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 the US

In addition, the authority intends to define new requirements with regard to clinical trials, pediatric medicines and medicinal products.

Source: http://www.hhs.gov/news/press/2008pres/06/20080609a.html

Altogether this means that the FDA consequently realises its plans. The US Congress approval is very likely.

Author
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)