May 08, 2008
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.
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Posted in: Counterfeit Drugs
May 05, 2008
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.
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Posted in: Legislation
May 01, 2008
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.
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Posted in: Legislation
April 29, 2008
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.
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Posted in: Legislation
April 24, 2008
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.
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Posted in: Counterfeit Drugs Legislation
April 22, 2008
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.
>> Read More
Posted in: Counterfeit Drugs Legislation
April 17, 2008
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.
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Posted in: Counterfeit Drugs
April 16, 2008
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
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Posted in: Counterfeit Drugs
April 10, 2008
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?
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Posted in: Counterfeit Drugs
April 03, 2008
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.
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Posted in: Safe Medicines
March 27, 2008
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.
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Posted in: Counterfeit Drugs Legislation Safe Medicines
March 20, 2008
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.
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Posted in: Counterfeit Drugs Safe Medicines
March 13, 2008
Heparin Havoc Continues
It looks as though the problems from China-sourced heparin are far from over. An unknown substance, similar in chemical makeup to heparin, has been found in batches of the blood thinner produced by U.S.-based Baxter International and Germany-based Rotexmedica.
>> Read More
Posted in: Safe Medicines
March 11, 2008
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.
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Posted in: Counterfeit Drugs Counterfeit Drugs Importation
February 27, 2008
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.
Posted in: Counterfeit Drugs
December 19, 2007
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.
>> Read More
Posted in: Counterfeit Drugs
December 17, 2007
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.
>> Read More
Posted in: Counterfeit Drugs
December 12, 2007
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.
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Posted in: Counterfeit Drugs
December 06, 2007
An Easy Prescription to Follow
If you're looking to purchase drugs online, here are a couple of simple ways to increase the possibility the website you're considering buying drugs from is a legitimate website, and to protect yourself from receiving counterfeit or contraband drugs.
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Posted in: Safe Medicines
November 28, 2007
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.>> Read More
Posted in: Counterfeit Drugs Generic Drug Alternatives Importation Safe Medicines
November 26, 2007
November 20, 2007
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.
Posted in: Counterfeit Drugs
November 12, 2007
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.
Posted in: Importation
November 02, 2007
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.
Posted in: Legislation
October 31, 2007
A Scary Tale on Halloween
A front-page article in today's (10/31/07) New York Times exposed the scary reality about pharmaceutical ingredients exported from China: these ingredients "are often made by chemical companies that are neither certified nor inspected by Chinese drug regulators."
The frightful story doesn't end there.
The potentially harmful ingredients were being openly peddled by Chinese chemical companies at a major pharmaceutical convention this month in Milan, Italy. According to the New York Times' investigation, one third of the over 1,300 companies exhibiting at the convention were from China. Of these, several companies had been involved in recent government investigations and have a history of selling fake and, in some cases, lethal drugs. One scheduled company wasn't there -- it's owner is currently in a Houston jail after trying to sell drugs to customs agents (he was successful in getting his drugs into the European market).
The lack of regulation in China means that these chemical companies don't have to meet any drug-manufacturing standards and are easily able to export unapproved and counterfeit ingredients.
And now for the part that's really alarming:
"The substandard formulations made from those ingredients often end up in pharmacies in developing countries and for sale on the Internet, where more Americans are turning for cheap medicine," according to the Times. And unfortunately, the Times also reports that the FDA simply cannot inspect even a small fraction of the 700 or more Chinese manufacturers that may be sending drugs to the United States.
The Times' front page exposé is another chilling example of how more and more unsafe Chinese chemicals are finding their way into drug ingredients that make up the medicines bought by unsuspecting consumers. Unfortunately, consumers are buying these drugs from illegitimate sources, including many online sellers posing as Canadian pharmacies.
Kudos to the New York Times and its reporters for its great work revealing the extent to which counterfeit drugs are a serious patient safety problem that U.S. health experts believe "pose a greater threat to a broader segment of the American public," especially those buying their drugs on the Internet.
Click here to read the full investigative piece.
Click here to help protect yourself and your family by signing up for the SafeMeds email alerts of government counterfeit drug warnings.
Posted in: Safe Medicines
October 22, 2007
Welcome to the Safe Medicines Blog
I heard the other day that someone starts a new blog every minute of every day or some outrageous number like that. And here I am, adding to these stats with my own – Safe Meds.
Why?
This forum allows us to discuss the issue of buying safe prescription drugs, person to person. It’s about alerting people to the dangers of fake medicines and offering solutions to this very real problem.
>> Read More
Posted in: General