PHARMACY

FDA undertakes TNF study

BY Drew Buono

WASHINGTON The Food and Drug Administration is conducting a safety review of tumor necrosis factor blockers, which include the drugs Enbrel manufactured by Amgen and Wyeth, Abbott Laboratories’ Humira, UCB’s Cimzia and Centocor’s Remicade.

The drugs are being reviewed for a possible association between their use and the development of lymphoma and other cancers in children and young adults treated with the drugs for juvenile idiopathic arthritis and Crohn’s disease. The drugs suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to immune system-related diseases such as JIA, and Crohn’s disease.

The agency has asked the makers of the TNF blockers approved for use in children and young adults) to supply information about all cases of cancer reported in children and young adults taking TNF blockers.

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FDA, EMEA partner on inspections program

BY Drew Buono

WASHINGTON The Food and Drug Administration and the European Medicines Agency have joined together to pilot a good manufacturing practice inspections program.

Under the bilateral agreement, the program will apply to facilities in both the U.S. and the European Union. Also, joint inspections of active pharmaceutical ingredient facilities in countries outside the U.S. and the EU will be part of the program.

The agencies will pilot a GMP information exchange covering inspection schedules and results. Information on facilities that have been inspected would be shared so the agencies could get greater inspection coverage and better identify API production sites in countries outside the U.S. and the EU.

“The collaboration on inspections should result in more effective use of resources and a higher safety level of product from third countries,” the European Commission, which lists new GMP initiatives the two agencies undertake, said.

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Study shows Mass. plan drops uninsurance rate, decreases expenses

BY Drew Buono

CHICAGO According to a study performed by the Urban Institute, the uninsurance rate for Massachusetts adults has dropped by more than half and residents were paying less in out-of-pocket health expenses, as reported by the Associated Press.

Researchers from the institute interviewed 3,000 Massachusetts residents in the fall of 2006, just before the law took effect, and conducted a second round of interviews a year later. The uninsurance rate among working age adults dropped from 13 to 7 percent. The biggest drop was among poorer residents.

The finding reflects the fact that nearly 350,000 residents have been added to the ranks of the insured in Massachusetts under the law, which created a subsidized health care program for those earning less than three times the federal poverty level.

The share of adults reporting out-of-pocket expenses of more than $500 dropped by four percent. The percent of low-income adults reporting out-of-pocket expenses of more than $3,000 fell eight percent.

In another positive finding, low-income adults were more likely to have a place to go when they were sick and were more likely to visit a doctor for preventative care.

One fear—that employers would begin dropping health coverage as the new law took effect—hasn’t materialized, according to the report.

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