FDA Drug Safety Information

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Originally, 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.

Consequently 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.

In addition to the series of FDA warning letters that have been sent to doctors, the FDA has posted two separate public warnings about counterfeit versions of the injectable cancer medication, Avastin (Bevacizumab). The first warning, sent out in February 2012, identified counterfeit versions of Avastin with foreign-language labeling and misidentification as having been produced by Roche. The second warning was sent out concerning a so-called Turkish-made version of Avastin, Altuzan (as it is labeled in Turkey).

There have also been to date, four prosecutions associated with the counterfeit Avastin case. James Newcomb of La Jolla, California pleaded guilty in 2012 on charges of conspiracy to cause the introduction of adulterated prescription drugs into interstate commerce. Newcomb’s medical supply company, Ban Dune Marketing Inc (BDMI) of La Jolla, CA. has been cited as one of the sources of the counterfeit injectable cancer drugs discovered in the US supply chain in February and April of 2012, reports the FDA.

On August 11, 2011, Maryland oncologist Dr. Isabella Martire was reported by the FDA to have pled guilty on charges of introducing a misbranded drug into interstate commerce. Martire purchased non-FDA approved cancer drugs from a supplier based in the United Kingdom and used them to treat her patients. She also sought reimbursement from health insurers such as Medicare, Medicaid, and both private and federal health insurers. In May 2011, federal agents conducted a warranted search at Dr. Martire’s offices, where they found several boxes of misbranded drugs purchased from outside the United States. The packaging inserts and box labels were almost entirely in Turkish, according to the US Department of Justice.

Saint Louis, MO oncologist, Dr. Abid S. Nisar was reported by the FDA to have pled guilty on charges of distributing and receiving misbranded and adulterated prescription drugs, including the cancer treatment drugs marketed in the United States as Neupogen, Herceptin and Rituxan. Nisar purchased counterfeit cancer drugs from Ban Dune Marketing Inc, the company owned by James R. Newcomb. Nisar is reported to have taken 47 different shipments from February through December 2010, according to the FDA press
release on the occasion of his guilty plea.

Dr. William Kincaid, of Johnson City, TN, was reported convicted by the Department of Justice on November 15th, 2012 for repeatedly purchasing non-FDA approved cancer medications from Quality Specialty Products (QSP). Dr. Kincaid was charged with a felony count of introducing misbranded drugs into interstate commerce with the intent to defraud patients and the state’s Medicaid program. He pleaded guilty and admitted that his clinic purchased unapproved, discounted cancer medications, according to his plea

Michael Dean Combs worked as Dr. Kincaid’s office manager. The Department of Justice reported on September 19th, 2012 that he pled guilty and confessed to purchasing $2 million in misbranded cancer drugs approved for use in the US.

In the June 28th, 2012 set of warning letters sent to doctors, S. Leigh Verbois, Ph.D. Acting Deputy Director of the Division of Supply Chain Integrity continues, “Drug products obtained from Clinical Care, QSP, Montana Healthcare Solutions, Bridgewater Medical, 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. Such products put patients at risk of exposure to ineffective or dangerous drugs.”

Deputy Director Verbois also points out that “FDA has previously posted information about U.S. medical practices which are putting patients’ health at risk by purchasing medications from foreign or unlicensed suppliers that sold illegal prescription medications that may have included counterfeit versions of Avastin and Altuzan.”

The suppliers cited in the 6/28 warning letters have subsequently been identified in FDA letters, as being “owned and operated” by Canada Drugs. Those letters warned hundreds of doctors throughout the United States that they may have purchased misbranded or counterfeit Botox from some of the same Canada Drugs affiliates as mentioned above, reports the FDA.

By S. Imber