All Posts Tagged With: "counterfeit drugs"
Counterfeit drugs continue to threaten lives in developing countries
Getting prescription medication into developing countries is hard enough. But what if the drugs that actually make it there don’t work? Or worse, they cause further harm?
The World Health Organization (WHO) estimated three years ago that nearly one in four pharmaceutical drugs sold in the developing world is counterfeit, the New York Times reported this week. And recent discoveries suggest the war on fake drugs shows no sign of abating, as the pharmaceutical forgers wield increasingly sophisticated weaponry.
“The counterfeit drug business has become increasingly attractive for criminal syndicates,” according to the Times. “The profit potential is vast, yet punishment for those caught is typically much less severe than for illegal drugs like cocaine, law enforcement officials say.”
The more phony pills lining drug store shelves, the more treatment failures patients suffer. Not all are completely inert, either: drugs have been found to include low levels of active ingredients—too low to be effective, yet high enough to trigger drug resistance and to be detected in screening tests for fakes. Some can also contain ingredients used for irrelevant conditions. One purported antimalarial appeared to contain sildenafil, the main ingredient in the impotence drug Viagra.
Read the rest of this article on counterfeit drugs in developing countries.
Congress on the Right Road to Stop Drug Counterfeiters
Bryan A. Liang, MD, PhD, JD
Earlier this year, Reps. John D. Dingell (D-MI 15), Frank Pallone, Jr. (D-NJ 06) and Bart Stupak (D-MI 01) introduced the Food and Drug Administration Globalization Act of 2009 (H.R.759). This legislation indicates that Congress is beginning an important journey to address several real threats that substandard and counterfeit drugs pose to the pharmaceutical supply chain.
The bill incorporates a number of the Partnership for Safe Medicines’ Principles for Drug Safety and also introduces a Quality Risk Management Plan, which outlines specifications for safeguarding drug and medical devices, including:
- An assessment of companies contracting with a person to supply raw materials or ingredients;
- Monitoring and review through periodic on-site audits of the production facility’s conditions its controls and practices;
- Monitoring incoming materials; and
- Implementation of systems to ensure the appropriate specifications, test methods and verification of the drug ingredients’ identity, quality, strength, and purity.
The proposal also asks for authority to implement stronger enforcement tools, including:
- Destruction of counterfeit imports if they pose a risk of injury or death;
- Monetary and criminal penalties against offenders;
- Mandating the FDA to recall and detain unsafe drugs; and
- Allowing the FDA to subpoena records related to possible violations.
Read the rest of this article on counterfeit drugs on safemedicines.org.
To Import or Not To Import Pharmaceutical Drugs
That is the question that many of our lawmakers are asking. Senators Dorgan (D-ND), Snowe (R-ME), McCain (R-AZ) and Stabenow (D-MI) brought that question to the forefront when they introduced the "Pharmaceutical Market Access and Drug Safety Act of 2009" (S. 525 ) in March. Currently waiting to be placed on the Senate calendar, the bill would allow for prescription drug importation.
While a good-intentioned idea, the Partnership for Safe Medicines (PSM) believes that "Pharmaceutical Market Access and Drug Safety Act of 2009" will undermine nearly two decades of drug safety policy. Throughout the past 16 years and under two administrations, no HHS Secretary—Democrat or Republican—has certified a drug importation plans—a clear indication of the extreme safety concerns associated with drug importation and the challenges with ensuring safety of the globalized drug supply.
Unfortunately, this legislation simply does not recognize the increasing vulnerability of the international supply chain. In fact, it would allow importation from several countries that have had recent problems with counterfeit drugs in their own country. In the past three months alone, the Medicines Health products Regulatory Agency (MHRA)—the British equivalent of the U.S. Food and Drug Administration (FDA)—has issued two recalls for counterfeit insulin pens and inhalers . The European Union’s 2007 pharmaceutical counterfeiting data shows that almost 40 percent of fake medicines seized by the E.U. originated in Switzerland. And according to the Pharmaceutical Security Institute (a member of the Partnership for Safe Medicines), last year, there were 104 reported incidents of counterfeit medicines in Japan, while Germany and Austria were in the top 10 countries where counterfeit drugs were most frequently seized or discovered.
Any time consumers are subject to drugs from outside of the U.S.’s currently closed drug supply chain, there is a very real risk to their health and welfare. Foreign pharmacies are not subject to the FDA’s jurisdiction and the exporting countries’ equivalents of the FDA are not going to spend their limited resources scrutinizing drugs not earmarked for their citizens. It is both impractical and not their legal responsibility. Additionally, criminals continually use European parallel importation and trade laws to slip counterfeit drugs into the legitimate supply chains of member countries that allow it, such as the United Kingdom. Finally, there is no evidence that drug importation provides any real savings according to the Congressional Budget Office and independent academic analysis.
Read the rest of this entry on importing drug safety policy here.
Partnership for Safe Medicines Letter to President Barack Obama
April 8, 2009
President Barack Obama
1600 Pennsylvania Avenue, NW
Washington, DC 20500
Dear Mr. President,
On behalf of the Partnership for Safe Medicines (PSM) , a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines and dedicated to the safety of the drug supply, I would like to congratulate you on your efforts to improve health care and expand meaningful coverage for the millions of Americans who lack it. However, PSM is deeply concerned that the most vulnerable run the highest risk of encountering counterfeit, adulterated, or unsafe medicines and believe a comprehensive approach is needed to solve this patient safety problem.
We believe that safety must be our top national priority in any health reform effort. However, with respect to prescription drugs, today Americans unknowingly risk death or serious injury to their health by taking counterfeit drugs. Counterfeit drugs impact virtually every country in the world (including 115 in 2008) and virtually every disease state. Indeed, in 2008, there were at least 651 different types of counterfeit branded, generic and over-the-counter drugs discovered. Over the last several years, with improved appearance and packaging, these criminals have made their fake goods even harder to detect.1 This is clearly a growing global problem and requires many new types of international collaboration for effective investigation and interdiction.
Issue: Importation
In addition, this drug safety issue also has particular relevance to the debate on prescription drug importation into the U.S., one of several proposed cost-saving measures under consideration by Congress. I applaud your administration’s choice to study the issue before proceeding and would ask that any analysis focus upon several areas, including:
1. Lack of Regulation for Products Trans-Shipped Through "Safe" Countries such as Canada and U.K. Drug importation advocates believe that drugs purchased from countries such as Canada and the UK are safe because of their strict health regulations. Unfortunately, this is simply not true. For example, Health Canada clearly states drugs not earmarked for Canadians are not subject to the Canadian government’s safety regulations. Hence, drug exporters can bypass Canada’s safety regulations and mail fake or low-quality drugs made in high risk countries such as China and India to Americans without Health Canada’s oversight. Likewise, the UK indicates it lacks the power to stop suspected counterfeits on its shores destined for the U.S. because these goods are only transiting through the country. Indeed, recent conflicting E.U. rulings have resulted in U.K. customs now not stopping nor inspecting goods transiting through, allowing counterfeit medicines to move through the U.K. and into the U.S. undetected.
2. Inability for Importation to Satisfy US Demand and Foreign Provider and Citizen Resistance. There are simply not enough legitimate drugs in foreign supply chains to satisfy U.S. demand. For example, if just half of elderly Americans shifted their purchases to Canadian sources, it would exhaust the entire Canadian drug supply in a few months. Hence, both Canadian providers and citizens oppose U.S. importation. In addition, this reality could have considerable impact for our political and economic relationships with smaller countries like New Zealand, Czech Republic, Romania and others, whose supply could be devastated by parallel traders exporting most of their supply to the U.S.
3. Inaccurate Safety Perceptions for Foreign Risky Purchases. A drug importation policy will give Americans an inaccurate—indeed, dangerous—perception that buying drugs from any "Canadian pharmacy" is safe because "the government is allowing drug imports." This is particularly true for patients buying drugs through high-risk Internet drug sellers.
4. US Policy in Hands of Foreign Governments. Congressional importation proposals would place our drug policy in the hands of foreign governments. Price, quality, oversight (or lack thereof), and other critical issues will be defined by other governments without concern for U.S. patient protection and with unclear potential for safety regulation or enforcement. It would also reduce security of the supply chain to the weakest global link. The U.S. would effectively rely on the Asian, Baltic, and Balkan region countries to serve as our “border patrol” against counterfeit drugs. However, these countries do not have sufficient knowledge or capacity to do so and will prioritize the needs of their own citizens with the scarce regulatory resources they have.
5. Virtually No Cost Savings. The Congressional Budget Office estimates in its 2004 drug importation issue brief that reduction in drug prices from importation would be "small" or "only about 1% … [and] permitting importation only from Canada would produce a negligible reduction in [drug spending." Any savings would be virtually nonexistent because middlemen will reap all the profits and leave little, if any, savings for consumers. The reality is that prescription drugs from a safe, secure drug supply chain—regardless of whether or not it allows drug importation—will always be more expensive that those from an unsecured, potentially fraudulent supply chain.
Proposed Policy
Considering these risks, we urge you to educate Congress about the need to guarantee the safety of prescription drugs. This affects all of us, but our most vulnerable patient populations, such as minorities, seniors and fixed income patients would bear the brunt of any policy failure. Instead, we need to focus on creating substantive programs that maintain access to safe medicines by using the closely regulated and inspected U.S. supply chain. This could include:
1. Offshore FDA Support and Authority. The FDA needs funding and authority to develop programs and systems that tighten the drug supply chain. In order to stop counterfeit drugs and other unsafe products from pouring out of foreign manufacturing facilities and into the U.S., the FDA needs to establish more foreign field offices and staff them with both inspectors and criminal investigators armed with the same authority as their State-side colleagues. This includes the authority to enter and inspect foreign manufacturing facilities without previous notice.
2. Onshore FDA/Agency Support and Authority. The U.S. currently has 300 custom ports of entry, but the FDA only has 200 port inspectors and only 17 inspectors to cover all international mail centers. We must hire more inspectors here and grant the FDA and other agencies the authority to destroy unapproved and counterfeit drugs entering the US rather than returning them to the criminals who sent them here—our current policy.
Read the rest of this entry on prescription drug safety here .
U.S. Senate vote deferred on drug importation measure
A U.S. senator on Monday said he dropped plans to try to add a measure allowing importation of lower-priced medicines from other countries to tobacco legislation after being told the Senate will consider the drug issue separately.
Democratic Senator Byron Dorgan said that Majority Leader Harry Reid had promised to bring the drug importation measure to a Senate vote “very soon.” Dorgan said he expected the vote to happen within “a matter of a couple weeks.”
Last week, Dorgan said he planned to offer the importation measure as an amendment to a pending bill that would grant the Food and Drug Administration power to regulate cigarettes.
Read the rest of this article on drug safety here.
Education…The Prescription for Purchasing Medications
The cost of counterfeiting is much more than money. In too many cases, counterfeiting costs human health and in some cases lives. For example, a group of clinics in Sierra Leone were closed last week for allegedly administering counterfeit drugs. Other cases involving online drug sellers have claimed the health and lives of patients who bought from illicit Web sites.
Recently, the U.S. Department of Commerce and U.S. Chamber of Commerce released the Top 10 Ways to Protect Yourself From Counterfeiting and Piracy , contributing to the protection of consumers from the harms of counterfeit goods. Like many of the recommendations in our Consumer Resources , this list outlines ways consumers can take an active role in protecting themselves from all types of fake goods, including counterfeit drugs, by:
- Paying attention to questioning labels and packaging
- Identifying safe sellers, by visiting the U.S. Chamber’s Supply Chain Tool Kit , and for online pharmacies, looking for a seal of accreditation from the Verified Internet Pharmacy Practice Sites (VIPPS)
- Insisting on secure transactions
- Watching for absent sales tax charges
- Being cautious when purchasing products from abroad
Read the rest of this article on counterfeit drugs here.
Cheerios… A Threat Larger Than Counterfeit Drugs?
On May 5, the U.S. Food and Drug Administration (FDA) administered a warning against General Mills regarding the claim that Cheerios® Toasted Whole Grain Oat Cereal has the ability to lower cholesterol. Basically, the FDA cited General Mills for marketing Cheerios® as a cholesterol-reducing drug. I believe the FDA’s points are valid and factual, but I have to ask - Shouldn’t our agency watchdog be focusing greater attention on the operators of thousands of Web sites and the spammers who peddle contraband or counterfeit drugs to American consumers every day? What are the consequences for these dangerous marketing practices?
The Partnership for Safe Medicines (PSM) strongly suggests that the only way to curb the sale and distribution of counterfeit drugs is to introduce warnings and reprimands against dangerous online drug sellers and then to follow up and make sure they stop. Yes, it is important for consumers to understand that eating Cheerios® is not the solution to lowering cholesterol.
Read the rest of this article on counterfeit drugs here.
Malaria Disaster Looms From Bug’s Resistance, China Fakes
Saron Samnith, 14, slouches in the doorway of his family’s thatched hut off a dusty track near Pailin, a city in western Cambodia. He has chills, diarrhea and a three-day-old headache — signs of malaria.
The bout of the mosquito-borne disease, for which he tested positive, is his second in a month. The first left him comatose and in danger of dying, before medicines curbed the attack. Coursing through Saron’s veins may be the strain so dangerous that health officials –and the billionaire Bill Gates — are racing to stop it from spreading before it kills millions.
In Pailin, a flood of counterfeit pills from China and elsewhere is helping to breed a superbug that resists even the most-effective medicine. The development threatens to unleash a global malaria “disaster” and undo decades of work to reduce illness, destitution and death, said Arjen Dondorp, a Thailand- based researcher.
Read the rest of this article on counterfeit drugs here.
Trade in illegal medicine exposed
An undercover investigation by the BBC found illegal pharmaceutical drugs being sold by dealers in Kent.
The British Medical Association (BMA) said it was a crime that also robbed people of the chance to be diagnosed.
It is thought that more than two million people in the UK buy medicines over the internet, many of which are counterfeit, substandard or unapproved.
Read the rest of this article on counterfeit drugs here.
How Internet Search Engines Support Illegal Online Drug Sales
Did you know that Internet search engines, such as Google and Yahoo , claim to verify online pharmacies through PharmacyChecker.com? But what good does it do? This site provides little to no security about the legitimacy of Internet drug sellers. Rogue online pharmacies continue to profit from the sale of counterfeit drugs, and at the same time Internet search engines profit from the advertisements on these non-verified pharmacies’ Web sites. Even more alarming is that Internet search engines are in no way held accountable for hosting and profiting off “online pharmacies” who distribute counterfeit drugs.
While Congress has passed laws to combat selling prescription drugs online without a prescription, they have failed to include penalties for the search engines advertising these illegal operations. And organizations such as the World Health Organization (WHO), domestic agencies, and law enforcement agencies – who have attempted to increase penalties – are tied down by their lack of regulatory infrastructure and enforcement power.
Read the rest of this article on online pharmacies and counterfeit drugs here.