FDA is overhauling its strategy to meet global regulatory-inspection requirements

Pharmaceutical CommercePharmaceutical Commerce - May/June 2011

New strategy involves collaboration with overseas inspectorates; risk-based prioritization of inspections

Whether or not FDA could ramp up its overseas inspections of drug-manufacturing facilities at a pace commensurate with the growth of imports from them—or whether Congress understands the scope of the responsibility it keeps mounting on FDA’s shoulders—the reality is that the FDA inspection system has fallen far behind the current manufacturing and trading marketplace, for both food and drugs, as well as medical devices. In 2006-7, after receiving increased funding, FDA was able to increase its inspections of foreign drug manufacturing facilities by 27%--but that only scratches the surface of thousands of facilities in Asia and elsewhere. More recently, Congress imposed a duty of inspecting 19,200 more food-exporting facilities by 2016, through the FDA Food Safety Modernization Act, and requires FDA to double the number of foreign inspections each year, a task FDA says is “impossible” without a “substantial increase in resources of a complete overhaul in the way it operates.” As FDA Commissioner Margaret Hamburg notes, imports of FDA-regulated products have quadrupled since 2000, and are growing at a 15%yr annual rate.

So, in its just released “Pathway to Global Product Safety and Quality,” FDA is announcing a new approach, one that depends much more on partnering and data-sharing. The key goals:

1. The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.

2. The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.

3. The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.

4. The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.

The inability of FDA to keep pace with overseas production is well known; as it notes, GAO has been chiding it for years for not increasing foreign inspection, but as of today, “It would take an estimated nine years for FDA to inspect every high priority pharmaceutical facility just once.” More recently GAO noted that while FDA has inspected 90% of domestic facilities, it had only inspected 36% of foreign ones (or less; the numbers of establishments are not definitively known).

Some statistics to conjure with: it is well known that 80% of APIs are currently imported to the US; at the same time, the proportion of imported finished drugs is 28%. Meanwhile, medical devices are even more strongly dependent on imported sources; the proportion is 52% (all figures on a dollar basis, 2008).

The “Pathway” report cites FDA’s Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) several times as an example of how the agency is moving forward, but that program has reportedly had a troubled evolution, in development for over five years and currently deployed at only a fraction of FDA district offices. FDA says that the new global strategy will “unfold over several years,” and that it will “also look to Congress to modernize its antiquated autnorities so that FDA’s legal tools keep pace with globalization.”

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