11/15/2012

The FDA needs new authority over drug compounders to prevent disasters such as the meningitis outbreak tied to tainted custom-made drugs from the New England Compounding Center, FDA Commissioner Dr. Margaret Hamburg told members of a House Energy and Commerce subcommittee. The present system "hampered our ability to act to protect patients and prevent, rather than just react to, safety concerns," Hamburg said. Several lawmakers sharply criticized the FDA, and committee Chairman Fred Upton, R-Mich., faulted the agency for not following up after finding problems years ago.

Related Summaries