Globalization's impact
-Janet Woodcock, director, Center for Drug Evaluation and Research (CDER)
"Heparin was a wakeup call," demonstrating that we "need vigilance throughout the supply chain," said Woodcock. Solving these
issues is "going to take a lot of harmonization" given the challenges. These challenges include: an explosion of global manufacturing,
increased complexity of the supply chain, greater potential for exploitation, a global regulatory system that is still fragmented,
US erosion of inspectional coverage, and a lack of modern information technology systems.
"Globalization is taking over as the standard of the day....," added Woodcock. To move forward from here, we need "seamless,
effective global regulatory collaboration" with a worldwide safety net and increased effectiveness of inspectorates in developing
countries. We also need fully harmonized quality standards in ICH (International Conference on Harmonization) and non-ICH
regions, manufacturing modernization, harmonization of pharmacopeial stands, agreed-upon methods for supply-chain security,
and better information technology, including better automation and standardization of global inventory.
In terms of responsibility, Woodcock discussed the fact that manufacturers must take responsibility for pharmaceutical quality
of their products and for the integrity of their own supply chains. Regulators must adopt standards that ensure a safety net
and take actions against poor quality, while enabling continuous improvement. Standards and technical organizations need to
reach consensus on technical standards. Professional and technical societies must develop and update standards and disseminate
them to industry via educational opportunities.
For its part, said Woodcock, FDA is continuing with its Pharmaceutical Quality for the 21st Century initiative, intensifying
its international outreach with programs such as Beyond our Borders, and keeping track of inventory of manufacturing establishments
as well as movement of product. More efforts may crystallize after the upcoming presidential election with regard to legislation
currently circulating within Congress.
Import safety
-Jeffrey Shuren, associate commissioner for policy and planning, Office of the Commissioner
The Interagency Working Group on Import Safety, established by executive order in July 2007, issued a strategic framework
for an Import Safety Action Plan last November. We no longer want a "snapshot at the border, but rather a streaming video
feed" of when risk arrives and how we can rapidly respond, said Shuren. The goal is to have a level playing field regarding
standards, corporate responsibility, and global partnerships. Companies who are outsourcing or contracting out services need
to "trust the 'good actors' but verify their compliance and impose stiff penalties on 'bad actors,'" he said.
According to Shuren, FDA is continuing to work on "good importer practices" guidance, which will be available for comment.
Guidance may involve certification of compliance with FDA standards before imports are allowed into the United States.
