Counterfeit Version of Avastin in U.S. Distribution

Statement Issued: Feb. 14, 2012

FDA sends letters to 19 medical practices about counterfeit product and other unapproved cancer medicines  

The U.S. Food and Drug Administration (FDA) is warning health care professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States.  Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors’ offices. The counterfeit version of Avastin does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy. 

In a related action, FDA has issued letters to 19 medical practices in the United States that purchased unapproved cancer medicines that may include the counterfeit Avastin.  The counterfeit version is labeled as Avastin, manufactured by Roche. Roche is the company that  manufactures Avastin approved for marketing outside of the United States. 

Roche conducted laboratory tests that confirmed the counterfeit version of Avastin.  Packages or vials may be counterfeit if they:

• are labeled with Roche as the manufacturer
• display batch numbers that start with B6010, B6011 or B86017 

The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials.  In addition, Genentech’s FDA-approved version of Avastin vials and packaging have a 6-digit numeric batch number and expiration dates in a 3-letter month and 4-digit year format (e.g., JAN 2014).  Genentech’s Avastin products are safe and effective for their intended uses.

The 19 medical practices in the United States purchased unapproved cancer medicines and, potentially, the counterfeit Avastin, from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions.  Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products.  FDA has requested that the medical practices stop using any remaining products from these suppliers.  FDA cannot ensure the safety or efficacy of any of these unapproved products.

• Letters to Doctors About Purchasing Unapproved Injectable Cancer Medications  

Based on information to date, FDA has determined that none of the unapproved cancer medicines received by these medical practices from Volunteer Distribution are in shortage in the United States.  FDA-approved versions of these medicines are available in adequate supply to meet current demand. 

Medical practices that have obtained unapproved products from foreign sources, in particular from Volunteer Distribution and/or QSP, should stop using them and contact the FDA.  These products should be retained and securely stored.

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

• Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or  
• Visit OCI’s Web site (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm), or
• Email - DrugSupplyChainIntegrity@fda.hhs.gov 

Health care professionals and consumers are asked to report adverse events related to the use of suspect injectable cancer medicines to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax, or by phone. Health care profssionals 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 continues to evaluate this counterfeit medicine situation and we will provide updates.

For information about this counterfeit medicine, see Roche’s statement: http://www.gene.com/gene/news/press-releases/press_statements/ps_021412.html

 

For more information about counterfeit medicine: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htm. 

 

Pictures of the counterfeit version of Avastin are shown below:

Prosecution for Introduction of Misbranded Prescription Drugs Imported From China

U.S. Department of Justice Press Release

For Immediate Release June 14, 2012 www.usdoj.gov/usao/txs	United States Attorney Southern District of Texas Contact: Angela Dodge Public Affairs Officer (713) 567-9388

HOUSTON – A Houston federal jury has convicted Luis Angel Garcia Torres, 41, of Patillas, Puerto Rico, has been convicted of 12 counts in relation to the trafficking of counterfeit goods, United States Attorney Kenneth Magidson announced today. Torres was found guilty just a short time ago by a jury sitting in Houston following four days of trial and five hours of deliberation. The jury convicted Torres of one felony count of conspiring to traffic in counterfeit goods, causing the introduction of misbranded prescription drugs into interstate commerce and causing the introduction of counterfeit prescription drugs into interstate commerce. He was also convicted of six felony counts of trafficking in counterfeit goods as well as three misdemeanor counts of causing the introduction into interstate commerce of drugs that are misbranded and two misdemeanor counts of trademark counterfeiting. Torres used the Internet to obtain and distribute counterfeit Viagra and Cialis pharmaceutical drugs, which are Food and Drug Administration (FDA)-approved prescription drugs used in the treatment of erectile dysfunction. Viagra is manufactured and distributed exclusively by Pfizer Pharmaceuticals, while Cialis is manufactured and distributed exclusively by Eli Lilly. Both are registered trademarks on the principal register in the United States Patent and Trademark Office. During trial, evidence established that Torres offered Viagra and Cialis tablets for sale. The retail cost at the time for Viagra and Cialis ranged from $15.00 to approximately $20.00, but evidence established he was offering them for sale for just $2.00 each. Evidence also established he was purchasing the tablets for $.45 each. Testimony further established that Homeland Security Investigations (HSI) agents, working in an undercover capacity, purchased approximately 3600 Viagra and Cialis tablets from Torres via the Internet from Jan. 25, 2010, through Aug. 16, 2010. Evidence indicated the pharmaceuticals were exported from China and shipped from a Puerto Rico address used by Torres to undercover agents in Houston. The pharmaceuticals were later analyzed by the trademark holders and the FDA Forensic Chemistry Center and determined to be counterfeit. Agents also obtained a search warrant for the email address used by Torres and found proof he had obtained counterfeit pharmaceuticals from China and discussed techniques to evade detection and seizure by law enforcement officials with individuals residing in China. Torres faces a maximum sentence of 10 years in federal prison, without parole, and a $2 million fine at his sentencing hearing, set for Aug. 30, 2012. United States District Judge Keith Ellison, who presided over the trial, has permitted Torres to remain free on bond pending that hearing. The charges brought against Torres were the result of a joint investigation which began in November 2009 by HSI and the FDA-Office of Criminal Investigations. This case is being prosecuted by Assistant United States Attorney Andrew Leuchtmann and Assistant United States Attorney Samuel Louis. For additional information click here.

Use of Compound Drugs in Research With Animals

The Office of Laboratory Animal Welfare of the United States Deparment of Health and Human Services presented a Seminar on March 1, 2012, on the Use of Non-Pharmaceutical-Grade Chemicals and Other Substances in Research with Animals.  To view the Powerpoint Presentation from this seminar, click here.

Guidance Regarding Importation of API into the United States

A 2008 FDA seminar provided the following information regarding importation of API into the United States:
Pharmacy Compounding
a. Labeling (Must):
• “For Prescription Compounding”
• “Rx only”
b. Useful Information:
• API is a component of an FDA approved drug
• API meets official compendial requirements when applicable
Example: Certificate of Analysis
• Drug has not been withdrawn or removed from the U.S. market for public
health reasons (list in CPG 460.200)
• API product name and NDC #
• Name of API manufacturer and registration number
• A written commitment that the API will be sold and used solely for
pharmacy compounding by a state licensed pharmacy or federal facility
• A written commitment that the drug has not been withdrawn or removed
from the U.S. market for public health reasons

The remainder of the seminar outline can be found here.

HIPPA and Compounding Pharmacies

HIPPA requirements apply also to compounding pharmacies.  To read an article regarding how HIPAA is being enforced, click the following:  With Regulatory Enforcement of HIPAA on the Rise and Increased Penalties for Non-Compliance, Pharmacies Must Take Action.

Texas Pharmacy Association Conference

The Texas Pharmacy Association has scheduled its conference for July 26-28, 2012, at the Woodlands Waterway Marriott Hotel in The Woodlands, TX.   To view the schedule, click here.  To register click here.

The Society of Veterinary Hospital Pharmacists Position on Compounding Drugs for Use in Animals

Below is the position of the Society of Veterinary Hospital Pharmacists with regarding to compounding drugs for use in animals.

The Society of Veterinary Hospital Pharmacists
Position Statement on Compounding of Drugs for Use in Animals
Purpose: The Society of Veterinary Hospital Pharmacists (SVHP) is an international professional organization of veterinary hospital pharmacists. Recognizing that compounding is essential to providing high quality pharmaceutical care for some animal
patients, SVHP, in keeping with our educational mission, seeks to identify concerns and offer guidance in compounding for veterinary patients. Therefore, SVHP endorses the following position statement on compounding for animals.
SVHP POSITION STATEMENT ON COMPOUNDING OF DRUGS FOR USE IN ANIMALS
1. Prescriptions for all compounded preparations shall be initiated by a veterinarian based on an individual patient’s need within the context of a valid veterinarian-client-patient relationship. Compounded medication may be dispensed to veterinarians for office use where applicable state/provincial law permits. Items compounded for office use may only be administered in the veterinarian’s office and not dispensed for use outside of the veterinarian’s office.
2. Compounding for veterinary patients shall comply with regulations promulgated by state/provincial boards of pharmacy, federal regulations, and legislative statutes.
3. SVHP supports food chain safety and discourages compounding for food animals. Food safety concerns preclude the use of compounded preparations unless information exists to assure avoidance of illegal residues in food. The extralabel use of specific drugs is banned in food-producing animals. Food animals are defined by “intended use” rather than species.

FDA Townhall at BIO 2012--Upcoming Priorities Include Compounding

FDA Townhall at BIO 2012

China Cracks Down on Sale of Compounds Containing Ephedrine

China cracks down on illegal sales of drugs

Updated: 2012-05-31 13:24

BEIJING - China's drug watchdog has urged local authorities to mete out severe punishments on illegal sales of compound drugs containing ephedrine, calling for stricter control over these drugs that can easily be turned into meth.
In a circular published on its website earlier this week, the State Food and Drug Administration (SFDA) urged local drug authorities to seriously implement relevant laws and regulations on controlled drugs and strictly control the production and marketing of ephedrine-containing drugs.
Drug regulatory authorities will revoke the production or marketing licenses of pharmacies and enterprises that sell compound drugs containing ephedrine for making meth through illegal channels, regardless of the quantity, the circular said.
The circular came after a number of cases in which a great deal of compound drugs containing ephedrine, such as the cold remedy New Contac, were sold in some pharmacies around the country, giving rise to meth-making opportunities.
In Lishui county of East China's Jiangsu province, a pharmacy sold 400 boxes of New Contac to an unidentified person in June 2011, violating a regulation limiting the sale of ephedrine-containing drugs to 50 pills, or five 10-pill boxes. The drugs were used to make meth, and the pharmacy's marketing license has been revoked, the circular said.
The SFDA also called for strictly controlling ephedrine-containing compound drugs, widely publicizing and educating the public on the risks of ephedrine and raising enterprises' awareness.

Medicaid claims for Compound Drugs

The Office of  Inspector General of the United States Department of Health and Human Services issued the following statement regarding Medicaid claims for compound drugs:

Compound Drug Claims
We will review a State agency’s Medicaid claims for compound drugs to determine whether the drugs’ components complied with Federal requirements for reimbursement and collection of rebates. We will identify claimed drug components that are not eligible for Medicaid coverage and determine whether accountability and controls were established for collecting eligible drug component rebates. Compound drugs are custom blended by pharmacists from bulk ingredients based on doctors’ prescriptions. For payments to be available under Medicaid or Part B of Medicare, Federal law requires manufacturers to enter into and have in effect rebate agreements with the Secretary of Health & Human Services (HHS) (except that the Secretary may authorize a State to enter directly into agreements with a manufacturer) and meet certain other requirements. (Social Security Act, § 1927.) States may then claim Federal financial participation (FFP) and report drug utilization to the manufacturers for rebates. CMS requires States to use a drug tape that lists all drugs covered by rebate agreements to determine whether the drugs they purchase are eligible for Medicaid coverage. (CMS’s Medicaid Drug Rebate Program State Release No. 130.) CMS outlined States’ responsibility for preventing claims for terminated drugs in its Medicaid Drug Rebate Program State Release No. 19. (OAS; W-00-12-31317; various reviews; expected issue FY 2012; work in progress.

Report is found here.