What role does the US Food and Drug Administration (FDA) have to play in promoting advanced manufacturing in the United States, if any?
In a 12 December 2013 hearing before the House Committee on Oversight and Government Reform, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), argued that while manufacturing may be shifting overseas, the factors behind those moves have less to do with FDA than with market-driven forces.
Approximately 40% of finished pharmaceuticals and 80% of active pharmaceutical ingredients (APIs) come from overseas, Woodcock said. Reasons for the shift from US-based production to overseas production included environmental regulations, the utilization of low-cost labor forces and the cost of building manufacturing facilities.
However, as noted by Woodcock and several legislators, this shift has also created new safety liabilities within the pharmaceutical supply chain. Woodcock noted the 2008 case of contaminated heparin, which had been sourced from China, as being one example of how foreign-sourced products can potentially harm consumers. But at the same time, Woodcock noted that US consumers and FDA have few options in some cases, including with heparin. "There was no adequate alternative source [for heparin outside of China]," she recalled. The agency ultimately devised screening tests to ensure that imported heparin was safe for use.
And as the US has continued to deal with drug shortages, some caused by deficient manufacturing operations here in the US, FDA has increasingly turned to foreign-based suppliers to meet the needs of desperate healthcare providers and consumers alike. "Examples of critical drugs currently or recently in shortage with an active ingredient and/or finished goods sourced primarily from overseas include propofol, heparin, and Tamiflu," Woodcock added.
This reliance on foreign-sourced pharmaceuticals, she conceded, "create[s] ongoing vulnerabilities."
A (Small) Role to Play
So what can be done to bolster the safety of the US supply chain? Can advanced pharmaceutical manufacturing ever be brought back to the US, and does FDA have a role to play in ensuring that it is?
Woodcock seemed slightly optimistic that FDA could play a role, though she admitted that many of the factors she talked about-environmental, labor and building costs-were beyond the scope of FDA's regulatory authority.
Where FDA could really make an impact, she said, was in promoting "development of novel manufacturing technologies in collaboration with academic and industry experts."
For example, new continuous manufacturing techniques could remove the need for large factories, allowing production facilities to be smaller and located closer to end markets, "thus reducing the need for transcontinental shipping of components."
FDA has also been working with outside groups to better understand aspects of manufacturing science, though she noted that these efforts are "relatively small in scale, given the impact and criticality of the drug supply."
CDER is also making efforts to streamline and simplify its regulation of current good manufacturing practices, which could eventually bring down costs for facilities, thereby reducing the incentive to relocate abroad, she said.
"In summary, FDA has been working diligently for over a decade, in collaboration with the pharmaceutical industry, to improve drug manufacturing," Woodcock concluded. "These new ways of making drugs could, with the proper strategies, revitalize pharmaceutical manufacturing in the United States."