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.
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
- HDMA Comments on the FDA Draft Guidance on the Standard Numerical Identifier —April 16, 2009
- HDMA's comments on Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs; Request for Comments; 73 Fed. Reg. 14988 (March 20, 2008) [Docket No. FDA–2008–N–0120]—May 19, 2008
- HDMA's comments on Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Comments; 73 Fed. Reg. 14991 (March 20, 2008) [Docket No. FDA–2008–N–0121]—May 19, 2008
- HDMA Recommendations for Enhancing the Domestic Prescription Drug Supply Chain
- HDMA
Comments to FDA on Anti-Counterfeit Interim Report—December
4, 2003
- Summary
of the October 15, 2003 FDA Anti-Counterfeit Public Meeting—October
15, 2003
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 Counterfeiting—February
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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