Senators Chuck Grassley (R-IA) and Ted Kennedy (D-MA) introduced legislation last Thursday that would give the US Food and Drug Administration more resources to inspect domestic and foreign plants that manufacture drugs and medical devices. The Drug and Device Accountability Act of 2009 would increase the agency’s funds by collecting inspection fees. The bill would also increase FDA’s power to ensure drug and medical-device safety by expanding its authority to inspect foreign manufacturers and importers, allowing it to issue subpoenas, and enabling it to detain a device or drug when inspectors have reason to believe a product is adulterated or misbranded.
In a statement on the Senate floor, Grassley said the bill is intended to address weaknesses in FDA’s inspection process. He cited a November 2007 report by the Government Accountability Office stating that FDA does not know how many foreign establishments are subject to inspection. The agency conducts relatively few foreign inspections, Grassley said, and they are “often conducted in countries with few reported quality concerns.”
“In China, the world's largest producer of active pharmaceutical ingredients, and where we have seen increasing reports of contaminated products, only 11 inspections were conducted during FY 2007,” Grassley said in his statement. “During the same year, FDA conducted 14 inspections in Switzerland, 18 in Germany, and 24 in France—all countries with advanced regulatory infrastructures,” he added.
If enacted, the bill would require individuals who submit a drug or device application or a safety or efficacy report to certify that the application or report complies with applicable regulations and is not false or misleading. The bill would impose civil and criminal penalties for false or misleading certifications.
In his statement, Grassley said the certification requirement was important because of recent revelations that “some companies have withheld important safety information from the FDA or buried that information in their submissions to the agency.”
The Drug and Device Accountability Act of 2009 is similar to legislation that Grassley and Kennedy introduced last year but that Congress did not have an opportunity to act on.