With more drugs and ingredients coming from outside the U.S., the FDA has been taking a harder look and a tougher stance on how foreign manufacturers are standing up to its standards. The FDA made that a focus of its request for more funds in a year in which shrinkage is on the mind of Congress.
In its budget "justification" document, the agency said inspections of foreign manufacturers jumped 10% last year to 813 inspections in 62 countries. And it relied more heavily on inspectors now based outside the U.S. The agency said nearly half of the 46 warning letters issued to foreign manufacturers resulted from inspections by its global staff.
In his budget request, President Barack Obama is asking Congress to approve an $821 million bump in the FDA budget, but nearly 95% of that would come from increases in user fees, according to the Alliance for a Stronger FDA.
Included in Obama's request is $10 million to add 19 inspectors and to increase drug and food inspections in China, now the largest supplier of APIs in the world and a country with lax oversight. An FDA spokeswoman told in-Pharmatechnologist.com that the $10 million was on top of $10 million sought in this fiscal year. Nearly half of that, $4.7 million, would be to add 9 people to the drug inspection cadre. That would allow the agency to do more inspections and also boost its efforts to train China's regulators about U.S. standards, the document says.
"These are tight budget times, and the FDA budget request reflects this reality," FDA Commissioner Margaret A. Hamburg said in a statement. "Our budget increases are targeted to strategic areas that will benefit patients and consumers and overall strengthen our economy."