Senators Chuck Grassley (R-IA) and Ted Kennedy (D-MA) have introduced the Drug & Device Accountability Act of 2009 in the hopes of giving the U.S. Food & Drug Administration (FDA) additional resources to inspect both US and foreign drug and device manufacturing plants and more authority to impose penalties.

The Drug & Device Accountability Act of 2009

Although similar to legislation introduced in the last Congressional term but never acted upon, the Drug & Device Accountability Act of 2009 would, according to a press release issued by Grassley, “...augment the FDA's resources through the collection of inspection fees. The bill also would expand the FDA's authority, including new subpoena powers, for ensuring the safety of drugs and medical devices made domestically and in other countries. Finally, the bill would require certification of applications for drugs and devices needing FDA approval and establish civil and criminal penalties for false or misleading certifications.”

FDA responsibilities

Grassley says that, although the FDA is responsible for inspecting pharmaceutical companies, the agency doesn't do nearly enough. He was quoted as saying, “An increasing number of drugs and ingredients for pharmaceuticals are being manufactured in other countries, yet studies show the FDA doesn't know how many foreign plants are subject to inspection, and the FDA conducts relatively few foreign inspections each year.”

He pointed to information obtained by the US Government Accountability Office (GAO) which showed that in 2007, the FDA only conducted 11 inspections in China – a country which supplies the United States with a great deal of active pharmaceutical ingredients such as the blood thinner, Heparin, which was the subject of numerous deaths last year due to contamination. The same report showed that only 14 inspections were conducted in Switzerland, 24 in France and 18 in Germany during that same time frame.

He said that he believes the Drug & Device Accountability Act is a “...practical solution to beefing up the FDA's inspection work, both domestically and abroad, and holding the FDA accountable for its review of medical devices, where questions have been raised about the agency's work."

The bill is currently scheduled to be debated on the Senate floor.