Earlier this month, FDA released the transcript of its July 12, 2013 Public Meeting on Implementation of Drug Supply Chain Provisions of Title VII of the Food and Drug Administration Safety and Innovation Act ("FDASIA"). The day-long public meeting concerned the drug supply chain provisions and was meant to discuss how the Agency means to implement those provisions, and for FDA to hear public comment about those provisions that specifically address imported drugs and importers.
The morning session opened with Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, who spoke on "The Challenges of Globalization." Hamburg praised the passage of FDASIA and recognized FDA's expanded authorities under the legislation. In a theme that was repeated throughout the morning session, Hamburg stressed that the drug supply was becoming "progressively more complex and more global" and that while FDA's mission and focus remain domestic, the reality is that the agency rapidly becoming a global agency. In fact, nearly 40% of all U.S. drugs are made elsewhere, 80% of the sites that manufacture active pharmaceutical ingredients ("APIs") are located outside the U.S, and imports are now coming in from over 150 countries. This global expansion has forced FDA to increase its collaboration with its international regulatory counterparts. The Commissioner highlighted the higher penalties for counterfeit drugs, the proposed rule for the administrative detention of drugs, and the draft guidance on penalties for manufacturers that refuse, delay, limit, or deny FDA inspections as key new developments that should help FDA secure the safety and integrity of the supply chain.
John M Taylor III, Counselor to the Commissioner and Acting Deputy Commissioner for Global Regulatory Operations and Policy, spoke next on "FDA's Globalization Strategy." Echoing the comments of the Commissioner, Taylor noted the increase in U.S. imports that has "eliminated the distinction between domestic and imported products" and recognized the trouble FDA has had keeping up with a more complex drug supply chain that involves more ingredients and more players. Threats to that supply chain include: (1) adulteration of products, (2) counterfeit products, and (3) cargo theft. In particular, Taylor noted how FDA was not prepared--both technologically and statutorily--for the alarming rise in Internet pharmacies and drug products being shipped through the mail and air courier systems.