Genzyme to correct manufacturing quality violations at Mass. plant
SILVER SPRING, Md. Biotech company Genzyme will pay $175 million to the federal government as part of an effort to correct problems at its factory in Allston, Mass., the Food and Drug Administration said Monday.
The FDA announced that Genzyme had signed a consent decree of permanent injunction, agreeing to correct manufacturing quality violations and to adhere to a “strict” timetable to bring the plant in line with regulations. The payment to the government is a disgorgement to make up for profits from drugs made at the factory.
“It is critical for the safety of the drug supply that companies comply with basic manufacturing standards,” FDA principal deputy commissioner Jushua Sharfstein said in a statement. “FDA takes these obligations very seriously and expects manufacturers to do the same.”
During an inspection of the plant between Oct. 8 and Nov. 13, 2009, FDA inspectors found deficiencies in its quality-control systems, leading to shortages and contaminated drugs.
The company is the sole supplier of several enzyme-based biotech drugs used to treat rare genetic disorders. These include Cerezyme (imiglucerase), for Gaucher’s disease, which causes fatty substances to build up around the digestive organs, and Fabrazyme (agalsidase beta), for Fabry disease, which causes oil and fats to build up around the eyes and kidneys, among others.
NACDS’ stance on medication adherence emphasized in NYT article
ALEXANDRIA, Va. The National Association of Chain Drug Stores has praised a New York Times article that underscored medication therapy management and the consequences of nonadherence.
The article emphasized the use of technological solutions to enhance medication adherence, and said that “[medication nonadherence] undermines even the best cost-saving and clinical intentions of evidence-based care.” These ideas are consistent with NACDS’ focus on expanding e-prescribing, fostering electronic health records and increasing access to and use of pharmacist-provided medication therapy management services, the pharmacy group said.
In response to the article, NACDS president and CEO Steve Anderson said, “The National Association of Chain Drug Stores has pledged to own the issue of medication adherence. We made this pledge because we know that pharmacists have the education and skills to work with patients to increase medication adherence rates, improve patient health and reduce overall healthcare costs.”
As previously reported by Drug Store News, an article published in the New England Journal of Medicine last month noted that more than $100 billion is spent each year on avoidable hospitalizations. The statistic is just the tip of the iceberg, the authors wrote, as the New England Healthcare Institute projected in July 2009 that $290 billion in total annual costs, or 13% of all healthcare expenditures, were caused by poor medication adherence.
CVS Caremark highlights energy-saving measures
WOONSOCKET, R.I. CVS Caremark detailed its efforts to better manage its energy consumption and reduce its carbon emissions in the company’s just-released “2009 Corporate Social Responsibility” report.
To reduce consumption at its stores, CVS Caremark focused on several initiatives in 2009, including installing more efficient lighting and new roofs designed to reflect heat, and integrating its first energy management systems.
In other moves, the company evaluated renewable energy sources, built new facilities to LEED standards and/or environmental considerations and reduced fuel consumption in its distribution networks.
Three lighting projects in the states of Florida, Michigan and Pennsylvania yielded the highest savings of 2,640 MWh, 3,480 MWh and 1,850 MWh, respectively. In addition, the retail pharmacy chain rolled out its computer-controlled energy management system in 50 stores in Florida, and will expand the system to 250 locations in 2010.
In the area of transportation, CVS Caremark has reduced the driving speed of its private fleet to 63 miles per hour, and consolidated its deliveries, which has eliminated 6,541 routes across the network. This resulted in nearly 1.2 million fewer miles driven and a savings of 218,730 gallons of fuel. It also prevented the emissions of 2,260 tonnes of CO2.