HDMA and its member companies are 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 are 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; and,
- 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.
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- HDMA Comments on the FDA Draft Guidance on the Standard Numerical Identifier - April 16, 2009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 Comments on the FDA Anti-Counterfeit Drug Initiative - February 24, 2006
- 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
- Recommended Guidelines for Pharmaceutical Distribution System Integrity - November 6, 2003
News
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- HDMA Applauds NCPA, FBI LEEDA and Purdue Pharma for Launching New Security Initiative - April 1, 2008
- HDMA Supports Administration's Call to Combat Illegal Online Sales of Prescription Medicines - March 3, 2008
- HDMA Commends Congressional Enactment of Food and Drug Administration Amendments Act (H.R. 3580) - September 21, 2007
- 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 Partners with Rxpatrol to Prevent Prescription Drug Counterfeiting, Pharmacy Theft - June 20, 2006
- HDMA Commends FDA for Continued Strong Commitment to Ensuring Patient Safety, Medicine Supply Security - June 9, 2006
- The
Healthcare Distribution Management Association Joins the Counterfeit
Alert Network - May
12, 2006
- HDMA Continues The Fight Against Criminals Who Threaten Public Safety With Counterfeit Drugs - May
9, 2005
- HDMA Commends Department of Justice for Arrests
Related to Sales of Illegal and Unapproved Drug - April
22, 2005
- 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 Applauds FDA Final Counterfeit Report - February
18, 2004
General Information
- Click here to read Second Circuit Court of Appeals Summary Order in RxUSA v. HHS/FDA on PDMA Rule, July 11, 2008
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- 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
Testimony
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Issue Contact: Liz Gallenagh (Government Affairs), Anita Ducca (Regulatory Affairs), Kristen Freitas (Federal Affairs) |
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