FDA Deputy Commissioner for Global Regulatory Operations and Policy, Deborah Autor testified before the Senate regarding the safety of the pharma supply chain. During her testimony, she asked for additional FDA authority in key areas:
- Authority to promulgate enforceable standards for a national track and trace system
- Authority to refuse products from a foreign manufacturer that has refused or delayed an inspection
- Authority to issue mandatory recalls of drug products [Bet you thought they already had that didn't you? Nope.]
- Congress was also asked to legally require drug manufacurers to report drug shortages, contaminaton and cargo thefts to the FDA
Senator Barbara Mikulski (D-MD) backed Autor's comments on supply chain security by saying, "This issue needs to be elevated to a national security, homeland security, and a criminal level....so that American people that if they take [a drug], it will be okay."
Posted by Bruce Lehr Sep 16th 2011.