US FDA Lax on Foreign Drug Firm Inspections
The US Food and Drug Administration is incapable of guaranteeing that America’s pharmaceutical supply is safe, because only a small percentage of overseas drug firms come under its scrutiny. Even when done, these inspections are not carried out to the same standard as when undertaken in the US.
This was the damning report given by witnesses to a Congressional subcommittee on the 1st November 2007.
Although companies based overseas provide up to 80 per cent of the ingredients that appear in US-made drugs, the FDA’s records lack the detail to say, definitively, which of these firms have come under inspection, and which have slipped through the net. So said the report heard by the House Energy and Commerce Subcommittee on Oversight and Investigations.
The report was compiled by the Government Accountability Office. The body’s Director of Health Care, Marcia Crosse, compared the US FDA of the late 1990s to that of today, stating: “More than nine years after we issued our last report on this topic, FDA’s effectiveness in managing the foreign drug inspection program continues to be hindered by weaknesses in its data systems.”
The witnesses that testified to the subcommittee included Carl Nielson – the former director of the strand of the US FDA that deals with imported products – as well as Ms Crosse. Mr Nielson highlighted how, since a similar report on the US FDA undertaken at the end of the 1990s, no real progress could be noted. "The system was broken then and it is broken now”, he stressed.
FDA Needs to Focus More on Chinese/Indian Drug Production
Mr Neilson additionally identified a need for the the US FDA to adapt to global shifts in the pharmaceutical industry, including additional focus on India and China.
In 2007, 3,249 overseas drug firms were identified by the US FDA as those that should come under its inspection. According to the Government Accountability Office, however, the agency is only able to say with certainty that 1116 such inspections have been carried out to date.
As confirmed by data released in advance, the regulator proposes to inspect a mere 300 overseas drug firms in 2007. By way of contrast, a large percentage of its planned US inspections have been made.
The FDA’s overseas inspection list includes 714 China-based drug companies. As per the report, only 13 of these will be assessed by the regulator this year.
Source – Pharmaceutical International’s US Correspondent
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