Partnership for Safe Medicines Supports Change in Foreign Inspection Process
WASHINGTON, DC (April 29, 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 examination of the events leading up to the distribution of contaminated heparin and Chinese plant inspections held by the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations.
The Partnership for Safe Medicines applauds the Subcommittee for recognizing the importance and urgency of eliminating contaminated drugs. Unfortunately, this recent case of heparin contamination is just one example of the increasingly global problem of counterfeit drugs sold to an unsuspecting public.
Today’s hearing is a step in the right direction. It is important to better understand what went wrong and what solutions are necessary to ensure the safety of our prescription medicines. But we can’t stop there. The FDA needs to open permanent field offices in key exporting countries and it must staff those offices with inspectors and criminal investigators armed with the same authority as their State-side colleagues. The FDA needs to be granted the authority to enter and inspect foreign manufacturing facilities without previous notice.
While we reflect on the events leading up to this tragedy, 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.
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.
Marvin D. Shepherd, PhD
Dr. Marv Shepherd is the Director of the Center for Pharmacoeconomic Studies and Chairman of the Pharmacy Administration Division at the University of Texas at Austin’s College of Pharmacy. He also serves as the President of the Partnership for Safe Medicines.
Among his many research interests, Dr. Shepherd examines the policies related to drug importation and re-importation—especially from Mexico—the use of drug anti-counterfeiting strategies, and techniques for monitoring prescription drug diversion. His research and expertise on drug importation and drug counterfeiting has been featured on CNN News, NPR Radio: First Edition, Newsweek, Wall Street Journal, Money Magazine, Time Magazine, Prevention Magazine, US News and World Report, New York Times, USAToday, Washington Post, plus many other national newspapers, magazines, and television and radio news broadcasts.
He earned a Bachelor of Science in biology from Michigan Technological University, Bachelor of Science in pharmacy from Ferris State University, Master of Science from the University of Rhode Island, and PhD from Purdue University.
Don't Be Fooled by Counterfeit Drugs
April Fool's Day is traditionally celebrated with harmless jokes and pranks among friends. At the end of the day, everyone usually has a good laugh. But as Rick Roberts can tell you, getting fooled by counterfeit drugs is no laughing matter. As he shared in a recent news article, twice, Roberts picked up expensive prescriptions from a reputable pharmacy only to find fake drug.
A few years ago, I helped the Partnership for Safe Medicines develop SAFE DRUG, a checklist guide to help consumers identify and protect against counterfeit medicines. This checklist helps consumers evaluate their medications to make sure they are safe, and provides tips on what to do if they believe there is a problem.
Sample: Request samples of your medications from your physician when first having a medication prescribed in order to compare the appearance, taste, texture and reaction later to medications filled through the doctor's prescription.
Appearance: Compare the prescription medicine you receive with what it is supposed to look like by taking pictures of the original manufacturer's drug and all associated packaging.
Feel: Take note of the prescription drug's taste and any associated feelings once you take it. Is there anything unusual in your body's reaction compared to previous experiences?
Evaluate: Ask your doctor or pharmacist what you should expect to feel and when you should expect to begin feeling relief or improvement.
Doctor: If your drugs do not seem to have the same taste or if you feel different than usual, immediately write down your symptoms and contact your doctor and pharmacist.
Report: If you have any concerns about your drugs, or have confirmed there is a difference in its packaging, labeling or pills, you should immediately contact the pharmacy where you purchased them.
Unavailable: If you confirm that your medicine has been compromised, immediately remove it from your medicine cabinet, mark the packaging with a red pen and put tape around the top of the drug container so that it will be unavailable to you or others in your family.
Gather: Gather all the information you can find related to how you got the counterfeit medication and how long you have been taking it.
We need to be on alert and aware of the real risks associated with online drug sellers and counterfeit medicines. Patients have usually been the first to detect counterfeit medicines, so everyone can help in promoting safe drugs. To learn more about how we can protect ourselves from counterfeit drugs, visit SafeMedicines.org.