Congress promised a move to beef up FDA oversight of foreign drug plants would come. Four House members have introduced a first draft of legislation that would give regulators new powers--and new manpower--to increase inspections and police substandard products. The sponsors describe it as a starting point, designed for input from FDA "and all stakeholders," which we assume includes the pharma industry.
Reps. Henry Waxman, Frank Pallone, John Dingell and Bart Stupak sponsored the bill, which would require the FDA to boost its foreign oversight to be on par with domestic plants. That's quite a task, considering that the number of overseas manufacturing facilities has skyrocketed in recent years; the FDA has been struggling to inspect them even a fraction as often as U.S. plants. Furthermore, regulating foreign plants requires assistance from local governments that aren't always forthcoming or cooperative.
Details are sketchy, given the proposal's billing as a work in progress. "We know we need to address this," Dingell says in a statement. "The only question now is how." All the bill's current sponsors are Democrats. And, as Reuters points out, if Republicans take control of the House, all bets could be off.
- get the statement from the bill's sponsors
- read the Reuters story
ALSO: At least one Big Pharma is backing a better-funded FDA: AstraZeneca (NYSE:AZN) urged the Obama administration to boost FDA's fiscal year 2012 budget by 20 percent to help the agency effectively manage a growing list of complex public health responsibilities. AZ release