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
Senior Director, Drugs and Medical Devices , The Pew Charitable Trusts
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Allan Coukell is senior director of drugs and medical devices, overseeing Pew’s initiatives related to drug and medical device innovation and safety, medical conflicts of interest, the pharmaceutical supply chain, pharmacy compounding, antibiotics, prescription drug abuse, the Food and Drug Administration, and specialty drugs, and other efforts related to health costs and care delivery.
Before joining Pew, he practiced as a clinical pharmacist in oncology at the London (Ontario) Health Sciences Center and the Ontario Regional Cancer Center, served as a senior medical writer and editor with the medical journal publisher Adis International, and covered health and science as a reporter and producer for WBUR (NPR) in Boston and Radio New Zealand.
He is vice chair of the Medical Device Innovation Consortium and a board member of the Reagan-Udall Foundation for the FDA. He served as a consumer representative on the FDA’s Cardiovascular and Renal Drugs Advisory Committee.
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
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
Pew and the Infectious Diseases Society of America applaud Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) for their leadership in supporting the creation of the Limited Population Antibacterial Drug (LPAD) pathway. Once put in place, LPAD would expedite patient access to critically-needed antibiotics to treat serious or life-threatening infections for which there are currently inadequate treatment options.More info
Pew and the Infectious Diseases Society of America applaud U.S. Representatives Phil Gingrey (R-GA) and Gene Green (D-TX) for their leadership in supporting the creation of the Limited Population Antibacterial Drug (LPAD) pathway. Once put in place, LPAD would expedite patient access to critically-needed antibiotics to treat serious or life-threatening infections for which there are currently inadequate treatment options.More info
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