Bad news. The dangerous anti-regulation campaign sweeping Congress has hit the Food and Drug Administration (FDA) – the agency tasked with ensuring the safety of our drugs and medical devices. Over the last two months, several members of Congress have introduced misguided bills that would make it easier for manufacturers to sell new, unsafe medical devices, and in turn put patients’ lives at risk.
Evidently, some members of Congress are buying into the arguments from the medical device and pharmaceutical industries that the process to approve drugs and devices is too lengthy, blocking their products from the market, and depriving pharma and device companies of their precious profits. However, contrary to industry’s statements, the FDA recently reported that its approvals of new drugs have increased.
The industries’ predictable talking points come as they negotiate with the FDA and Congress over a process to reauthorize fees collected from the industry and reevaluate FDA rules and practices. The process is expected to be completed in 2012. Unfortunately, if these anti-safety initiatives gain traction the lives of patients will take a back seat in the negotiations.
The innovation and continued improvement of drugs and medical devices are important health care goals, but the FDA shouldn’t lose focus on ensuring their safety. Recent history shows that dangerous drugs and devices have unnecessarily injured or killed hundreds of thousands of patients, strongly indicating that industry profits trumped patient safety in numerous instances.
Most of the proposals pending in Congress would only make matters worse for patients. Passage of these bills would undoubtedly lead to more casualties. Recently, Public Citizen sent a letter voicing strong opposition to a U.S. Senate bill intent on loosening medical device regulations.
Instead of heeding the industries’ every demand, Congress and the FDA should make the safety of patients a priority in their negotiations. They should consider ways to improve the FDA processes so that medical devices are safer not more dangerous. Today, the U.S. Senate Committee on Health, Education, Labor and Pensions held a hearing to discuss the regulation of medical devices, and we hope that the best interests of patients is front and center. Over the next several months, Public Citizen will provide important updates as these critical negotiations develop. We will work to ensure that Congress and the FDA consider the need to protect the public’s interest over the need to safeguard the industries’ profits.
Christine Hines is Consumer and Civil Justice Counsel at Public Citizen’s Congress Watch division