The Food and Drug Administration has sent warning letters to more than 50 U.S. doctors and medical clinics that may have purchased counterfeit cancer injectable medication. Originally the FDA sent 19 medical practices warnings in March. The FDA warns the physicians that purchasing from foreign or unlicensed medicine suppliers puts patients at risk of exposure to potentially fake, contaminated, ineffective and dangerous medication.
FDA official Dr. S. Leigh Verbois, Acting Deputy Director of the Division of Supply Chain Integrity asked physicians in 15 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. See map to find doctors warned in your state here.
“…your medical practice purchased multiple medications from a foreign distributor named Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc. (BDMI). Many of the products sold and distributed by this distributor have not been approved by the FDA,” said Dr. Verbois’ letters.
“The Agency has learned that one of the products distributed by Richards Pharma is a counterfeit version of Roche’s Altuzan 400mg/16ml. Even if the version had not been counterfeit, Altuzan itself is not approved by FDA,” the letters continue.
“Other drug products obtained from Richards Pharma, Richards Services, Warwick Healthcare Solutions, BDMI, or other foreign or unlicensed suppliers may be from unknown sources, may have unknown ingredients, may be counterfeit, or may not have been manufactured, transported or stored under proper conditions as required by U.S. law, regulations, and standards.
“Purchasing prescription drug products, such as injectable cancer medications, from foreign or unlicensed suppliers puts patients at risk of exposure to drugs that may be fake, contaminated, improperly stored and transported, ineffective, and dangerous. In virtually all cases, purchasing unapproved prescription drugs from foreign sources violates the Federal Food, Drug, and Cosmetic Act and is illegal.”
LEARN MORE ABOUT COUNTERFEIT CANCER MEDICATIONS
IN THE US AT THE 2012 PARTNERSHIP FOR SAFE MEDICINES INTERCHANGE.
The FDA letter goes on to point out that the medication counterfeited is not in short supply, and points back to an FDA Drug Integrity and Supply Chain Security memo released to physicians in January 2012. The letter states that the FDA knows that some physicians are purchasing unapproved injectable cancer medications, and reminds them that importing medications from foreign sources is in violation of the Federal Food, Drug and Cosmetic Act (FDCA).
Dr. Margaret Hamburg, Commissioner of the FDA, wrote in the FDA’s blog, “For patients with cancer, combating the disease is difficult enough. But to learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable.”
Asthmatics Can Save Money Safely by Buying from VIPPS Certified Online Pharmacies
Washington, D.C. (May 2, 2012) – Asthmatics suffer from both chronic shortness of breath that if treated inconsistently can lead to serious illness and the burden of daily medication which requires conscientious treatment as well as expense.
The United Kingdom’s Medicine & Healthcare Products Regulatory Agency (MHRA) confiscated £14.4 million in assets from a convicted counterfeit medicine dealer. Simon Martin Hickman, 52, from Manchester, was sentenced to two years imprisonment in June 2009 following a conviction of selling and supplying fake and unlicensed medicines, as well as money laundering £1.4 million, announced…
The United States Pharmacopeial Convention (USP) is hosting a two day workshop on good distribution practices and supply chain integrity in Rockville, MD. The objectives of the workshop are To discuss the breadth of current issues, regulations and solutions. Obtain additional input for USP General Chapter <1083>. Identify opportunities for USP's role in supply chain…
In honor of World Malaria Day, we are reprinting this blog post by PSM Board member Tom Kubic, President and CEO of the Pharmaceutical Security Institute originally posted on the Sproxil blog April 3, 2012.
This is a reprint of the FDA alert. XROCK INDUSTRIES, LLC Issues a Voluntary Nationwide Recall of X-ROCK, a Product Marketed as a Dietary Supplement to Support Male Sexual Performance, Due to Unlisted, Potentially Hazardous Ingredient XROCK INDUSTRIES, an independent distributor of the X-ROCK products, is conducting a user level voluntary recall of certain supplement products sold…
The National Association of Boards of Pharmacy has released year end data on safe online pharmacies showing the rise of the “affiliate network.”
While the number of legitimate online pharmacies safe for Americans remains at 4% of all, the growth of fake online pharmacies out of compliance with U.S. pharmacy laws and practice standards appears to be strongly linked to the spread of underlying source organizations called “affiliate networks” that proliferate the internet with copies of their websites.
The NABP has published a report, “Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: January 2012” which identifies 8,456 so-called online pharmacies that are out of compliance with U.S. pharmacy laws and practice standards. Of those, 8,265 appear to be network affiliated, 98%.
The NABP staff identified websites that use the same phone number, physical address, domain name registrant, website design or web business name as those being part of a rogue affiliate network. A rogue affiliate network is a group of internet drug outlets operated by one organization, which are frequently operated outside of the U.S.
“The common perception in America is that a discount retailer out there on the internet can, because of lower costs of business elsewhere, provide medication at below U.S. market rates. What they don’t know is that the medications are all coming from the same counterfeiters in India and China, and that a giant conglomerate of organized crime runs these hundreds of millions of websites that advertise as if they were ‘mom and pop’ small pharmacies on the internet,” said Carmen Catizone, NABP’s Executive Director.
Partnership for Safe Medicines Carl L. Alsberg, MD, Fellow, Timothy Mackey, UCSD PhD student and senior research associate, has been awarded one of four Interdisciplinary Scholar Awards at University of California San Diego’s university-wide competition.
Brazilian researchers for the Revista de Saude Publica have determined that counterfeit medicine seizures have tripled since 2007.