Pew Applauds House Passage of Landmark Legislation to Enhance Drug Safety
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.
Allan Coukell, senior director of drugs and medical devices at The Pew Charitable Trusts, said bipartisan support in both the House and the Senate was strong, and thanks several lawmakers as champions for the bill: Senate Committee on Health, Education, Labor and Pensions chairman Tom Harkin (D-IA) and ranking member Lamar Alexander (R-TN), House Energy and Commerce Committee chairman Fred Upton (R-MI), ranking member Henry Waxman (D-CA), Health Subcommittee Chairman Joe Pitts (R-PA) and ranking member Frank Pallone (D-NJ).
"At a time when it often seems difficult for Congress to achieve bipartisan progress, this victory stands out as a genuine accomplishment. Too many people have died or suffered terrible illness and injury when counterfeit drugs or other unsafe medicines have been introduced into the drug supply chain, and the House has taken strong action to meet that challenge. We urge the Senate to pass it as quickly as possible and send it to the President for his signature," said Coukell. "This landmark legislation will establish a long-awaited national system to electronically track the drugs distributed in this country
and represents a major improvement in protecting patients and safeguarding our drug supply."
Title II, Drug Supply Chain Security, would establish a national standard of tracing requirements from manufacturers to wholesale distributors to pharmacies to patients. The provision has received broad support from patient and industry groups that helped shape it over the past two years. Coukell said bipartisan support for these provisions was particularly strong, and he singled out four additional lawmakers for their work: Sens. Michael Bennet (D-CO) and Richard Burr (R-NC), and Reps. Bob Latta (R-OH) and Jim Matheson (D-UT).
This legislation also includes a title which would strengthen the oversight system for large sterile compounding facilities that compound drugs under the regulatory supervision of the Food and Drug Administration.
"The terrible impact lingers from last year’s fungal meningitis outbreak, which was caused by tainted injections from a compounding facility," Coukell said. "Nearly 750 patients developed meningitis or infections around the spine and 63 people died. Many still struggle with complications. We know that this outbreak was by no means an isolated incident. The legislation passed in the House is a step forward. It does not address every risk, but it does clarify the authority of the Food and Drug Administration, and creates a new category of facilities that will be held to a higher standard in the manufacturing of compounded drugs."
Coukell noted that the compounding legislation was also a bipartisan effort, and he recognized Sens. Al Franken (D-MN) and Pat Roberts (R-KS), along with Reps. Morgan Griffith (R-VA), Gene Green (D-TX) and Diana DeGette (D-CO), for their contributions to the bill.
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
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. More info
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. 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
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