Sept. 20, 2013
The Honorable Tom Harkin
Chairman
Committee on Health, Education, Labor and Pensions U.S. Senate
Washington, DC 20510
The Honorable Lamar Alexander
Ranking Member
Committee on Health, Education, Labor and Pensions U.S. Senate
Washington, DC 20510
VIA ELECTRONIC MAIL
Chairman
Committee on Health, Education, Labor and Pensions U.S. Senate
Washington, DC 20510
The Honorable Lamar Alexander
Ranking Member
Committee on Health, Education, Labor and Pensions U.S. Senate
Washington, DC 20510
VIA ELECTRONIC MAIL
The Honorable Fred Upton
Chairman
Committee on Energy and Commerce U.S. House of Representatives Washington, DC 20510
The Honorable Henry Waxman Ranking Member
Committee on Energy and Commerce U.S. House of Representatives Washington, DC 20510
Chairman
Committee on Energy and Commerce U.S. House of Representatives Washington, DC 20510
The Honorable Henry Waxman Ranking Member
Committee on Energy and Commerce U.S. House of Representatives Washington, DC 20510
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.
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
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
No comments:
Post a Comment