Sens. Edward M. Kennedy (D-Mass.) and Charles Grassley (R-Iowa) introduced a bill on April 23, 2009, that provides resources and enforcement tools to strengthen the FDA's grip on medical devices and pharmaceutical products. The proposed Drug and Device Accountability Act of 2009 enhances the FDA's authority to detain medical devices and pharmaceuticals suspected of being adulterated or misbranded, and increases the number of foreign manufacturer and importer inspections. It also allows the FDA to issue subpoenas, tolls additional inspection fees and requires an individual to certify that drug or device applications and safety reports comply with applicable regulations and are not false or misleading. The penalty for drug/device application and safety report misrepresentations includes civil and criminal penalties.
The FDA has long come under fire from individuals within and outside the agency. For example, FDA scientists have raised serious allegations of the agency's mishandling of medical device reviews. In an effort to address this issue, the bill requires the Institutes of Medicine to conduct a study to examine the FDA's process for medical device approvals and clearances.
Speaking on the floor, Sen. Grassley stated that this legislation seeks to address nagging issues within the FDA related to delays in identifying safety problems, a failure of accountability, the quashing of scientific opinion within the agency and the inability to inspect adequately foreign medical device and pharmaceutical facilities. An increasing number of drugs and devices are manufactured overseas. FDA officials estimate that it inspects foreign Class II device manufacturers once every 27 years and foreign Class III device manufacturers once every six years. The number of pharmaceutical facility inspections is likewise poor. In 2007, only 11 inspections were conducted in China, the world's largest producer of active pharmaceutical compounds and the nexus of most contaminated products.