The Association of Contract Research Organizations (ACRO) wants more funding for the FDA to allow it to be much more active in the oversight of foreign clinical trials. ACRO would like to see the FDA budget to fund these inspections be increased to $35 M (seems small to me to regulate multi-billion industry).
ACRO's vice president of public affairs, John Lewis said, “We think this should come from increased appropriations for FDA, even in the current difficult budget environment.” This would require a big increase on the $17m (seems very inadequate to me) currently allocated for the FDA’s the Office of International Programs (OIP) in fiscal 2011.
Lewis indicated that ACRO would also like to see the FDA and EMA become increasingly active in sharing their expertise with regulatory agencies aroudn the world. He noted that drug development is now a "global enterprise."
Posted by Bruce Lehr October 30th 2010.