The Government Accountability Office issued a report last week that listed the FDA as a “high-risk” area of the federal government. The GAO said the U.S. Food and Drug Administration was being hampered by globalization, more complex products, and laws that have made it more difficult for the FDA to ensure the safety of pharmaceuticals, biologic drugs, and medical devices. GAO says its work examining a variety of issues at FDA echoes the conclusions reached by others (think IOM) that the agency is facing significant challenges that compromise its ability to protect Americans from unsafe and ineffective products. FDA needs to, among other things, improve the data it uses to manage the foreign drug inspection program, conduct more inspections of foreign establishments, systematically prioritize and track promotional materials for review, and adopt management tools to ensure that drug sponsors comply with regulations on the presentation of clinical trial results.
The perception of the FDA and its ability to do an effective job is a crucial underlying feature in product liability litigation involving regulated drugs, devices, and food products. Jurors’ perceptions of the agency can affect a myriad of issues and themes the defense may wish to present.
Meanwhile, the Pharmaceutical Research and Manufacturers of America (PhRMA) asserts that the issue is a need for more resources for the FDA, to keep drugs safe. The agency “is being asked to do more than it can do” with current resources, the trade group says. Specifically, FDA needs more resources to conduct foreign inspections so the drug supply can be kept safe. PhRMA also said that FDA needs more resources to modernize because, for example, the agency still looks at clinical trial information on paper.