John Lewis, vice president of public affairs at the US Association of Clinical Research Organisations (ACRO), told Outsourcing-Pharma his group “would like to see much more emphasis on oversight of clinical trials.
“We think this should come from increased appropriations for FDA, even in the current difficult budget environment,” Lewis continued, which would require a big increase on the $17m currently allocated for the FDA’s the Office of International Programs (OIP) in fiscal 2011.
He also advocated greater co-operation between agencies worldwide on the basis that “Drug development is a global enterprise so it is critical that established regulators like the FDA and EMA share expertise and information with regulators in developing countries.”
This type of collaboration, Lewis suggested, would also require additional funding for the FDA’s overseas units as such “in country” presence is critical to fostering relationships between regulators.
However, even if the ACRO’s call for additional funding is met, the scale of the trials sector will still represent a challenge as, according to a recent Department of Health and Human Services’ (HHS) Office of Inspector General report, the FDA only reviews a small fraction of trials conducted outside of the US.
The research revealed that, although 80 per cent of marketing applications for drugs approved in the US contain data from trials carried out overseas, in 2008 the FDA only inspected 0.7 per cent of the trials conducted outside the US, compared with 1.9 per cent in the country.
ACRO’s call for more overseas trial inspections follows just days after the publication of a new US Government Accountability Office (GAO) report called for additional support for the FDA’s international offices to ensure the quality of drug manufacturing.
The GAO stated that although the FDA has taken measures to help ensure the safety of imported products, the increasing number of products on the US market made outside the country presents a number of challenges which could limit the agency’s effectiveness in drug policing.