Drug manufacturers and distributors work together in a robust system to deliver high-quality products, but our pharmaceutical supply has become increasingly complex in recent years. Medicines originate in factories all over the world, moving into the American marketplace through supply chains that can involve numerous processing plants, manufacturers, suppliers, brokers, packagers and distributors.
This interactive graphic presents and overview of today's globalized pharmaceutical supply chain and examines vulnerabilities that have allowed substandard and counterfeit products to enter the system.
On Nov. 18, 2013, Congress passed the landmark Drug Quality and Security Act, bipartisan legislation to safeguard the U.S. pharmaceutical supply from counterfeit and contaminated drugs. The act creates a national system to track and authenticate prescription medications as they progress from the manufacturer to the patient. It also addresses the risks posed by drugs made by large-scale compounding pharmacies. More info
The U.S. Senate on Monday approved a bill designed to prevent the type of quality control problems that led last year to a deadly outbreak of fungal meningitis traced to a tainted pharmaceutical mixed by a Massachusetts pharmacy. More info
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.
A bill that would give the Food and Drug Administration more power to police compounding pharmacies passed its final hurdle in Congress on Monday, in what experts said was an important step to a safer drug supply in the United States. 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.
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.
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.
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.
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.
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.
"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."
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.
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.
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.