, and Pensions.
The Partnership for Safe Medicines applauds the Committee for recognizing that the FDA’s ability to safeguard America’s food and drug supplies is being compromised by numerous challenges and obstacles. Unfortunately, this recent case of heparin contamination is just one example of the increasingly global problem of counterfeit drugs sold to an unsuspecting public.
We have seen time and time again that unscrupulous suppliers will not hesitate to use foreign, even toxic, materials in a drug's raw materials if it means more money. And it's easier than ever for counterfeiters to use materials of questionable quality to penetrate the U.S. market since criminals are becoming more organized and inventive.
The United States needs to a leader in the global fight against fake drugs. We need to give the FDA all the tools it truly needs to fix the problems, including a dramatic, and sustained, funding increase. We need to work with governments around the world to adopt a tougher stand against the perpetrators of counterfeit medicines that reflects the gravity of their offenses. And we need to send a message to these criminals that we will not tolerate activities to compromise public health.
The Partnership encourages everyone to learn how they can take steps to protect themselves from contraband and potentially counterfeit medicines—because counterfeit drugs are unsafe at any cost.
About the Partnerships for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. For more information, please visit SafeMedicines.org.
Partnership for Safe Medicines Issues Statement About FDA Foreign Drug Inspection Program
WASHINGTON, DC (April 22, 2008) – The Partnership for Safe Medicines, a group of organizations and individuals dedicated to protect consumers from counterfeit medicines, issued the following statement regarding today's hearing on the Food and Drug Administration’s (FDA) efforts to inspect foreign drug plants making products for the U.S. market held by the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations.
The Partnership for Safe Medicines echoes the concerns expressed by Congressmen Dingell, Barton, Stupak and Shimkus about the state of the FDA’s foreign drug inspection program. There is a strong need for strict, rigorous regulatory oversight of imported drugs to keep situations such as the recent heparin contamination from repeating in the future. However, progress in the fight against counterfeit and contaminated medications is unforeseeable unless we give the FDA all the tools it truly needs to fix the problems.
The FDA needs a dramatic, and sustained, increase in funding in order to properly inspect the foreign manufacturing facilities producing the active pharmaceutical ingredient (API) in America’s drugs. It needs the resources to open permanent field offices in China, India and other key exporting countries staffed with both inspectors and criminal investigators.
This Subcommittee hearing addresses key issues core to our mission – to protect consumers from contraband and counterfeit medicines. The Partnership continues to encourage consumers to learn how to protect themselves from potentially dangerous medicines while Congress and the FDA work together to improve its capacity to properly regulate pharmaceutical importation.
About the Partnerships for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. For more information, please visit SafeMedicines.org.
Heparin Update: 62 Suspected U.S. Fatalities, 2 Upcoming Hearings
Marv Shepherd, PhD
The heparin fallout continues. As an update to our March 13 post, the Food and Drug Administration (FDA) now reports 62, not 19, suspicious deaths in the United States linked to the blood thinner heparin, most of which occurred in December, January and February. According to an article in the New York Times, investigations continue into whether the deaths were caused by the Chinese contaminant.
Recognizing the importance and urgency of eliminating contaminated drugs, the Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations will hold two hearings in the coming weeks on this issue. The first hearing, tentatively scheduled for Tuesday, April 22 at 11 a.m., will ask FDA Commissioner Andrew von Eschenbach to explain how to address the many concerns raised by the Committee regarding FDA’s efforts to inspect foreign drug plants making products for the U.S. market. The second hearing, tentatively scheduled for Tuesday, April 29 at 10 a.m., will examine the events leading up to the distribution of a contaminated batch of heparin imported from China.
The Partnership for Safe Medications applauds the efforts of Committee Chairman John D. Dingell, Committee Ranking Member Joe Barton, Subcommittee Chairman Bart Stupak and Subcommittee Ranking Member John Shimkus in arranging these hearings. Every step taken to ensure the safety of consumers is an important one.
Contaminated heparin is just one example of the increasingly global problem of counterfeit and contraband medications sold to an unknowing public. It is important to educate yourself on this topic and SafeMedicines.org has many resources available on how to keep your family safe, verifying online pharmacies are legitimate, how to spot fake drugs and the safe channels available to pay for prescription medications. Don’t become a victim—or a statistic—of counterfeit drugs.
Illicit: The Dark Trade
The Partnership for Safe Medicines urges you to watch the groundbreaking film, Illicit: The Dark Trade, premiering nationwide tonight on PBS. Based on the best-selling book by Dr. Moisés Naím, Illicit exposes the staggering impact counterfeiting and piracy has on the world economy, jobs, and consumer health and safety.
Watch the Trailer
Illicit reveals the criminal networks behind the multibillion dollar global trade of illicit goods (which includes everything from auto parts and pharmaceuticals to handbags and DVDs) and the dire consequences of their growing industry—money laundering, political corruption, and the subversion of entire governments.
Check your local listing times and set your TiVo’s so you don’t miss this important documentary.
Federal Efforts to Combat Fake Meds
Marv Shepherd, PhD
Counterfeit drugs, tainted medicines, rogue online pharmacies – inarguably a growing problem around the world. But what can our federal government do to help protect us here in the United States?
One of our government’s best weapons in the battle against counterfeit drugs is the Food and Drug Administration’s (FDA) Alert Network, a coalition of health professional and consumer groups. The Alert Network disseminates alert messages about counterfeit drug incidents in the U.S. and develops educational information about the roles and responsibilities consumers and professionals should play to identify and report counterfeit drugs.
And recently, it played a role in helping indict Georgios Xydeas, a Greek national, for selling counterfeit, misbranded and unapproved prescription drugs to online pharmacies and undercover agents.
In February 2007, the FDA issued an alert saying some Internet pharmacy customers were receiving a powerful anti-psychotic drug identified as Haloperidol, the active pharmaceutical ingredient found in Haldol, instead of the medication they ordered. The misbranded drugs were shipped from Greece and further investigation led agents to Xydeas.
Although the foreign-based aspect of this crime makes U.S. investigation and prosecution especially difficult (this single counterfeit drug case was investigated for three years by agents from the U.S. Department of Homeland Security’s Immigration and Customs Enforcement, the Food and Drug Administration’s Office of Criminal Investigations, DOJ’s U.S. Attorney’s Office and the Chinese government, with support from the U.S. State Department and Panamanian officials and assistance from the Eli Lilly Pharmaceutical Co., the Sanofi-Aventis Pharmaceutical Co., the British Medicines and Health Care Regulatory Agency), Xydeas is facing 43 criminal counts for his role as a suppler of these misbranded and counterfeit drugs from China.
As counterfeiters have grown more sophisticated and set-up deceptive online pharmacies to con patients, we can use some of that same technology to fight back against fake drugs. I’m proud the Partnership for Safe Medicines’ SafeMeds Email Alert System is part of the FDA’s Alert Network. Our email alert system sends official alerts from the FDA and other government agencies around the world to anyone—private citizens, public groups, corporations, associations. To learn more about the SafeMeds Email Alert System and sign up for this free service, please visit SafeMedicines.org.
Regulating Online Pharmacies
Bryan A. Liang, MD, PhD, JD
According to some sources, there are at least 1,000 Web sites selling prescription drugs. Of course, not all of which are legitimate. Considering the sheer number of hits an Internet search for "online pharmacy" returns, it's not surprising that the U.S. Senate has put the Online Pharmacy Consumer Protection Act of 2007 on its legislative calendar.
One provision in the Act will prohibit an online pharmacy from selling a controlled substance over the Internet without a valid prescription. This is not an isolated concern. In fact, recently a Utah couple was in the news for their role in an international counterfeit drug operation in which they received and distributed shipments of hundreds of drugs, sometimes thousands of tablets, without a license or doctor's supervision.
As I've noted elsewhere, by confronting the safety issues associated with online drug access, requiring a prescription is step in the right direction. But it needs to go much further. It should require online pharmacies to be certified so customers can recognize which pharmacies are legitimate.
Stories of people who've died after purchasing controlled substances through online pharmacies are tragic. For example, Ryan Haight, a straight-A, talented high school scholar and athlete died because of an overdose of Vicodin, a powerful painkiller that he'd purchased without a prescription through an unregulated Internet seller.
Unfortunately, online drug peddlers prey upon an increasing demand: the National Survey of Drug Use and Health found that 6 million Americans aged 12 or older had used prescription psychotherapeutic drugs nonmedically in the previous month, and 3.1 million had abused OxyContin in their short lives. The bulk of new abusers are in the 12- to 17-year-old age group.
Further, beyond selling drugs of abuse to children, unregulated online pharmacies also maim and injure patients by passing off fakes.
Patients who access drugs through the Internet, who often represent some of the most vulnerable patients including the elderly and minorities, don't know they are not getting the real thing because many diseases are "silent."
Drugs treating high blood pressure, elevated cholesterol, cancer, and other illnesses don't provide immediate or obvious clinical changes after being taken.
Unregulated online sellers represent a lose-lose situation—patients getting the drugs of abuse they want; and patients not getting the drugs of treatment they need.
However, mandating prescriptions alone is not enough. Unscrupulous online businesses will sell whatever to whomever, as long as they are paid. Just as they've embraced counterfeit drugs, they'll also sell fake prescriptions.
Regulating these pharmacies should include verification that consumers have a valid prescription. But these sellers should also be licensed in the state where they sell drugs just like normal pharmacies, and be subject to rigorous oversight standards, such as the VIPPS program--the Verified Internet Pharmacy Practice Site accreditation program created by the National Association of Boards of Pharmacy.
The idea of ensuring that pharmacies verify prescriptions is a good one. But it is only a start. Oversight must include assurances that they are legitimate, have a license, and verify the need for the medications they dispense.
For more information about buying safely online, go to SafeMedicines.org.
Safe Alternatives for Reducing Healthcare Spending
Bryan A. Liang, MD, PhD, JD
Healthcare spending and prices are on the rise—again. The Centers for Medicare and Medicaid Services estimates that overall healthcare spending in America will reach $4.3 trillion annually by 2017. Given that healthcare costs are increasing at nearly three times the rate of inflation, it's no wonder Americans are seeking ways to keep their healthcare costs low.
Some are turning to the Internet, where thousands of Web sites promise big savings on prescription drugs. But Internet-based sales of pharmaceuticals are a major source of counterfeit medicines in industrial countries according to the World Health Organization. In fact, again according to WHO, Internet "pharmacies" ship fakes in more than 50 percent of cases.
Patients don't have to turn to questionable online sellers to get the medications they need. The Partnership for Prescription Assistance (PPA) is a safe alternative for patients who cannot afford to fill their prescriptions and get medicine they need.
The PPA is a clearinghouse of information that is a single point of access to more than 475 public and private patient assistance programs. The program offers language assistance and can provide information in over 100 different languages. Patients only need to answer a few short eligibility questions, which they can do online or by phone (1-888-477-2669) to find out if they quality for assistance programs.
It's always a good idea to save money - but patient safety should never be sacrificed. Being left untreated, injured, or killed is not a good tradeoff for purchasing from risky Internet sellers.
Meeting of the Minds
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.
Meeting of the Minds
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.
Today's Subcommittee Hearing
Today the House Appropriation's Committee's Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a hearing on drug safety. You can view the Partnership for Safe Medicines' thoughts on the matter here.
Scary Stuff
A sobering new report from the United Nations, "Counterfeiting: a global spread, a global threat," was released last Friday. It details the growing enterprise of counterfeiting and its allure to organized criminals.
Why? "Counterfeiting has become fertile ground for organized crime because the syndicates realize they can make great profit at little risk," said Sandro Calvani, the director of the U.N. Interregional Crime and Justice Research Institute (UNICRI), which wrote the report.
The extensive report addresses all varieties of counterfeiting, with counterfeit medicines, "products which may cause serious damage to the health and safety of consumers," as a prominent part. (To read the report and an executive summary, go to http://www.unicri.it/wwd/emerging_crimes/counterfeiting.php)
Of particular interest is the section on "The Scale of the Problem."
In this section¸ the report looks at the attraction and impact of counterfeit drugs in highly developed versus developing countries, and the strategies adopted by counterfeiters. In developed countries, the report notes, counterfeiters focus on drugs with the highest market share and profitability; whereas in developing countries, they focus on the constant demand for drugs that combat epidemics and serious diseases, such as malaria and HIV.
Seemingly out of a horror film plot - though sadly not - the report also raises a very scary point about the large presence of counterfeit drugs in developing countries (as high as 10-30% in Africa, Asia and parts of Latin America according to the WHO). According to the report, the long-term effects of patients unknowingly taking counterfeit medicines to combat serious diseases could actually "promote the development of new strains of viruses, parasites and bacteria ... for example in the case of malaria or HIV."
The UNICRI report calls for an improved global response to counterfeiting that goes beyond just punishing offenders on the basis of economic damages or a violation of public faith (the approach for prosecuting counterfeiting items such as luxury goods). It outlines a series of proposals based on the need to punish counterfeiters that takes into account the problem's complex nature and the severity of the offenses possible.
I hope our and other governments will take this report seriously and work together to combat this growing problem. If not, we can be certain that organized crime will continue counterfeiting, counterfeit drugs will make their way into legitimate supply chains and our health will be further jeopardized.
We must work together globally to address this scourge; otherwise we fate our children and their children to deal with a problem that will only grow worse and more difficult to solve.
As always, our job today is to stay vigilant and protect ourselves and our families. Remember, we are the last barrier to harm!
- SAFE DRUG (click here)checklist to learn how to avoid, deter, and report suspected counterfeit drugs.
- SAFEMEDS EMAIL ALERT SYSTEM (click here), which broadcasts FDA Counterfeit Alert Network notices as soon as they come out.
- Verified Internet Pharmacy Practice Sites (click here), that are accredited by The National Association of Boards of Pharmacy's (NABP) as legitimate pharmacies.
The Bahamas - Not Just a Vacation Spot Anymore
The ongoing New York Times series "A Toxic Pipeline" continues to shed light on the complex routes that counterfeit drugs take before being sold by Internet pharmacies, many of which purport legitimacy with Canadian, British or Australian websites.
Today, the series (http://www.nytimes.com/2007/12/17/world/middleeast...) focused on the "complex supply chain of fake drugs" that starts with China, goes through the United Arab Emirates, then the Bahamas and finally to Britain before making its way to U.S. buyers. This roundabout path is used to fool the customs officials and buyers into thinking that their drugs are coming from a "trusted" source.
This chilling expose shows this couldn't be further from the truth. These drugs are made in China. Unscrupulous sellers transfer them between "Free Trade Zones" in the Middle East that have little regulation or accountability so as to hide their origins. They are shipped to the UK en route to the Bahamas for Internet sales. Once ordered by US customers, they are shipped back to the UK for a British stamp to make them appear "legitimate."
Counterfeiters are willing to go these extra miles because the profits are worth it. And vulnerable patients are the prime targets for these creatures that sell through these questionable and dangerous sources.
Health officials worldwide are trying to better ensure the safety of our prescription drugs. The reality, however, is that coordinating worldwide regulatory bodies to effectively address this growing challenge that will not happen soon enough for those already injured by these products or those who will be.
And so our job is to stay vigilant and protect ourselves and our families. Remember, we are the last barrier to harm!
To help you, check out the tools on this website including the:
- SAFE DRUG checklist to learn how to avoid, deter, and report suspected counterfeit drugs.
- SAFEMEDS EMAIL ALERT SYSTEM, which broadcasts FDA Counterfeit Alert Network notices as soon as they come out.
- Verified Internet Pharmacy Practice Sites (click here), that are accredited by The National Association of Boards of Pharmacy's (NABP) as legitimate pharmacies.
IMPACT-ing Prescription Drug Safety
In February 2006, the World Health Organization launched the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) to build coordinated efforts between countries to address the great deal of harm from fake medicines around the globe.
This is no minimal bureaucratic effort. IMPACT is a partnership of all the major stakeholders: international organizations, non-governmental advocacy and patient groups, law enforcement, pharmaceutical manufacturers and their trade associations, as well as government drug regulatory authorities.
This week, IMPACT members are meeting in Lisbon to review findings and recommendations for how to turn the tide on the growing dangers of counterfeit drugs. These are available in a draft background paper for discussion and finalization of principles that could serve legislation for all WHO member states. The draft paper, "Draft Principles and Elements for National Legislation against Counterfeit Medical Products" can be found at:
http://www.who.int/impact/events/Principles_ElementsforNationalLegisl...
An important recommendation of the draft report is a call for governments around the world to adopt a tougher stand against the perpetrators of counterfeit medicines that reflects the "gravity" of their offenses. This includes introducing severe criminal sanctions against its perpetrators regardless of evidence of specific harm caused to others-something I've called for in the past, given the potentially dire consequences - including death - of consumers unknowingly using counterfeit drugs.
I will be keeping a close eye on the outcome of this week's meeting and hope that members of IMPACT adopt these and other patient safety oriented recommendations.
In the meantime, my old call: remember to protect yourself and your family! You are the last barrier to harm!
Tools on this website can help you:
- 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.
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.
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.