A Step in the Right Direction
This month, Florida lawmakers unanimously passed legislation increasing penalties for counterfeiting activities, especially those that endanger human lives. While a noteworthy effort, this law reminds me of the old saying, “new, bigger hammers are great—but you still need the carpenters.”
The reason I say this is because Florida’s Anti-Counterfeiting Act does not include resources to hire inspectors, investigators and prosecutors to go after criminals with its stronger anti-counterfeiting provisions.
Transnational criminal organizations are successfully ignoring regulations and violating laws designed to insure the integrity of the many life-saving medicines widely available here in the United States. Unfortunately, the U.S. market will continue to be a tempting target for counterfeiters. If we truly want to stem the illegal trade of fake drugs, let’s make sure there are enough drug regulatory authorities and law enforcement officers to use those new tools.
In the meantime, keep visiting SafeMedicines.org to learn how we can work together to protect the safety of our prescription medicines.
Thomas T. Kubic
Thomas T. Kubic is the Executive Director of the Pharmaceutical Security Institute (PSI), a non-profit association dedicated to protecting the public health by insuring the distribution of pharmaceuticals that are safe and effective. Mr. Kubic currently serves on the World Health Organization’s IMPACT Enforcement Working Group, the Interpol Intellectual Property Crime Action Group, and in an advisory capacity to the Permanent Forum Against International Pharmaceutical Counterfeiting. He is the Treasurer for the Partnership for Safe Medicines. Additionally, he has provided testimony before senior government officials around the world concerning the international nature of counterfeiting and its devastating impact.
Composed of the security directors from 26 pharmaceutical manufacturers with business operations in more than 160 countries, PSI shares information on the counterfeiting of pharmaceuticals and initiates enforcement actions through the appropriate authorities. Under Mr. Kubic’s leadership, PSI was completely reorganized to emphasize information sharing and private-public sector cooperation. Major advances included the development of the PSI Anti-Counterfeiting Strategy and a unique, internationally recognized counterfeit medicines reporting system, the Counterfeit Incident System.
Prior to joining PSI, Mr. Kubic acquired substantial national and international investigative experience during his 30-year career a federal law enforcement executive for the U.S. Federal Bureau of Investigation (FBI). As a FBI Deputy Assistant Director, his innovative programs in both the Laboratory Division and Criminal Investigative Division were recognized throughout the law enforcement community.
Confusing Price With Safety
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.
Take Canada—if drugs are not earmarked for Canadian citizens, they are not subject to the Canadian government's safety regulations. If the goods are "for export only," Canada becomes a post-office box for fake or low-quality drugs from China, India, and other countries notorious for their ineffective and lethal products.
Importing from Britain isn't any safer. Over the past year, Britain's equivalent of the FDA issued half a dozen drug recalls after fake drugs infiltrated its legitimate supply chain. The European Union has identified fake drugs as a critical issue that must be addressed after reports indicated 2.7 million counterfeits detected there in one year.
In addition, the use of the Internet to purchase these drugs is a prescription for disaster. Major regulatory authorities in this country, the E.U., as well as the World Health Organization warn that 50% or more of the products obtained from these sources are fake.
The United States has one of the safest drug supplies in the world because our pharmaceutical supply system is "closed" to importation. Anytime we venture outside of our current closed system, the risk to our health and welfare is real.
The bottom-line is drug importation programs, including the one the Honolulu Star Bulletin endorses, encourage Americans to gamble with their health. Instead of policymakers forcing patients to politically expedient solutions like importation—a policy whose risk of failure will be on the shoulders of vulnerable patient populations such as minorities, seniors, and fixed income patients—policymakers should be focusing on creating programs that provide access to safe medicines. Less expensive does not equal safer. Mandatory low cost/no cost drug programs for brand name and generic companies are a first step for patients up to 400% of poverty. Outreach programs based on these access initiatives to enroll those eligible into public insurance should be created.
In the interim, there are ways of reducing drug costs that don't risk the patients’ health by relying on an Internet seller. Visit SafeMedicines.org to learn about safe ways to get cheaper medicines. Counterfeit drugs are unsafe at any cost.
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.
Partnership for Safe Medicines Issues Statements on Series of Drug Safety Hearings
Recently, the heparin contamination and drug safety in general have taken center stage on Capitol Hill. In the past two weeks, there has been three hearings in the House and one in the Senate examining issues affecting the safety of our prescription medicines.
As part of our commitment to protecting consumers from counterfeit and contraband medicines, the Partnership issued statements to the media and Congress for each hearing about the government’s role in drug safety and suggestions for protecting Americans moving forward.
Although I applaud the members of Congress who initiated these hearings, their findings shouldn’t come as a surprise. Here at the Partnership for Safe Medicines, we have been saying for months that the FDA’s ability to safeguard America’s food and drug supplies is being compromised by numerous challenges and obstacles.
In our statements, we reiterated our call for strict, rigorous regulatory oversight of imported drugs to keep situations such as the recent heparin contamination from repeating in the future. But more importantly, 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.
These hearings were a step in the right direction. But we can’t stop there. It’s essential that Congress and the FDA view the ideas and legislation coming out of these hearings as the beginning of drug safety efforts in our country, not the end.
While the government works to develop a plan to protect Americans, it’s more important than ever before that everyone learns how they can take steps to protect themselves from contraband and potentially counterfeit medicines—because counterfeit drugs are unsafe at any cost. Visit SafeMedicines.org and join us in our stand against counterfeit drugs.
Partnership for Safe Medicines Applauds FDA Reform Bill
WASHINGTON, DC (May 1, 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 Food and Drug Administration (FDA) Globalization Act of 2008 held by the House Committee on Energy and Commerce’s Subcommittee on Health.
Dubbed by supporters as the “FDA reform bill,” the Partnership for Safe Medicines thanks Rep. John Dingell and other members of the Committee for moving this legislation forward. Recent events have demonstrated that reform is necessary, and overdue.
However, we encourage Congress to view this reform bill and other similar legislation as the beginning of drug safety efforts in our country, not the end. The FDA needs authority to destroy unapproved drugs entering our country rather than returning them to the criminals who sent them here in the first place. We need to require Internet pharmacies to be certified so customers can recognize which pharmacies are legitimate and which are rogues selling questionable items. And, we need to stop online pharmacies from selling a controlled substance over the Internet without a valid prescription.
While the government works to develop a plan to protect Americans, 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.