The FDA has unveiled a new strategy that it says will help it meet the challenges posed by the increased number of imports it regulates, as well as a complex global supply chain. The strategy is detailed in a report titled "Pathway to Global Product Safety and Quality."
"This report in large part is meant to frame the issue so that all of our colleagues inside the FDA and external to the FDA really understand how much the world has changed and the necessity of how much we do business in the FDA has to be dramatically transformed," agency head Margaret Hamburg said in an interview, as quoted by the New York Times. "This is something that I've been stressing as a priority from Day 1."
As the FDA's report notes, the growth in imports has been rapid. Just a decade ago, 6 million shipments of FDA-regulated goods passed through the nation's 300 ports of entry. This year, the number will quadruple to 24 million shipments. And each year over the last seven years, imports of pharmaceutical products have increased at nearly 13 percent and devices have grown at more than 10 percent.
Goods are entering the country from new and different markets, and the shift in global flows will make it difficult to identify the source of a product and to ensure that all players along the supply chain meet their safety and quality responsibilities. Furthermore, the FDA will confront increased threats of fraud, product adulteration and terrorism.
Because of these threats, the FDA is looking to transform the way it conducts business and to act globally in order to promote and protect the health of U.S. consumers. Its report includes four strategies to help it meet these goals:
- Partnering with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality;
- Developing international information systems and networks and increase data sharing and regulatory resources across world markets;
- Building in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology; and
- Increasingly leveraging efforts of public and private third parties and industry and allocate FDA resources based on risk.
Pharma supply chains suffer on regulations
FDA launches drug safety pilot program