New draft Bill to boost combination products for serious diseases
H.R. 6502, "The Life-Threatening Diseases Compassion through Combination Therapy Act of 2012," was proposed to the House Committee of Energy and Commerce by representative Bilbray on September 20. This bill, which is also supported by the Melanoma Research Foundation, would provide an extension of market exclusivity if the treatment contains 2 or more new drugs or biologics that in combination, treat a life-threatening disease. This is also complementary to the 2010 FDA Guidance, "Codevelopment of Two 3 or More Unmarketed Investigational Drugs 4 for Use in Combination" in order to encourage the co-development of drugs and/or biologics for serious diseases. The bill would extend the original exclusivity level (3, 4, 5, or 7 years) by 6 months.
To read the full bill: http://www.hpm.com/pdf/blog/HR_6502_Combination_Therapy.pdf