Food & Drug Administration Admits It Could
Food & Drug Administration (FDA) Commissioner Margaret Hamburg testified before the U.S. House Energy and Commerce Committee’s Oversight panel about the agency’s actions leading up to the outbreak of meningitis that was linked to a compounding pharmacy last year and admitted that she regretted that the FDA did not do more and was not more directly engaged.
She also acknowledged that the FDA had stopped conducting routine inspections of compounders as it developed a guidance documents for their regulation. The FDA had stopped inspections because of conflicting court rulings on its authority and it was concerned that if a compounder challenged its ability to conduct an inspection a Court could reduce its authority even further.
For more information, please see FDA Head Admits Missteps In Run-Up To Meningitis Outbreak (Note: Subscription required to view full article)