Safety of foreign-made drugs gets bipartisan support at Senate hearing, but bottom line looms large
At a hearing yesterday, Senate HELP leadership said they would likely include supply chain safety measures in the major drug user fee re-authorization next year (PDUFA V), and showed bipartisan interest in how FDA is dealing with the challenges posed by an outsourced drug supply. This is great news given the increasing risks this unevenly monitored supply poses for patients.
Ranking member Senator Mike Enzi asked FDA Commissioner Hamburg what sort of progress the agency was making on the GAO’s recommendations to increase foreign inspections. Hamburg said it continues to be a priority—she has been vocal about closing the regulatory and capacity gaps that allow foreign drug plants to go nine years between inspections.
Of course, Congressional appropriations are a huge piece of FDA’s ability to improve those numbers. And the recent House-passed budget, which lops 12 percent off FDA’s current budget and 21 percent off its 2012 request—not to mention the looming specter of default–would significantly cut into the agency’s efforts to meet its newly global monitoring demands.
FDA Office of Regulatory Affairs’ Dara Corrigan said earlier this week that such cuts would hobble the agency’s foreign inspection efforts, as well as its plans to acquire technology that would make inspections more modern and efficient. The agency has been making strides on foreign inspections, doing 27 percent more between 2007-2009. But that progress now hangs in the balance.
According to Inside Health Policy, Corrigan told the Alliance for a Stronger FDA that FDA might be forced to conduct 2,000 fewer domestic inspections and 9,000 fewer import audits under the House-passed FDA appropriations bill.
“We’ll have to do fewer inspections and we’ll have less flexibility to do surveillance,” she said.
–Kate Petersen, PostScript blogger