On the heels of a recent report released by Rep. Markey (D-MA), the congressman outlined legislation he will introduce to require the Food and Drug Administration (FDA) to regulate drug compounding facilities. This legislation is a response to the recent deadly meningitis outbreak.
Responding in a statement to Reuters, FDA Commissioner Margaret Hamburg said, "Over the years, there has been substantial debate within Congress about the appropriate amount of FDA oversight and regulation of compounding pharmacies. But unfortunately, there has been a lack of consensus and many challenges from industry. As pointed out in the report from Congressman Markey, FDA's authority over compounding pharmacies is more limited by statute than with drug manufacturers." However, at least one advocacy group has questioned whether the shortcomings that led to the outbreak are rooted in FDA's authority or in its employment of existing authority.
Other members of Congress are expected to also introduce legislation concerning oversight of compounding pharmacies.