August 19, 2013

Global Supply Chain Highlighted in FDA Public Meeting Discussing FDASIA's Title VII

globalmap.pngEarlier 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the higher penalties for counterfeit drugs, the proposed rule for the administrative detention of drugs, and the draft guidance on penalties for manufacturers that refuse, delay, limit, or deny FDA inspections as key new developments that should help FDA secure the safety and integrity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.

Taylor stated that the "[b]order can no longer be the primary line of defense," and that the agency needs to be more proactive to address supply issues going forward. Part of FDA's transformation will need to include more support for and better collaboration with foreign regulatory agencies. For example, Taylor praised FDA's decision to support the World Health Orgaization's ("WHO's") global monitoring and surveillance system. Yet Taylor also recognized the need for FDA to collect, share, and understand information. By understanding, Taylor explained, he means that FDA needs to use this information to identify the weakest links in the drug supply chain and ensure that adequate resources, time, and attention are dedicated to those links.

Following Taylor, Susan S. de Mars, Senior Advisor, Office of Global Regulatory Operations and Policy, provided an overview of FDASIA Title VII and FDA's implementation approach. De Mars recognized that one of the challenges facing the implementation of these Title VII provisions is that there is no funding attached to the provisions, unlike some of the other FDASIA provisions. Then Howard R. Sklamberg, Director, Office of Compliance, CDER, addressed FDA's evolving approach to pharmaceutical quality. Sklamberg recounted how FDA's initial mission was quality but in recent years the quality of the drug supply has declined, which has been linked to various drug shortages. Sklamberg advocated for the need to provide clear standards, clear policy, and clear guidance so that manufacturers know what needs to be done, e.g., update aging facilities. Rather than "firemen putting out the fires," FDA is trying to encourage companies to "design the fire resistant building in the first place." For example, FDA is working with various stakeholders to come up with metrics such as batch failure rates, so FDA can compile aggregate industry data and better target its inspection resources. Industry, therefore, will be incentivized to have lower batch failure rates to make an FDA inspection less likely.

The morning concluded with input from Congress, industry, and public-interest. Keith Flanagan, Senior Regulatory Counsel, Office of Regulatory Affairs (and former senior Health Council on the Senate Health, Education, Labor, and Pension Committee) detailed FDASIA's genesis, beginning with how the heparin tragedy ignited Congress to respond. Martin Van Trieste, Treasurer and Past Chair of Rx-360, described how industry responded to heparin events and praised FDASIA as "a step forward towards a holistic approach to improving the integrity of the supply chain" and leveling the global playing field. Alan Coukell, Senior Director, Drugs and Medical Devices, the Pew Charitable Trust concluded the morning's speakers, explaining how in most instances, the public's knowledge of the drug quality and supply issues was relatively low, which is "a testament to the fact that most of the time you never have to worry about the drug quality." Coukell recognized that while many companies are already taking steps to improve the process, FDA must provide enough oversight and incentives that no one is cutting corners because, "any supply chain like any chain is only as strong as its weakest link."