Archive for 2013
Institute of Medicine Releases Report on Falsified and Substandard Drugs
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
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.
[...]Shri Keshav Desiraju
Shri Keshav Desiraju, Secretary, Health and Family Welfare, Govt. of India delivering Inaugural Address at the Open House Consultation on Accessibility to Safe and Quality Medicines in the Supply Chain in India in New Delhi February 15, 2013.
[...]Brother of Lebanese State Minister Arrested in Counterfeit Drugs Case
View in larger map Abdul Latif Fneish, the brother of Lebanese Minister of State for Administrative Affairs, Mohammad Fneish, has had an arrest warrant issued against him in Lebanon as a result of his links to counterfeit drug importation. In November 2012, Abdul Latif was linked via media reports to the forging of laboratory test…
[...]New Counterfeit Avastin Found – Medical Practitioners Advised by FDA to Be Wary of Unfamiliar Wholesalers
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
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
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…
[...]7 Sentenced in China For Producing Toxic Gel Medicine Capsules
View in larger map 7 people in China have been sentenced up to 11 years in jail for producing chromium-laced gel medicine capsules. The case first came to light in April 2012 , when Chinese authorities arrested 72 people for producing drug capsules produced from industrial grade gelatin rendered from leather processing. Who: Chinese State…
[...]3rd Instance of Counterfeit Cancer Treatment Found in United States
View larger map A third instance of a counterfeit version of the cancer therapy drug Avastin, labeled Altuzan (as it is labeled in Turkey) has been found in the United States, announced the FDA. The FDA has conducted tests on samples of the drug and found them to be counterfeit. Medical practices obtained the counterfeit…
[...]Update On Fake Avastin – FDA Warnings in 28 States, Six Prosecutions
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.
[...]