By Sandra C. Raymond, president and CEO, Lupus Foundation of America
Ten years ago, most Americans had never heard of lupus – a chronic autoimmune disease. Today, through education and outreach, more people are becoming familiar with the serious impact lupus has on the health of an estimated 1.5 million Americans. With Congress actively considering reauthorization of the Prescription Drug User Fee Act (PDUFA), it has never been more important to focus on the future development of lupus drugs and what is needed to help people with lupus overcome their life-diminishing and life-threatening disease.
Consider the following: it is doubtful that more than 1,000 new critical treatments would have moved through the Food and Drug Administration (FDA) drug approval process in the last 20 years had PDUFA not been in place. Since its 1992 passage, PDUFA-provided user fees have helped the FDA fulfill its core function of ensuring safe and effective drugs are available to improve the health and well-being of Americans. PDUFA offers hope for new treatment for people who suffer from underserved and chronic diseases such as lupus by helping expedite the drug approval process, resulting in new drugs getting to patients in a more timely and efficient manner.