"The last thing a cancer patient should have to worry about is whether lifesaving drugs administered at a hospital are real or counterfeit.
While an individual's chance of getting fake medications is small, the unfortunate truth is that the risk is real and that the United States is underequipped to combat what experts agree is an emerging public health threat: drugs whose potency is compromised by theft or fraudulent wholesalers and manufacturers.
'The United States lacks strong, uniform national standards for licensure of pharmaceutical wholesalers, and we lack a standard system for companies to keep track of our pharmaceuticals during distribution,' said Allan Coukell, the Pew Health Group's medical director, at a March 8 congressional hearing. 'There is currently no way to check whether an individual vial or bottle is authentic or counterfeit.' ... "
- Date added:
- Mar 23, 2012
In response to final Senate passage of the Drug Quality and Security Act—legislation that establishes a national standard for tracing pharmaceuticals through the drug supply system and clarifies federal authority over pharmaceutical compounding—Allan Coukell, senior director of drugs and medical devices at The Pew Charitable Trusts, issued the following statement.More info
A year after a meningitis outbreak from contaminated pain injections killed at least 64 people and sickened hundreds, Congress is ready to increase federal oversight over compounding pharmacies that custom-mix medications.More info
It's been more than a year since a deadly fungal meningitis outbreak traced to a filthy New England compounding pharmacy put a shocking spotlight on the risks of medications mass-produced by underregulated firms.More info
Letter from Pew and The Pharmaceutical Distribution Security Alliance to Senate Leadership Calling for Passage of Track and Trace Legislation
Pew and the Pharmaceutical Distribution Security Alliance, or PDSA, PDSA have co-signed a letter asking Majority Leader Harry Reid (D-NV) and Republican Leader Mitch McConnell (R-KY) to pass The Drug Quality and Security Act (HR 3204), which would implement a “track and trace” system for the U.S. pharmaceutical distribution supply chain and enhanced federal oversight of compounding pharmacies to safeguard the nation’s drug supply against counterfeit and contaminated medicines.More info
A year after a deadly fungal meningitis outbreak tied to tainted pain shots, victims like Margaret Snopkowski say they remain devastated by the ordeal — but determined to rebuild their lives.More info
The Pew Charitable Trusts continues to call for passage of the Drug Quality and Security Act (HR 3204) in the Senate. The legislation would implement a "track and trace" system for the U.S. pharmaceutical distribution supply chain and establish enhanced federal oversight of compounding pharmacies to keep the nation’s supply of drugs and other pharmaceutical products as safe as possible and increase patient safety.More info
The following Q&A—prepared by the food and medical products programs at The Pew Charitable Trusts–helps explain how the federal government shutdown is affecting the U.S. Food and Drug Administration and other agencies and departments with responsibility to protect the public’s health.More info
The Pew Charitable Trusts thanks congressional leadership for advancing patient safety by moving forward with legislation to implement a “track and trace” system to authenticate medicines through the U.S. pharmaceutical supply chain and enhanced federal oversight of pharmaceutical compounding. The Drug Quality and Security Act (H.R. 3204) is a tremendous victory in the bipartisan effort to improve oversight and strengthen the quality and safety of drugs in the United States. The legislation passed the U.S. House September 28 and now moves to the Senate, where supporters anticipate approval.More info
"A bipartisan committee of lawmakers from the Senate and the House reached a compromise on Wednesday on legislation that would give the Food and Drug Administration greater control over compounding pharmacies. But analysts said it was still unclear whether the law would actually make drugs safer."More info
Pew and the Pharmaceutical Distribution Security Alliance, or PDSA, are advocating for legislation to establish a single, rigorous and uniform supply chain standard for all participants, and to set up a system governing all elements of the chain: product manufacturers, primary and secondary wholesale distributors, logistics providers and pharmacies.More info
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.More info
The third nationwide recall of birth control pills in six months is causing unease among Canadian women and raising questions about the quality and safety of the foreign drug plants where the medications were produced.More info