"Chairman Stearns, Ranking Member DeGette, and members of the Oversight and Investigations Subcommittee, thank you for the opportunity to submit testimony about the essential steps Congress must take to protect Americans and ensure the integrity of our drug supply."
"A major focus of the Pew Health Group is identifying ways to address risks to the U.S. pharmaceutical supply chain. Last month, we hosted a two-day conference that included representatives of brand and generic pharmaceutical manufacturers, active ingredient makers, federal and state regulators, major and secondary pharmaceutical wholesalers, chain and independent pharmacies, consumer and health professional organizations and independent supply chain experts. The convening was structured around a discussion draft of a white paper entitled “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs,” which was shared with conference participants in advance."
Download the PDF to read the complete testimony from Alan Coukell.
Pew sent a comment letter to the Senate Committee on Health, Education, Labor and Pensions on the Pharmaceutical Compounding Quality and Accountability Act. This bill takes steps toward clarifying state and federal oversight of compounding, including an important increase in FDA supervision of certain activities—specifically, the compounding of sterile medicines that are shipped interstate.
More infoRepresentative Edward Markey, a Democrat from Massachusetts, on Thursday became the latest lawmaker to propose legislation that would give the U.S. Food and Drug Administration greater regulatory authority over drug compounding.
More infoOn Thursday, May 23, the House Energy & Commerce Subcommittee on Health held a hearing, entitled "Examining Drug Compounding." Gabrielle Cosel, a drug safety expert, testified on the need to clarify oversight of compounding pharmacies on the state and federal level.
More info
Public health and consumer advocacy groups are attacking Senate legislation designed to tighten oversight of specialized pharmacies such as the one at the center of this past fall’s deadly meningitis outbreak, saying it does not adequately address health risks.
More infoCopyright(c) 1996-2012 The Pew Charitable Trusts. All Rights Reserved.
[+] Feedback PHG.PRODUCTION.1.20130703.1022 (PEWSUWVMWAPP01)
