The Pharmalot Blog written by Ed Silverman posted today, October 24th, 2012 // 12:47
pm, the following:
While Congress
gathers documents and probes the compounding scandal over an outbreak of
fungal meningitis that has killed 23 people, a consumer watchdog is calling for
the US Health & Human Services Secretary Office of the Inspector General to
conduct a separate and independent investigation into the FDA over its “failure”
to regulate compounders.
In a letter this morning to HHS Secretary Kathleen Sebelius, Public Citizen accuses the FDA of making misleading statements about its regulatory authority in remarks to the media, which were subsequently reported, and failed to take action against New England Compounding Center when it was possible to do so.
The FDA “has failed to use its existing, long-established legal authority to effectively regulate the large-scale production and distribution of drugs by companies acting under the guise of compounding pharmacies,” the consumer watchdog wrote, adding that FDA officials explained claimed they lacked the necessary legal tools.
The watchdog cited remarks made by FDA commish for global operations and policy Deborah Autor, who told reporters it was “really unfortunate that it sometimes takes a tragedy” to bring about change and called on industry officials and lawmakers to adopt a new “regulatory scheme that appropriately controls the risk.”
To read the rest of this blog click here
In a letter this morning to HHS Secretary Kathleen Sebelius, Public Citizen accuses the FDA of making misleading statements about its regulatory authority in remarks to the media, which were subsequently reported, and failed to take action against New England Compounding Center when it was possible to do so.
The FDA “has failed to use its existing, long-established legal authority to effectively regulate the large-scale production and distribution of drugs by companies acting under the guise of compounding pharmacies,” the consumer watchdog wrote, adding that FDA officials explained claimed they lacked the necessary legal tools.
The watchdog cited remarks made by FDA commish for global operations and policy Deborah Autor, who told reporters it was “really unfortunate that it sometimes takes a tragedy” to bring about change and called on industry officials and lawmakers to adopt a new “regulatory scheme that appropriately controls the risk.”
To read the rest of this blog click here
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