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
On Nov. 27, 2013, President Barack Obama signed the landmark Drug Quality and Security Act, a new law to safeguard the U.S. pharmaceutical supply from counterfeit and contaminated drugs. Passed by Congress on Nov. 18 with bipartisan support, the bill 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.
The law has been supported by diverse stakeholders, including leading public health organizations, patient and consumer advocates, and members of the pharmaceutical industry.
A new tracking system for prescription drugs
|“The Drug Quality and Security Act is the product of years of hard work by lawmakers and their staff, regulators, drug companies, pharmacists, doctors, and patient and consumer advocates. And it stands as a victory of compromise and cooperation for the public good.” – Allan Coukell, senior director of drugs and medical devices, The Pew Charitable Trusts|
The U.S. drug distribution system has experienced serious breaches that have resulted in unsafe medicines reaching patients. For example, 48 people were charged in 2012 in a diversion scheme to buy an estimated $500 million worth of prescription drugs that had already been dispensed to patients, repackage them, and sell them back to pharmacies via licensed wholesalers,1 exposing patients to potentially contaminated or expired medicines. Also, in three recent instances, the U.S. Food and Drug Administration announced that a counterfeit cancer drug had been purchased by U.S. doctors and clinics.2
The Drug Quality and Security Act requires pharmaceutical manufacturers to place a unique serial number on every package of prescription drugs and mandates that each package be tracked electronically as it moves from the manufacturer to the wholesaler to the pharmacy. Companies in the supply chain can check a drug’s serial number to ensure that it is authentic.
The safety of compounded drugs
Pharmaceutical compounding—the creation of customized medicines to meet patients’ unique needs—was traditionally practiced by pharmacies and regulated by state authorities. Over the years, this activity has expanded to include companies that compound on a large scale, creating thousands of medicines and shipping them to hospitals and doctor’s offices across the country but without the same scrutiny given to pharmaceutical manufacturers.3
Contaminated compounded drugs have caused numerous deaths and injuries. The most serious outbreak, caused by the sale of a contaminated steroid injection, has been associated with 64 deaths and 751 serious illnesses as of November 2013.4
The Drug Quality and Security Act establishes a new category of FDA-regulated compounders, called “outsourcing facilities,” that will undergo regular inspections, meet more rigorous quality standards, and track and report adverse events.5 This category will give hospitals and clinics access to higher-quality compounded drugs, reducing the risk to patients. In addition, the law limits pharmacies not registered as "outsourcing facilities" to compounding drugs only based on prescriptions or in limited quantities in advance of receiving prescriptions.
1 U.S. Attorney’s Office, Southern District of New York. “Manhattan U.S. Attorney Announces Charges Against 48 Individuals in Massive Medicaid Fraud Scheme Involving the Diversion and Trafficking of Prescription Drugs,” news release, July 17, 2012, http://www.fbi.gov/newyork/press-releases/2012/manhattan-u.s.-attorney-announces-charges-against-48-individuals-in-massive-medicaid-fraud-scheme-involving-the-diversion-and-trafficking-of-prescription-drugs.
2 U.S. Food and Drug Administration, “Counterfeit Version of Avastin in U.S. Distribution,” official statement, February 14, 2012. http://www.fda.gov/drugs/drugsafety/ucm291960.htm.
3 The Pew Charitable Trusts, American Society of Health-System Pharmacists, American Hospital Association, “Pharmacy Sterile Compounding Summit: Summary of a Stakeholder Meeting” (April 15, 2013), http://www.pewhealth.org/uploadedFiles/PHG/Content_Level_Pages/Other_Resource/Compounding_report.pdf.
4 U.S. Centers for Disease Control and Prevention, “Multistate Fungal Meningitis Outbreak Investigation.” http://www.cdc.gov/HAI/outbreaks/meningitis.html.
5 The Drug Quality and Security Act of 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
On January 31, Pew submitted comments to the U.S. Food and Drug Administration in response to draft guidance on the implementation of Title I of the Drug Quality and Security Act and addressed five topics: anticipatory and office stock compounding; quality standards; FDA / state coordination; MOUs to address inordinate interstate shipment of compounded drugs; use of bulk drug substances.More info
On Nov. 27, President Barack Obama signed the landmark Drug Quality and Security Act, a law that aims to improve the safety of the U.S. pharmaceutical supply. Title I of the act contains important updates to oversight systems for pharmaceutical compounding, and on Dec. 3, the U.S. Food and Drug Administration, or FDA, released for public comment six guidance and regulatory documents for implementing the new law.More info
A small number of U.S. compounding pharmacies have begun registering with the Food and Drug Administration under new legislation designed to tighten control of the custom medication makers following a deadly outbreak of fungal meningitis linked to a pharmacy in Massachusetts.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.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