Recent Efforts by Chinese Government to Crackdown on Counterfeit Drugs Show Progress

March 3, 2013

Though China has long been linked to the manufacture of counterfeit drugs, the last two years have shown that Chinese authorities are taking counterfeit drug crime much more seriously. China’s Food and Drug Administration (SFDA) cracked over 14,000 cases last year, a major toxic gel capsule ring was broken up, and Chinese authorities are working in concert with both the FDA and major drug manufacturers to track down counterfeit drug manufacturers and prosecute them. The founding of Partnership for Safe Medicines China also demonstrates China’s stakeholders’ commitment to improving patient safety both at home and abroad.

China made great strides in the last year in their efforts to combat pharmaceutical counterfeiting. Their cooperation with the US Food and Drug Administration on inspections is helping to safeguard both US and Chinese consumers. The founding of Partnership for Safe Medicines China underscores a new commitment to ensuing drug safety within their borders. Partnership for Safe Medicines China is the latest branch of the leading advocacy organization dedicated to fighting the global threat posed by counterfeit and misbranded drugs.

National Boards of Pharmacy Releases 2013 Report, 97% of Online Pharmacies Not Recommended

March 3, 2013

The National Association of Boards of Pharmacy (NABP) has released their 5th annual report on Internet Drug Outlets. Published each year, it is a progress report for state and federal regulators that illustrates the state of online drug sales in the United States and the overwhelming dominance of fake online pharmacies in the global Internet marketplace.

As of March 4, 2011, NABP surveyed 10,275 internet pharmacies and found that 9,938 or 97% were classified as “Not Recommended”, meaning they did not comply with NABP patient safety and pharmacy practice standards, or state and federal laws.

UK’s Medicine Regulatory Agency Warns of Dangerous Ingredients in Herbal Remedies

February 26, 2013

On February 19th, 2013 the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) posted a press release warning of dangerous heavy metal contamination in unlicensed Chinese herbal medications produced in Hong Kong and sold internationally online. The herbal compounds are reported to contain mercury and lead, which can lead to health side-effects ranging from dizziness to kidney and brain damage, reports the MHRA.

The MHRA, which is the UK counterpart to the US Food and Drug Administration (FDA), states that the following products: “Bak Foong Pills – used to relieve menstrual discomfort, Fung Shing Paij Tian-Ma Wan – used to relieve arthritis and headaches, and Shi Hu Ye Guang Wan and Nai Chang Ming Yan Pills – both used to improve vision in adults” are all contaminated with either lead or mercury.

Avoid the Top 3 “Natural” Products That Threaten Your Heart

February 26, 2013

Before buying the next miracle cure for weight loss, joint pain, or intestinal distress, ask yourself, is it heart-smart to take a dietary supplement you know nothing about?

Heart disease is the number one cause of death in the US for both men and women.

In the last few years, some truly unexpected drug compounds that cause heart ailments have turned up in herbal dietary supplements despite claims to be “safe and all natural.” To honor American Heart Month, take the pledge to guard your heart by being a smart shopper and only taking dietary supplements when you know the ingredients are safe.

Learn more about the top three herbal supplement ingredients that are neither natural nor herbal.

Institute of Medicine Releases Report on Falsified and Substandard Drugs

February 19, 2013

On February 13, 2013, the Institute of Medicine (IOM) released
their report, “Countering the Problem of Falsified and Substandard Drugs” that
reviews the current state of substandard and falsified drugs globally, and offers
a series of recommendations to combat drug falsification and to encourage
global cooperation on drug safety.

Food and Drug Administration Commissioner Dr. Margaret
Hamburg commends the FDA commissioned report because it “spotlights a critical global public health
issue. Falsified and substandard medicines adversely affect the lives of
millions around the world, and the issue must be elevated to the highest levels
of international discourse.”

Partnership for Safe Medicines India Rolls Out Drug Verification Project for Patients

February 19, 2013

On February 15, 2013 at the India Habitat Centre in New Delhi, the Partnership for Safe Medicines India proposed an initiative “to study the extent of spurious and not-of-standard medicines in India and adopt policies to ensure safety and quality in the supply chain.”

An unprecedented pilot program supported by the PSM India will provide low-cost medicine evaluation for patients at accredited government approved laboratories. The goal of the pilot program is to “establish trust on the quality and existing regulatory standards between the manufacturers and the consumers,” said P. D. Sheth, VP, International Pharmaceutical Federation.

New Counterfeit Avastin Found – Medical Practitioners Advised by FDA to Be Wary of Unfamiliar Wholesalers

February 12, 2013

Breaking News: US Food and Drug Administration (FDA) has identified a third batch of counterfeit cancer medication in the United States. On February 5, 2013, the FDA posted a health practitioner warning about this latest counterfeit version of the cancer treatment Avastin.

According to the FDA “lab tests have confirmed that at least one batch of a counterfeit version of Roche’s Altuzan distributed in the United States contains no active ingredient.” The counterfeit drugs allegedly have been distributed by New York-based supplier, Medical Device King/Pharmalogical, reports the FDA warning. This is the first time a US drug supplier has been implicated in the distribution of counterfeit cancer drugs.

Influenza Outbreaks Inspire Drug Counterfeiters to Exploit Anxious Populace

February 12, 2013

7,224 hospitalizations for laboratory-confirmed flu cases have occurred in the United States since October 1, 2012, according to the US Centers for Disease Control (CDC) Weekly Flu Update. Additionally, a January 25th CDC news release reports that influenza infection rates have been running at least 2 percentage points above epidemic classification for the past three weeks. While the CDC and other public health entities are encouraging consumers to be vaccinated, drug counterfeiters look at the US flu epidemic as a cash-making opportunity, warns the US Food and Drug Administration (FDA).

The FDA’s February 1 consumer update warns “As the flu continues to make people sick—and even cause deaths—scammers are alive and well, promoting their fraudulent products to the unsuspecting public.”

Health Care Provider Alert: Another Counterfeit Cancer Medicine Found in United States

February 8, 2013

This is a reprint of an FDA Alert. Purchasing Unapproved Drugs is Risky Business [2/5/2013] The Food and Drug Administration is committed to protecting the supply chain against counterfeit and unapproved medicines that enter the United States through fraudulent sources. As part of this vigilance, FDA is alerting health care professionals that an unapproved cancer…

Update On Fake Avastin – FDA Warnings in 28 States, Six Prosecutions

February 5, 2013

On February 12, 2012, the FDA sent out a public warning that counterfeit versions of the injectable cancer medication Avastin, had been found in the US drug supply chain. Since that time, a second warning was issued on counterfeits of the Turkish version of Avastin, Altuzan had also been found in the US, five US citizens, including three doctors have been prosecuted for selling or purchasing misbranded cancer medication, and an additional 134 doctors in 28 states have been sent FDA warning letters concerning their dealings with the foreign supplier that was the source of the counterfeit Avastin.

In the last 12 months, the US Food and Drug Administration (FDA) has issued warning letters to 134 US doctors informing them that they may have purchased counterfeit cancer medication. They were warned about purchases of unapproved medications, including unapproved versions of the injectable cancer treatment, Avastin, from wholesale drug distributors operated by foreign suppliers outside US jurisdiction. Each letter sent explained that the foreign drug wholesaler the doctors did business with were the source of the counterfeit Avastin that had infiltrated US drug supplies.

The first warning letters were sent out February 10, 2012 to 19 doctors. In April, two sets of letters, one dated the 5 and the second dated the 23rd, were sent to an additional 59 doctors. On June 28th, 55 more doctors received warnings, bringing to current total to 134 doctors in 28 states. California leads the pack where 57 California doctors were warned by the FDA about counterfeit cancer drug purchases.

The current warnings about counterfeit versions of Avastin or Altuzan were issued on June 28th, 2012. The FDA letter states “The U.S. Food and Drug Administration has received information indicating that your medical practice purchased multiple medications from a foreign distributor named Clinical Care, Quality Specialty Products (QSP), Montana Healthcare Solutions, or Bridgewater Medical. Most, if not all, of the products sold and distributed by this distributor have not been approved by the FDA and may include counterfeit versions of Avastin or Altuzan.”

These most recent warnings were sent to doctors in Alaska, California, Colorado, Florida, Georgia, Illinois, Kentucky, Michigan, Mississippi, Missouri, Nevada, New Jersey, New Mexico, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Vermont, Virginia, and West Virginia.