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.
More information on drug safety is available at www.pewhealth.org/drugsafety.
The Pew Charitable Trusts (www.pewtrusts.org) is driven by the power of knowledge to solve today's most challenging problems. Pew applies a rigorous, analytical approach to improve public policy, inform the public, and stimulate civic life. We partner with a diverse range of donors, public and private organizations, and concerned citizens who share our commitment to fact-based solutions and goal-driven investments to improve society.
Contact: Linda Paris, The Pew Charitable Trusts, 202.540.6354, after hours 202.365.3343.
/PRNewswire-USNewswire - Sept. 28, 2013/
SOURCE The Pew Charitable Trusts
