Proposed Legislation May Empower FDA, Help Patients
March 15, 2012
It’s tough to imagine a more appropriate name for the latest bill moving through Congress that could speed up the delivery of new drugs and new therapies for mesothelioma patients.
It’s called the FAST Act, which stands for Faster Access to Specialized Treatments, which was introduced earlier this month by Representative Cliff Stearns (R-Florida). He was assisted by Ed Towns (D-New York).
The FAST Act hopes to build on the drug development incentives put in place years ago by Congress. The Act is an attempt to expand the authority of the United States Food and Drug Administration, allowing it to expedite the access to novel treatments for patients with serious and life-threatening diseases.
Mesothelioma is a rare cancer caused by an exposure to asbestos. There is no known cure.
It is aggressive with a poor prognosis. It normally escapes diagnosis until it already has spread extensively. It attacks the lining around the chest wall and the lungs. Although there have been advances in the treatment of mesothelioma, the steps have been small in the past two decades.
The FDA originally created an Accelerated Approval process in 1992 to make new drugs available, and there have been numerous attempts through the years to speed up the process.
“However, the modern FDA’s approval rate for drugs and medical devices has slowed immensely,” Stearns said. “This measure codifies much of the Accelerated Approval regulations into statue and modernizes the program to reflect the amount of medical and scientific innovations that have occurred in the past 20 years.”
The bill follows the Transforming the Regulatory Environment to Accelerate Access to Treatment Act, which was introduced in the Senate last month with similar intentions for therapies used to treat illnesses with the “Orphan Disease,” designation.
In January, Congressman Leonard Lance was promoting the MODDERN Cures Act, which summarized his mission to “modernize our drug and diagnostics evaluation and regulatory network.” His bill also was intended to accelerate the process of bringing new drugs from the research labs to the market.
“. . . FDA should be encouraged to implement more broadly effective processes for the expedited development and review of innovative new medicines intended to address unmet medical needs . . . using a broad range of surrogate or clinical endpoints and modern scientific tools earlier in the drug development cycle,” according to FAST Act bill proposed this month by Stearns.
A broader oversight in drug development for the FDA has brought praise from pharmaceutical companies and outside organizations, who understand the economics and human factors in speeding up the process.
Up to 3,000 people in the United States are diagnosed each year with mesothelioma.
“Because the diseases are rare, there is a disparity in access to drugs and treatments,” Stearns said. “Under normal market conditions, there is no incentive for the pharmaceutical industry to develop and market drugs for patients suffering from rare and ultra-rare diseases. This . . . will help the rare disease community.”