Allan Coukell, senior director of drugs and medical devices, testified before the U.S.-China Economic and Security Review Commission on the global pharmaceutical supply chain security and the importance of the newly passed Drug Quality and Security Act.More info
Allan Coukell, senior director of drugs and medical devices, sent a letter to Senators Tom Harkin and Lamar Alexander in support of S.959, The Pharmaceutical Quality, Security and Accountability Act.
If passed, the bipartisan legislation would improve patient safety by enhancing the security of the drug supply chain.
July 29, 2013
The Honorable Tom Harkin
135 Hart Senate Office Building
Washington, DC 20510
The Honorable Lamar Alexander
455 Dirksen Senate Office Building
Washington, DC 20510
Dear Chairman Harkin, and Ranking Member Alexander,
I write on behalf of The Pew Charitable Trusts, an independent research and policy organization, to express support for S.959, The Pharmaceutical Quality, Security and Accountability Act. This bipartisan legislation will improve patient safety by meaningfully enhancing the security of the drug supply chain. This legislation will also take steps to improve federal oversight of certain aspects of pharmacy compounding.
Congress has been trying to address vulnerabilities in the U.S. pharmaceutical supply since it passed the Prescription Drug Marketing Act of 1987. S.959 is an important improvement over the status quo by ensuring there will be a national unit-level serialization and traceability system to track the movement of drugs throughout the entire supply chain in 10 years.
Congress has also long struggled with how to regulate the growing pharmacy compounding industry. This bill recognizes that the industry has changed significantly over the last several decades and attempts to mitigate the risks associated with large-scale production of sterile drugs by bringing under federal oversight any facility that produces (1) sterile products, (2) without, or in anticipation of, a prescription, and (3) sells those products into interstate commerce. This addresses certain high-risk facilities while leaving traditional pharmacy dispensing essentially untouched. The safety of compounded drugs is a critical public health issue, and the failure of the status quo is illustrated by numerous incidents, including the recent fungal meningitis outbreak that has cost so many lives. The time for Congress to act is now.
Thank you again for your bipartisan commitment to improving the safety of the U.S. drug supply by addressing gaps in both our drug distribution security system and the oversight of pharmacy compounding. We would also like to thank Senator Burr and Senator Bennet as leaders on drug supply chain security and Senator Roberts and Senator Franken as champions for the compounding provisions of the bill. We would also like to thank all of your staff for their dedication and professionalism. We applaud your efforts to date, and we look forward to continue working with you to make this legislation as strong as possible on behalf of all consumers.
Senior Director, Drugs and Medical Devices
The Pew Charitable Trusts
- Date added:
- Jul 30, 2013
The House Energy and Commerce Subcommittee on Oversight and Investigation held a hearing on Feb 16 entitled "Counterfeit Drugs: Fighting Illegal Supply Chains." Elizabeth Jungman, director of drug safety and innovation testified on counterfeit drugs the importance that newly passed Drug Quality and Security Act will have on the safety of the U.S. pharmaceutical supply chain.
The following case studies illustrate breaches to the pharmaceutical supply chain—the route a drug travels from its raw material origins to the delivery of a finished medicine. These examples, all of which are discussed in Pew Health Group’s report After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs, demonstrate the different ways in which contaminated, fake, or otherwise unsafe medicine can reach patients, and underscore the need for reform.More info
The landmark Drug Quality and Security Act was signed into law in late 2013 to address these risks and to create a new national framework for securing the drug distribution supply chain. Title II of the law, the Drug Supply Chain Security Act, establishes a national system to enable supply chain partners and regulators to trace back each package of a drug from the pharmacy where it is dispensed to the manufacturer.More info
On Nov. 27, 2013, President Barack Obama signed the landmark Drug Quality and Security Act, a new law designed to improve safety within the U.S. pharmaceutical supply by addressing these risks. Title I of the act contains important updates to oversight systems for pharmaceutical compounding. Compounding—the creation of customized medicines to meet patients’ unique needs—is traditionally practiced by pharmacies and regulated by state authorities. Over the years, this activity has expanded to include companies that compound medicine on a large scale but do not undergo the same scrutiny given to pharmaceutical manufacturers.More info