FAST Act legislation could assist those with rare diseases

A new bill recently introduced to Congress could assist in a speedier delivery of new drugs and therapies to patients with rare diseases and cancers such as mesothelioma. The FAST Act, which stands for Faster Access to Specialized Treatments, was recently launched by Representative Cliff Stearns (R-Florida). The bill is co-sponsored by Rep. Ed Towns (D-New York). Among his various political responsibilities Rep. Stearns is a senior member of the House Energy and Commerce Committee. According to Congressman Stearns’ website, the FAST Act “codifies much of the [FDA’s] accelerated approval regulations into statute and modernizes the program to reflect the amount of medical and scientific innovation that has occurred in the past 20 years.” Congressman Stearns believes the FAST Act will greatly impact the rare disease community. According to the FDA, in order for a condition to be labeled rare in the United States it must be a condition that affects fewer than 200,000 people. The FDA estimates that approximately 30 million Americans are afflicted with rare diseases. Mesothelioma is a cancer that affects the lining of the lungs primarily, and in some cases the lining of the heart or abdomen. New cases of mesothelioma are estimated to occur within 2,000 to 3,000 Americans annually, qualifying it as a rare form of cancer; there is currently no known cure. Stearns states that due to their rare occurrence “there is a disparity in access to drugs and treatments;” additionally, normal market conditions provide no incentive “for the pharmaceutical industry to develop and market drugs for patients suffering from rare and ultra-rare diseases.” These factors and industry conditions are why drugs of this nature are known as “orphan” drugs. The FAST Act is not the first of this type of legislation brought forward by Reps. Stearns and Towns. In 2011, the two congressmen introduced the Unlocking Lifesaving Treatments for Rare Diseases Acts, or ULTRA. Ultra was intended “to promote the discovery and development of safe and effective drugs and treatments to prevent, diagnose, or treat rare and ultra-rare diseases.” Legislation such as those mentioned in this article offers promise to patients afflicted with rare diseases and cancers, offering them hope towards a cure and improved treatment options. Patients with mesothelioma are typically left with the option of undergoing aggressive surgical, radiation, and chemotherapies. Those diagnosed in the advanced stages or otherwise unable to undergo aggressive procedures generally receive palliative treatments focused on relieving symptoms, rather than eliminating malignancies. The FAST Act could help create a segue between state-of-the-art therapies and treatments and the patients that need them. Reference: Previous: 29-Year Old Virginia Firefighter Diagnosed with Mesothelioma Next: Quebec to Fund Reopening of Asbestos Mine