FDA outlines next steps to ensure safe products

Growth in imports of FDA-regulated products and the complexity of the global supply chain are the impetus for some strategic thinking at the FDA. The agency shared this thinking in a report issued yesterday, Pathway to Global Product Safety and Quality.

"A dramatic change in strategy must be implemented," said FDA Commissioner Margaret Hamburg in a statement. "The FDA must further collaborate to close the gap between our import levels and our regulatory resources."

The report describes four components of the strategy: more partnering with fellow regulators worldwide; data information "systems and networks" to aid collaboration among them; additional information-gathering and analysis capabilities focused on risk analytics and IT; and greater reliance on industry and third parties.

The FDA strategy anticipates increased productivity among developed countries as they compete with emerging markets. Another factor is the ongoing globalization of the supply chain: "Today, a typical U.S. manufacturing company relies on more than 35 different contract manufacturers around the world," said Hamburg. In addition, manufacturers are adopting "new manufacturing processes and emerging technologies for use in an increasingly complex operating environment."

The regulator has already boosted its inspection of foreign manufacturing plants, increasing them by 27% between 2007 and 2009. It has also opened international office and collaborated with regulators in the EU and Australia on drug inspections, worked to harmonize drug regulation through the International Conference on Harmonization, and joined the Pharmaceutical Inspection Cooperation/Scheme (PIC/S).

- see the FDA's release
- here's the document

Suggested Articles

Novavax has inked a $60 million contract with the U.S. Department of Defense to help fund U.S.-based manufacturing of its COVID-19 vaccine candidate.

Vaccine maker Inovio has accused a longtime manufacturing partner of hampering its efforts to produce 1 million doses of a potential COVID-19 vaccine.

Roche's global manufacturing leader Pierre-Alain Ruffieux will take the reins and oversee the Moderna COVID-19 vaccine collaboration.