Drugs
80% of API manufacturers are located outside the United States
At least 40% of drugs on U.S. shelves come from overseas.
Pharmaceutical product imports increased at nearly 13% per year from 2005-2011
Challenges presented by globalization
• More dispersed facilities supplying global market
• Increasing volume of imported products
• More outsourcing of manufacturing
• Greater complexity in supply chains
• Imports coming from countries with less developed
regulatory systems
• Greater opportunities for economic fraud
Things FDA is doing
Partner with foreign counterparts to
create global coalitions of regulators
focused on ensuring and improving
global product safety
Build global data-information systems
and networks and proactively share data
with peers
Expand intelligence gathering, with an
increased focus on risk analytics and
thoroughly modernized IT capabilities
Effectively allocate agency resources
based on risk, leveraging the combined
efforts of government, industry and
public and private third parties
facts obtained from FDA here