If there was ever a time to recognize the necessity of expanding access to meaningful health coverage, it’s now.
Senate Considering Legislation to Strengthen Patient Voice in Drug Approval Process
I want to share with you some important information about a bipartisan bill advancing in the U.S. Senate that ACS CAN has been closely monitoring the Prescription Drug User Fee Act (PDUFA). This is a critical bill for cancer patients and their loved ones. For those who are unfamiliar, user fees are funds the industry pays to ensure that the FDA has the resources to conduct expedited reviews of new pharmaceutical drugs and medical devices. With reauthorization, Congress is looking to expand and enhance this program, which will mean cancer patients can get cutting-edge drugs and treatments as quickly as possible. The bill also addresses two issues that are of particular importance to cancer patients. First, the bill would take critical steps to mitigate the ongoing drug shortage problem in our country, which has left cancer patients and survivors without access to lifesaving medicines. The legislation directs drug makers to notify the FDA early of a discontinuation or interruption in the manufacturing process that could lead to a shortage. It also establishes an FDA task force to work with manufacturers and HHS to ensure the availability of alternative sources of supply for drugs in shortage. We hope these measures will help to address this critical problem. Additionally, we learned last week that the U.S. Senate is considering a provision that would significantly strengthen participation by patients in the FDA's drug and device approval process something ACS CAN has been hard at work to make happen. To date, patients have had limited involvement in the FDA's approval process. But having experienced treatment personally, patients bring a unique perspective on the benefits and risks of new drug therapies. If enacted, the legislation would considerably increase the patient voice during the product approval process. Specifically, it would allow the FDA to provide more training for participating patients and require the HHS Secretary to implement strategies to allow FDA staff to better identify eligible patients to participate in appropriate agency meetings with medical product sponsors and investigators. Cancer advocates everywhere commend lawmakers for their bipartisan efforts to pass this critical piece of legislation. If passed, this bill has the potential to make a significant difference in the lives of cancer patients, providing them with timely access to cutting edge therapies, helping to resolve the drug shortage crisis and ensuring that the patient voice is heard as new drugs and devices are considered for approval. *Image retrieved from: http://bit.ly/MAD4SU