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FDA failure on foreign inspections frightening

By Kirsty Barnes , 05-Nov-2007

A US government audit has confirmed the Food and Drug Administration's (FDA's) continual lack of inspection of foreign drug manufacturing plants.

The revelation is frightening considering that 75-80 per cent of all active pharmaceutical ingredients (APIs) used by US drug manufacturers are now imported, mainly from India and China, along with 40 per cent of finished dosage forms from various global locations.

 

 

 

The worrying situation has long been highlighted by the US and EU industry trade bodies - the Synthetic Organic Chemical Manufacturers Association (SOCMA) and the European Fine Chemicals Group (EFCG) - who have been campaigning for regulators to increase their inspections of foreign facilities.

 

 

 

"The Asianisation of APIs has caught regulators by surprise and now they are having to play catch up," say the organisations.

 

 

 

The new Government Accountability Office (GAO) audit added more fuel to the fire, revealing that the FDA was unable to provide inspection records for two-thirds of the 3,250 facilities that are currently believed to supply the US with pharmaceutical ingredients.

 

 

 

The GAO also presented a similar report to Congress nearly ten years ago and it would appear during this time nothing much has changed. There has been an accelerating rate of change within the industry over the last 20 years, with massive globalisation of manufacturing occurring driven by the pressure to drive drug manufacturing costs down, and the FDA is becoming more and more overburdened.

 

 

 

At present the FDA only carries out inspections of around 7 per cent of the total number of foreign drug manufacturers a year, and at this rate, the GAO estimated that if the agency was to attempt to inspect the complete list of foreign suppliers even once, it would take over 13 years to do so.

 

 

 

According to the GAO report, China, which has the largest number of drug manufacturers eligible for FDA inspection (714) is earmarked for only 13 regulatory visits by the FDA this year, meaning only less than 2 per cent of the country's drug exporters will have their facilities examined.

 

 

 

However, it is China of all places that should be subject to particular regulatory scrutiny - over the past few years a spate of safety scares over Chinese-made drug substances has been well documented, along with numerous convictions of corruption amongst some of the country's high-ranking regulatory officials.

 

 

 

The FDA's inadequate computer systems are said to be to blame for much of the problem. The GAO found that the agency's databases contain conflicting information on foreign manufacturers, particularly in regard to the number of facilities that are subject to inspection, with the number sometimes differing by thousands, depending on which database is accessed.

 

 

 

"How can we have any confidence FDA is truly managing the risk that may come from foreign-made drug products if the FDA doesn't know the exact number or location of foreign drug manufacturers," Republican Bart Stupak said during the hearing.

 

 

 

The agency is well aware of this problem - in its 2008 budget it specifically requested $247m (€170m) to modernise and implement new IT systems.

 

 

 

Meanwhile, the fossilised computer systems are not the thing holding the agency back. The foreign inspections that are carried out are not up to scratch, the GAO said, particularly referring to the double standards that the agency has for domestic and non-domestic manufacturers.

 

 

 

US drug makers are required to undergo surprise inspections every two years, while foreign manufacturers are not subject to any regular form of scrutiny and are given advance warning before an inspection takes place. Furthermore, the agency has to rely on translators provided by the foreign manufacturers themselves during the process.

 

 

 

During the congressional committee hearing on Thursday, pharma industry representatives branded this double standard as unfair, however, they insisted that they took responsibility for ensuring the quality of imported ingredients into their own hands, rather than relying on the FDA.

 

 

 

The US drug companies participating in the hearing said that they perform periodic inspections of the foreign plants where they source materials from and also perform random tests on the shipped product from time to time.

 

 

 

Despite the revelations of the GAO audit, the head of the FDA Dr Andrew von Eschenbach insisted that the US drug supply is safe.

 

 

 

In his testimony, he said that facility inspections are just one part of the agency's monitoring of foreign-made drugs. FDA approvals of new drugs include requirements regarding how and where a drug is manufactured, he said.

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