FDA's Unapproved Drugs Initiative

In June 2006, the FDA announced a new drug safety initiative to remove unapproved drugs from the market, including a final guidance entitled "Marketed Unapproved Drugs—Compliance Policy Guide (CPG)," outlining its enforcement policies aimed at efficiently and rationally bringing all such drugs into the approval process. The FDA uses a risk-based enforcement program in order to concentrate its resources on those products that pose the highest threat to public health and without imposing undue burdens on consumers, or unnecessarily disrupting the market. For all unapproved drugs, the CPG gives highest enforcement priority to the following:

• Drugs with potential safety risks
• Drugs that lack evidence of effectiveness
• Health fraud drugs
• Drugs that present direct challenges to the new drug approval and OTC drug monograph systems
• Unapproved new drugs that are also violative of the Act in other ways
• Drugs that are reformulated to evade an FDA enforcement action

Summary of Compliance Policy Guide

The Marketed Unapproved Drugs—Compliance Policy Guide (CPG):

• provides official notice that any illegally marketed product is subject to FDA enforcement at any time
• clarifies that the FDA intends to use a risk-based approach to enforcement
  • once the risk-based assessment has been made, the FDA can and will take any number of enforcement actions, including but not limited to:
    • requesting voluntary compliance
    • providing notice of action in a Federal register notice
    • issuing an untitled letter
    • issuing a warning letter, or
    • initiating a seizure, injunction, or other proceeding

What are unapproved drugs and why are they on the market?

From FDA website:

What are unapproved drugs and why are they on the market?

The original Federal Food and Drugs Act of 1906 brought drug regulation under federal law. That Act prohibited the sale of adulterated or misbranded drugs, but did not require that drugs be approved by FDA. In 1938, Congress required that new drugs be approved for safety.  In 1962, Congress amended the 1938 law to require manufacturers to show that their drug products were effective, as well as safe. As a result, all drugs approved between 1938 and 1962 had to be reviewed again for effectiveness.  To be consistent with current regulations and to ensure that all drugs have been shown to be safe and effective, all new drugs are required to have an approved application for continued marketing.

Many healthcare providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval.   In addition, since many unapproved drugs are marketed without brand names and have been available for many years, it is often assumed that these unapproved drugs are generic drugs.  This is not correct. Generic drugs have been evaluated and approved by FDA to demonstrate bioequivalence to a brand name reference drug.  Healthcare professionals and consumers can be assured that FDA-approved generic drug products have met the same quality, strength, purity and stability as brand name drugs. Additionally, the generic manufacturing, packaging, and testing sites must meet the same quality standards as those of brand name drugs. Unapproved drug products have not been evaluated and approved by FDA. Unapproved drugs are not generic medications, and neither their safety nor their efficacy can be assured.

 Show all related FDA Basics Questions

The FDA website also contain the following:

• WebLearn Course: Bringing an Unapproved Drug into Compliance (Estimated course time: 90 minutes)
• Measures Undertaken to Address Concerns about Marketing of Unapproved Drugs (Podcast)
• FDA's Action Against Marketing Unapproved Drugs (Podcast)
• Unapproved Drugs Video

All the above can be found here.

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.