FDA Shouldn’t Outsource Antibiotic Decisions

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rosa-delaurAn FDA advisory committee last month discussed the possibility of outsourcing decisions about previously approved antibiotics to a group called the Clinical and Laboratory Standards Institute, or CLSI, a nonprofit that promotes the use of standards in health care.

And Rosa DeLauro, a Connecticut Congresswoman who chairs a House subcommittee that appropriates money to the agency, worries the FDA will actually do so, The Wall Street Journal writes. “It is very troubling that the agency would consider outsourcing an essential function,” DeLauro wrote in a letter this week to FDA Commissioner Margaret Hamburg, according to the paper.

Antibiotic makers are supposed to review their drug annually to make sure labels still reflect current info about effectiveness against a particular bacteria. But the FDA has said it has found it difficult to ensure labeling for antibiotics is up to date, the paper writes, adding that CLSI’s role would be to test the drugs and ensure they still work against a particular strain of bacteria.

DeLauro is concerned because some advisory committee members were also members of CLSI. They include doctors and scientists in industry, academia and government organizations such as the Centers for Disease Control and Prevention. The group’s annual report says companies such as AstraZenca and Abbott Labs are “world-class members.”

DeLauro noted that some members of the committee with ties to CLSI were removed prior to the meeting, but not all, according to the Journal, which also wrote that DeLauro is mainly concerned that such a “critical public health issue” would be outsourced to a group that primarily develops testing standards, rather than reviewing human clinical studies.

A representative from CLSI didn’t immediately respond to the paper, which wrote the FDA will review the letter and respond directly to DeLauro.

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