Sunday, December 21, 2014
May 2013 Update Minimize

Operator Of Canada Drugs Subsidiary Pleads Guilty In Counterfeit Drugs Case

On March 21, 2013, Paul Bottomley, a UK citizen and founder of Montana Healthcare Solutions, signed a plea agreement wherein he accepted his guilt for his role in the distribution of counterfeit cancer medication, reports the Wall Street Journal. According to the  Plea Agreement, Bottomley waved the right to a jury trial and agreed to plead guilty to misprision of a felony, or aiding in the commission of a felony. The plea agreement also states that Bottomley “maintains he can provide substantial assistance to the United States” and in so doing, further reduce his sentence.  

Bottomley had previously agreed to forfeit the proceeds of his business to the Federal Government, including land and an ostentasiously expensive Aston Martin, sold at auction for $110,000, reports the Missoulan.

Bottomley initially denied any connection to the fake Avastin distribution, telling CBS news via text that Montana Healthcare Solutions had shut down in 2010, and that he “knew nothing of this Avastin matter.” Subsequent investigations however linked him to the sale of the fake Avastin. CBS reports further that a doctor they spoke to received a price sheet in 2011 from MHS with Bottomley listed as the “Business Development Director.”

Back in February 2012 when the FDA first reported that counterfeit Avastin had been found at US doctors’ offices, they identifiedMontana Healthcare Solutions as one of the suppliers. At that time MHS’s links to online pharmacy giant Canada Drugs were not as yet understood. In July of 2012, the Wall Street Journal linked the two companies in print for the first time. Montana Healthcare Solutions has since been identified by the FDA as “owned and operated by Canada Drugs.”

In related news, The Winnepeg Sun is reporting that Canada Drugs has laid off hundreds of employees in the wake of the FDA’s efforts to shut down their US operations.

To learn more about the safety of purported Canadian Internet pharmacies, and to insure that your medicine stays safe read “The 5 Secrets Canadian Web Pharmacies Don't Want You To Know.” 

To learn more about the counterfeit Avastin case, and check to see if your doctor received a warning letter from the FDA about fake cancer medication, read our Update on Fake Avastin.

  

February 2013 Update Minimize

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

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 medicine distributed by a U.S. company, Medical Device King (also known as Pharmalogical), is counterfeit.

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.

Even if the identified product were not counterfeit, Altuzan (bevacizumab), an injectable cancer medicine, is not approved by FDA for sale in the United States. The only FDA-approved version of bevacizumab for sale in the United States is called Avastin, marketed by Genentech.

Medical practices that have obtained any medical products from Medical Device King, Pharmalogical, and Taranis Medical (another company associated with Pharmalogical) should stop using the products due to concern that the products may be unsafe or not effective. Health care professionals should contact FDA’sOffice of Criminal Investigations (OCI) to arrange for the collection of these products.

Medical practices that purchase and administer unapproved medicines are putting patients at risk of exposure to medicines that may be counterfeit, contaminated, or improperly stored and transported. For most of these medicines, there are FDA-approved versions readily available in the United States. FDA cannot ensure the safety and efficacy of any product that has not undergone the rigorous scientific review that is part of FDA’s approval process. To protect patient health, health care professionals should use only FDA-approved medicines.

The product labeled as Altuzan (bevacizumab) 400 mg/16 mL may be counterfeit if it displays the following batch numbers and expiration dates:    

Batch No.

Exp. date

B6022B01

11  2013

B6024B01

02  2013

(These batch numbers are in addition to those previously identified by FDA as suspect counterfeit products.1)

How Health Care Professionals Can Help Ensure Safety of their Patients

To minimize the chance of patients being exposed to medicines that may be counterfeit, contaminated, or improperly stored and transported, health care professionals should be cautious when ordering products from new or unknown suppliers.

1. Be wary if the price of a medicine sounds too good to be true. Deep discounts may be offered because the product is stolen, counterfeit, substandard, or unapproved.

2. Carefully inspect the product and packaging. Look for these signs, which may indicate that the product is not FDA-approved:

  • The medicine has a different name than what was ordered.

  • The packaging or label looks different from the product you usually receive.

  • Portions, or all, of the labeling are not in English.

  • The dosing recommendations are unfamiliar.

  • The dosage form or route of administration is different (e.g., ampule instead of pre-filled syringe).

  • The product does not display a National Drug Code (NDC) number.

3. Determine if the medicine you have received is FDA-approved by checking the Orange Book or Drugs@FDA.

4. If you receive multiple complaints about the same product, such as a new side effect or lack of therapeutic effect, these may signal a product quality issue. Report product quality issues and adverse events to FDA using the MedWatch system.

Health care professionals and patients should report adverse events related to the use of suspect medicines to FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax, or by phone. Health care professionals and consumers can either:

  • Complete and submit the report online: www.fda.gov/MedWatch/report.htm, or

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. 

FDA is asking the public to report suspect products obtained from Medical Device King, Pharmalogical, Taranis Medical, or other questionable sources:

FDA is committed to promoting and protecting the public health by ensuring that safe, effective, and high-quality products are available to the American public.
 

Footnote:

1 Links to previous FDA alerts:

  

May 13, 2012 Update Minimize

The FDA has Warned More Doctors About Buying Potentially Fake Medicines From Unauthorized FDA Sources.  
Is Your Doctor On The List Of Doctors Put on Notice?

Click on the red pins below to see which doctors have been warned by the US FDA

 

 

The US FDA has sent letter to more than 50 doctors and clinics that may have purchased counterfeit medications.  The FDA has warned these physicians that purchasing from foreign or unlicensed suppliers puts patients at risk to fake, contaminated, ineffective and dangerous medicines.

FDA official Dr. S. Leigh Verbois, Acting Deputy Director of the Division of Supply Chain Integrity asked physicians in 13 states to avoid using the fake medications in letters dated April 5, 2012.   

The doctors who received these letters reside in Alabama, Arizona, California, Florida, Illinois, Maryland, Michigan, Nevada, New Jersey, North Dakota, Oregon, South Carolina, Tennessee, Texas and Washington. 

The FDA requests that these physicians and clinics cease using, and retain and secure all remaining products purchased from Richards Pharma, Richards Services, Warwick Healthcare Solutions, BDMI, or any other foreign or unlicensed U.S. sources until further notice. The FDA instructs these physicians and clinics not return any product(s) to the place of purchase at this time. The FDA is continuing to evaluate this situation, and we will provide further instructions regarding the disposition of the product(s) at a future date.

 

 

 

  

Fake Cancer Drug Found in US Traveled the World First Minimize


20-April-2012 Update:  The FDA has warned clinicians in 12 states about purchasing medications from foreign or unlicensed suppliers selling illegal prescription medications. "These medical practices are putting patients at risk of exposure to medications that may be counterfeit, contaminated, improperly stored and transported, ineffective and dangerous," the FDA said in a statement. The FDA has encouraged medical practices to purchase drugs directly from manufacturers or licensed U.S. wholesale distributors.

FDA received information that the U.S. medical practices listed below purchased medications from foreign or unlicensed suppliers that sold illegal prescription medications. These medical practices are putting patients at risk of exposure to medications that may be counterfeit, contaminated, improperly stored and transported, ineffective, and dangerous. To minimize the chance of patients receiving a counterfeit, unsafe, or ineffective medication, FDA is requesting that the medical practices stop administering drugs purchased from any foreign or unlicensed source.

FDA urges the healthcare community to examine their purchasing practices to ensure that they buy directly from the manufacturer or from licensed wholesale drug distributors in the United States. FDA reminds healthcare professionals, pharmacies, and wholesalers/distributors that they are valuable partners in protecting consumers from the threat of unsafe or ineffective products that may be stolen, counterfeit, contaminated, or improperly stored and transported.  The receipt of suspicious or unsolicited offers from unknown suppliers should be questioned, and extra caution should be taken when considering such offers.
 
To view the list of physicians that the FDA has warned by state,
click here

 

 

10-April-2012 Update:  US FDA Commissioner, Dr. Margaret Hamburg blogs about improving the integrity of the drug supply in a global marketplace.  The FDA is already working to increase transparency and accountability in the supply chain, developing better enforcement and regulatory tools, encouraging greater responsibility by manufacturers and other stakeholder, and enhancing collaboration with international regulatory counterparts.  Dr Hamburg also called for authority to require a robust system to track and trace all drugs throughout the supply chain. She said "It would provide greater transparency and accountability in our nation’s drug supply, help to prevent the introduction and improve identification of counterfeit and other substandard drugs, and facilitate recall efforts."  To read entire blog, click here.

 

04-April-2012 Update:

The U.S. Food and Drug Administration has found a new batch of counterfeit Avastin in the U.S. and apparently distributed by a different network from the one connected to an earlier fake supply of the cancer drug.  In this case the fakes were packaged in boxes labeled as Altuzan, the brand name for Avastin in Turkey. FDA tests confirmed that the fakes lacked any Avastin.

"Packaging or vials found in the US that claim to be Roche's Altuzan are identified with lot number B6021 and should be considered counterfeit," FDA said.
 

 


The FDA said medical practices in the U.S. bought this batch from a supplier overseas called Richards Pharma, which is also known as Richards Services, Warwick Healthcare Solutions or Ban Dune Marketing Inc.

A company called Richard's Pharma Ltd. lists an address in Warwick, England, and is in the business of distributing pharmaceuticals, according to U.K. company filings. Ban Dune Marketing Inc. was based in La Jolla, Calif., before closing last August, according to state corporation records

In February, the FDA first warned that a counterfeit supply of Avastin had turned up in the U.S. The counterfeits were traced that supply through a network of firms in Canada, Barbados, the U.K., Denmark, Switzerland and Egypt.  Learn more about the February incidents by watching two brief news reports from CBS News below:

 

The next video clip is an interview of the owner of the companies that imported the counterfeit Avastin to the US


 

To view or download a slide deck that summarizes how the fake Avastin entered into the US,  click here

 

To report suspect counterfeit products and other suspect unapproved products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions or other sources:

 

  

 

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