Letter

Letter to Congressional Leadership Supporting Compounding and Track and Trace Legislation

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The Pew Charitable Trusts sent a letter to the leadership of the Senate Health, Education, Labor and Pensions, or HELP Committee and the House Committee on Energy and Commerce, urging the committees to pass proposed legislation to implement both a "track and trace" system for the U.S. pharmaceutical distribution supply chain and for enhanced federal oversight of compounding pharmacies.

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Both provisions are important to ensure prescription drugs in the U.S. are safe, effective, and of the highest quality. In the letter, Pew and its partners thanked HELP Chairman Sen. Tom Harkin (D-IA) and Ranking HELP Member Sen. Lamar Alexander (R-TN), along with their counterparts in the House, Chairman Fred Upton (R-MI) and Ranking Member Henry Waxman (D-CA) for their efforts to date, and pressing them to seize the opportunity to move this bipartisan, bicameral legislation forward.

The letter was also signed by AARP, American Medical Student Association, American Public Health Association, American Society of Health-System Pharmacists, Community Catalyst, Fight Colorectal Cancer, International Myeloma Foundation, Lymphoma Research Foundation, National Association of County and City Health Officials, Ovarian Cancer National Alliance, PennPIRG, PIRGIM, The Pew Charitable Trusts, Susan G. Komen Advocacy Alliance, TexPIRG, Trust for America's Health, and U.S. PIRG.


September, 20, 2013 

The Honorable Tom Harkin                                                  
Chairman                                                                               
Committee on Health, Education, Labor and Pensions         
U.S. Senate                                                                           
Washington, DC 20510   

The Honorable Fred Upton
Chairman
Committee on Energy and Commerce
U.S. House of Representatives
Washington, DC 20510

The Honorable Lamar Alexander                                          
Ranking Member                                                                   
Committee on Health, Education, Labor and Pensions         
U.S. Senate                                                                            
Washington, DC 20510  

The Honorable Henry Waxman
Ranking Member 
Committee on Energy and Commerce 
U.S. House of Representatives                                           
Washington, DC 20510

VIA ELECTRONIC MAIL

Dear Chairman Harkin, Ranking Member Alexander, Chairman Upton and Ranking Member Waxman:

As organizations working to protect the public's health and improve patient safety, we thank you for your work to advance important policy that strengthens pharmaceutical compounding standards in tandem with securing the U.S. drug supply.

This week marks the one year anniversary of the first reported deaths associated with the deadly outbreak of fungal meningitis caused by contaminated spinal injections made by a compounding pharmacy. Congress cannot allow additional patients to be harmed by gaps in oversight, and we cannot afford to miss this singular opportunity to hold large facilities that compound high-risk products accountable to robust quality standards.

Similarly, the pharmaceutical distribution system must be secured against diverted and counterfeit medicines. A strong national unit-level serialization and traceability standard with meaningful verification must be put into place to keep unsafe medicines from reaching consumers and patients. Without such a system to track and authenticate drugs at the unit level as they move from manufacturer to wholesaler to pharmacy, patients continue to be placed at risk from compromised pharmaceutical products.

Nearly every American family depends on medicines to prevent illness and treat disease, and they deserve assurances that their prescription drugs are safe, effective, and of the highest quality. This is a unique opportunity to move bipartisan and bicameral legislation forward that shores up critical gaps in oversight and quality standards for large-scale compounding facilities as well as strengthens the security of the U.S. drug supply. We commend your efforts to date, and urge you to finish your important work to pass legislation that promotes and protects the public's health.

AARP
American Medical Student Association
American Public Health Association
American Society of Health-System Pharmacists
Community Catalyst
Fight Colorectal Cancer
International Myeloma Foundation
Lymphoma Research Foundation
National Association of County and City Health Officials
Ovarian Cancer National Alliance
PennPIRG
PIRGIM
The Pew Charitable Trusts
Susan G. Komen Advocacy Alliance
TexPIRG
Trust for America's Health
U.S. PIRG