The FDA plans to increase field tests in imported drugs by over 100 per cent and has requested a 19 per cent rise in its budget for 2010 to enable it to achieve this and other targets.
Revamping the US Food and Drug Administration’s (FDA) food safety initiatives programme accounts for some of the $3.2bn (€2.35bn) budget, with the recent salmonella scare raising the area’s profile, but securing the drug supply chain is also prominent in the plans.
These efforts include an increase in the number of field tests of imported drugs from an estimated 2870 this year to a target of 6197 in 2010. This will be accompanied by a boost in the inspections of high-risk foreign and domestic facilities, with 700 planned for 2010, up by 100 on the previous year.
However, the overall number of unique FDA inspections of domestic and overseas facilities is scheduled to remain the same in 2010 as 2009 but the agency believes innovative activities will allow it to secure the supply chain.
The budget document states: “In the complex and rapidly changing environment driven by globalisation, FDA cannot rely on traditional approaches – inspection and sampling at the US border – to protect Americans and ensure the safety of medical products.
“FDA will use traditional and innovative mechanisms that include FDA inspections and field exams, integrated federal-state oversight, and greater access to inspection data and results acquired from trusted foreign regulatory authorities.”
User fees boost budget
The estimated budget authority for 2010 represents a 53 per cent increase on the total for 2006 but user fees have enabled the agency to further boost its spending power over this period.
Over the same period user fees have risen by 113 per cent and in the 2010 estimates account for almost 50 per cent of the human drug sector’s total funding. In particular the 2010 budget proposal is boosted by $36m in generic drug user fees and $10.5m in reinspection fees.
Generic drug user fees are deemed necessary by the FDA to help it cope with the sector’s “dramatic growth” and the “additional burdens” this has placed on the agency.
The FDA added: “Not only will generic drug applications continue to grow, but companies will also be under increasing pressure to cut costs in response to competition. Yet, cost-cutting measures have the potential to compromise drug quality.
“It is imperative that FDA have the resources to ensure the safety, quality, and comparability of generic drugs and allow Americans to benefit from the savings from lower cost generic drugs.”
Further user fees will be generated by the reinspection proposal, which would make companies pay for costs associated with follow up work after a facility failed to meet good manufacturing practices (GMPs).