A bill is headed to the president's desk that cancer patients and survivors have reason to celebrate. Last night the Senate overwhelmingly passed the final Prescription Drug User Fee Act (PDUFA). This bill renews an important partnership between the government and drug industry reauthorizing an industry-supported user fee program that provides funding to ensure that the FDA has the resources it needs to conduct expedited reviews of new pharmaceutical drugs and medical devices. The final bipartisan bill was developed by a House-Senate conference committee and passed in the House last week. The law the president is about to sign contains provisions that ACS CAN worked hard to have included on behalf of patients. Collectively, this legislation will help patients access lifesaving medications and devices that treat cancer and its side effects. First, the bill takes steps to mitigate the ongoing drug shortage problem that has affected too many cancer patients. It directs manufacturers to provide the FDA with early notification of a potential discontinuation or interruption in the drug manufacturing process that could lead to a shortage. It also establishes an FDA task force to work with manufacturers and the Secretary of HHS to ensure alternative sources of drug supply are available in case of a shortage. Second, the bill works to enhance patient participation in the FDA's drug and device approval process. (I wrote last month about the Senate's consideration of this provision in their original version of the bill.) Specifically, the FDA must implement strategies that will better identify patients eligible to participate in appropriate agency meetings with medical product sponsors and investigators and provide the patient perspective. Having experienced treatment personally, patients bring a unique perspective on the benefit and risks of new drug therapies. Lastly, thanks in large part to the advocacy efforts of ACS CAN, the final legislation did not include a provision from the Senate version of the bill that would have made it more difficult for cancer patients to obtain medications that help them manage pain. The New York Times did an enlightening piece on this just before it was struck. I'm pleased that the president and Congress see the importance of these provisions for the health and wellbeing of people with serious illnesses. And I'm confident this law will make a significant difference in the lives of cancer patients. *Image retrieved from: http://bit.ly/NO3ShZ
The true costs of cancer are heavy, they are deep, and they are ultimately unaffordable for many, a challenge further exacerbated by this year’s COVID-19 pandemic and spotlighted by the upcoming Supreme Court case challenging the Affordable Care Act.