The drug development, production, and distribution landscape in the United States has changed dramatically in recent years, expanding the FDA’s responsibilities across new borders (and requiring lost of interpreting services). According to recent statistics, up to 40 % of the drugs in the United States are imported, and up to 80% of the active pharmaceutical ingredients in those drugs are produced abroad. This globalization, along with increased outsourcing, has posed new challenges that requires the FDA to refocus its drug review process.
Interpretation Services and New Enforcement Penalties
According to agency officials, the FDA plans to overhaul its enforcement approach to reflect the impact of globalization. It will partner more with foreign counterparts (using interpretation services, of course), streamline inspections and recalls, and use stricter criminal sanctions to deter noncompliance. The recent opening of offices in China and India is a reflection of the need for a greater global presence. New strategies to secure the global supply chain by ensuring that drugs are manufactured and distributed according to established quality standards are to be implemented by 2015.
The FDA also plans to continue its efforts to develop standards for biologics and the vaccine qualification process, on which global access to vaccines is dependent. Among the FDA’s goals are to promote global research and information‐sharing (which will require plenty of interpretation services) to address emerging disease threats; to facilitate global access to vaccines and biological products related to critical health needs; and to harmonize regulatory standards for new biologics to promote global public health.
In summary, the FDA’s current strategies are primarily aimed at meeting the new challenges posed by globalization, with a focus on implementing better methods to facilitate global access to safe and effective products.
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