In her testimony before the House Energy and Commerce committee on health appropriations, HHS Secretary Kathleen Sebelius called for $101 million of FDA's 2011 budget request to be used for a “medical product safety initiative” to increase inspections and “invest in tools that will enhance the safety of increasingly complex drugs, medical devices, and biological products.”
We are glad to see the Secretary recognizing the need for increased inspections – the lack of foreign inspections is a problem highlighted recently by FDA itself and the GAO, which found that FDA is able to inspect just seven percent of prioritized foreign drug manufacturing sites every year. This, despite evidence that foreign India and China alone produced close to 70 percent of the global supply of active drug ingredients in 2007 – up from just under half of the APIs three years before.
Doing the math, that means plants making U.S drugs overseas may wait well over 10 years between FDA inspections, while domestic plants are inspected every 2.7 years on average. The rate of inspection within China is even lower. If unchanged, it would take nearly 50 years to inspect all 700 or so FDA-registered Chinese drug-manufacturing sites.
Recent increases in budget appropriations for FDA have allowed the agency to begin to build its foreign inspections program, as well address structural problems at the agency like understaffing and IT capacity. But serious structural problems affecting the agency’s ability to regulate drug manufacturing and importation remain. And considering the growth rate of foreign manufacturing plants and how thinly resources must be stretched. The increased appropriations the Secretary recommends will likely still be insufficient to bring foreign inspection up to speed with domestic inspection rates.
One way to help correct for this would be to consider a user fee system as proposed in legislation introduced in both the House and Senate in the current Congress. The agency already employs user fees with drug manufacturers during the approval process, and with food and drug companies whose manufacturing violations require re-inspection. A similar user fee for general Good Manufacturing Practice (GMP) inspections inspections would help protect consumers.
Inspections alone are not the solution. FDA must find better ways to predict risk. And the agency is taking steps. For example, at the border, the agency uses PREDICT, a new web-based risk-based assessment system that incorporates inspection histories, counterfeit risk, and environmental influences. But such a system could also be used earlier in the inspection process, to target overseas manufacturing inspections before risky products ever get shipped or unloaded at the docks.
--Kate Petersen, PostScript blogger