The U.S. Department of Health & Human Services (HHS) requested that the FDA
budget for the fiscal year 2009 is raised by an additional 275 Mio US $. In
addition the Congress was asked to approve the request quickly. Overall, this
budget request would mean a total increase of 17% to 407.7 Mio US $.
The budget request can be seen in connection with the current change the FDA is
striving for. The money will be needed to realise the "Action Plan for Import
Safety" (also see the
news from 21 May 2008). The focus is primarily on safety
of imported products:
- Increased presence with FDA offices outside of the USA
- Cooperation with other authorities (e.g. adopting
certificates and inspection reports); this matter still has to be cleared by
the US Congress
- More inspections within the country as well as outside of
In addition, the authority intends to define new requirements
with regard to clinical trials, pediatric medicines and medicinal products.
Altogether this means that the FDA consequently realises its plans. The US
Congress approval is very likely.
On behalf of the European Compliance Academy (ECA)