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Anti-Counterfeiting


FDA MedWatch Web site

 

HDMA and our member companies have been strong and consistent advocates for ensuring a safe and secure supply chain, with a long history of working closely with the U.S. Food and Drug Administration, the U.S. Drug Enforcement Administration, and other federal and state law enforcement agencies. Additionally, HDMA members are continually reviewing procedures and systems in an effort to ensure that the drugs they receive and distribute are the genuine product. HDMA and its members have been both active and effective in alerting and in educating the industry and policymakers about their obligations under the law and making sure these obligations are met by the established deadlines.

Like the Food and Drug Administration’s Counterfeit Drug Task Force, HDMA believes the overall approach to solving the counterfeit drug issue must be multifaceted. HDMA has identified four key issues we believe are the cornerstones to effectively combating the serious threat of counterfeit drugs:
  • Strengthening and making uniform licensing procedures and enforcement
  • Stiffer penalties for knowingly trafficking in counterfeit drugs and committing related fraudulent acts
  • Technology-based solutions
  • A commitment to “best practices” by all members of the supply chain.

HDMA and its members have a strong commitment to anti-counterfeiting solutions. HDMA is a member of the Partnership for Safe Medicines, a diverse network of organizations concerned by the consumer safety threats posed by the purchase and use of unapproved, counterfeit, substandard, mishandled or otherwise unsafe medicines. For more information on the Partnership and on safety measures consumers can use to protect themselves, click here.

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General Information

  • Click here to read Second Circuit Court of Appeals Summary Order in RxUSA v. HHS/FDA on PDMA Rule, July 11, 2008
  • Click here to read HDMA written comments on the FDA Anti-Counterfeit Drug Initiative, February 24, 2006
  • Click here for John Gray's testimony at the FDA Counterfeit Drug Task Force Public Workshop/Vendor Display
  • Click here for Lisa Clower's testimony at the FDA Counterfeit Drug Task Force Public Workshop/Vendor Display
  • Click here for Scott Melville's testimony at the FDA Counterfeit Drug Task Force Public Workshop/Vendor Display
  • Click here for HDMA President and CEO John Gray's Testimony before the Senate Health, Education, Labor and Pensions Committee
  • Read HDMA Comments on the FDA’s Anti-Counterfeit Interim Report

HDMA Guidelines for Distribution System Security
Federal Activities

Counterfeit Alert Network (CAN Network)

Press Releases

  • HDMA Press Release—HDMA Applauds Congressmen Buyer (R-IN) and Matheson (D-UT) for Introducing Uniform Federal Pedigree Requirements to Further Enhance Patient Safety, Supply Chain Security—April 21, 2008
  • HDMA Press Release—HDMA Applauds NCPA, FBI LEEDA and Purdue Pharma for Launching New Security Initiative—April 1, 2008
  • HDMA Press Release—HDMA Supports Administration's Call to Combat Illegal Online Sales of Prescription Medicines—March 3, 2008
  • HDMA Press Release—HDMA Commends Congressional Enactment of Food and Drug Administration Amendments Act (H.R. 3580)—September 21, 2007
  • HDMA Press Release—HDMA Supports the Counterfeit Drug Prevention Act of 2007 as a Vital Measure to Further Ensure Patient Safety, Deter Criminal CounterfeitingFebruary 8, 2007
  • HDMA Press Release—HDMA Partners with Rxpatrol to Prevent Prescription Drug Counterfeiting, Pharmacy Theft—June 20, 2006
  • HDMA Press Release—HDMA Commends FDA for Continued Strong Commitment to Ensuring Patient Safety, Medicine Supply Security—June 9, 2006
  • HDMA Press Release—The Healthcare Distribution Management Association Joins the Counterfeit Alert Network — May 12, 2006
  • HDMA Press Release—HDMA Continues The Fight Against Criminals Who Threaten Public Safety With Counterfeit Drugs — May 9, 2005
  • HDMA Press Release—HDMA Commends Department of Justice for Arrests Related to Sales of Illegal and Unapproved Drug — April 22, 2005
  • HDMA Press Release—HDMA Calls For Continued Emphasis On Patient Safety and Integrity of the U.S. Pharmaceutical Supply Chain, in Response to Release of HHS Drug Importation Task Force Report —December 21, 2004
  • HDMA Press Release—HDMA Applauds FDA Final Counterfeit Report—February 18, 2004

Links


Contacts
Liz Gallenagh
Vice President, Government Affairs and General Counsel
703-885-0233
lgallenagh@hdmanet.org

Anita Ducca
Vice President, Regulatory Affairs
703-885-0240
aducca@hdmanet.org

Kristen Freitas
Senior Director, Federal Government Affairs
703-885-0232
kfreitas@hdmanet.org

 
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