Biomedica Partners Proposes The Terminal Disease Act
(3 months ago)
CARLSBAD, Calif: Terminal diseases such as cancer, Alzheimer's and cardiovascular disease claim two million lives each year and account for a major portion of our healthcare budget. We have failed at cures and a new approach is required. Biomedica Partners, a healthcare policy reform corporation, is proposing The Terminal Disease Act (TDA) to remedy this.
The TDA would grant a 12-year period of commercial exclusivity for any approved terminal disease treatment regardless of patents. Most of medical science exists in the public domain, is not patentable, and therefore ignored by the drug industry. This grant of exclusivity would open the entire body of medical science to commercialization and greatly increase the flow of new treatment options.
The TDA would also mandate new regulatory approval criteria for terminal disease treatments which would remove the requirement for Phase III clinical trials, the single most costly and time-consuming component of the drug development process. Under the TDA, only a single phase I safety trial and one positive phase II efficacy trial of at least 100 patients would be required for approval. This provision will dramatically reduce both the cost and time required for terminal disease drug development.
These reforms will have an explosive effect the entire pharmaceutical and biotech industry. Start-up Venture Capital funded companies will now be able to complete the drug development process rather be forced to partner with larger companies to fund Phase III trials. Large companies will shift focus to terminal diseases rather than me-too drugs for treatable diseases.
"The TDA is the transformational change required to finally cure terminal disease. It goes far beyond the "Right to Try" initiative currently before Congress which is silent on reforms to speed new approved treatment options for terminal patients," stated Paul J. Marangos, founder and CEO of Biomedica Partners.
The Orphan Drug Act of 1983 had a dramatic effect on treating rare diseases and it only provided 7 years exclusivity for rare disease drugs and was silent on removing excess regulatory requirements for drug approval. The TDA goes further and will have a much greater positive impact on terminal disease patients.
Biomedica Partners is dedicated to accelerating terminal disease cures thru reforming the healthcare system as described in the book; "A Roadmap for Curing Cancer, Alzheimer's and Cardiovascular Disease," by Paul J. Marangos. Published by Elsevier Press.