Originally tasked to inspect food and remedies made and sold in a newly-industrialized America, the FDA said today it will begin to rely on collaboration with other regulators, data-sharing and third-party auditors to safeguard the “global bazaar” of food and drugs that now feeds into U.S. homes each year.
In a report, “Pathway to Global Product Safety and Quality,” the FDA lays out the problem: cost pressures and better transportation technology have led to the move of much food and drug-ingredient production off-shore, while the agency charged with keeping that supply safe remains scaled and funded at a domestic level.
The report delineates a critical new reality: “a U.S. company” doesn’t mean necessarily made in the U.S. (of course, the J&J recall-a-palooza reminds us that U.S. operations are far from immune to manufacture safety risks.). U.S. import of FDA-regulated products has grown 13 percent per year recently, and about 80 percent of APIs are now made overseas. And this sea change isn’t unique to food and drugs. “Some estimates predict that by the end of 2010, more than 40 percent of the final assembly in the consumer goods and life sciences industries will be performed outside of the producer’s home country, due largely to the lower cost of production," the report says.
So to meet those radically different demands, U.S. regulators must somehow go global, too, minding significant infrastructure and resource restraints.
The report expands on the four “building blocks” FDA deputy commissioner John Taylor laid out for dealing with import safety at the Pew Health Group’s After Heparin conference in March.
Here’s a topline summary of the four-part tack:
1) Bring together global coalitions of regulators dedicated to building and strengthening the product safety net around the world.
2) Build proactive and real-time data sharing system to help these networks of regulators access important safety and monitoring info across worldwide markets.
3) Modernize its IT systems and risk analytics, and build its expert staffing capacity in those areas.
4) Leverage government, industry, and public-private partnership to expand oversight capacity, including use of third-party auditors.
The FDA called that last one “one of the most fundamental changes that FDA will undertake,” and indeed, developing and verifying systems and checks to make third-party auditors are a comparable and reliable set of eyes and ears will be a sizable challenge.
But this report is thoughtful evidence that FDA understands those challenges well, and the monumental risk of sticking with the sole-guardian approach of the 20th century.
You can read the full report here.
--Kate Petersen, PostScript blogger