MODDERN Cures Act of 2011
112th Congress (2011-2012)- H.R.3497.IH
The MODDERN (Modernizing Our [...] and Diagnostics Evaluation and Regulatory Network) Cures Act was introduced in the U.S. House of Representatives on November 18, 2011. The bill was introduced during the second session of the 112th Congress by Representative Leonard Lance of the seventh district of New Jersey. Representative Jay Inslee is the lead Democratic cosponsor.
This legislation is intended to promote the development of meaningful treatments for people living with chronic disease and disabilities.
Background
A Modern Regulatory System
This legislation is intended to affect all people with chronic diseases. A truly modern regulatory system would benefit patients with a range of conditions and people diagnosed with more than one chronic disease by encouraging the development of new, more targeted treatments. It is also critical to ensure that the limited research dollars available are spent in the most effective manner to meet the needs of patients. The legislation will transform the development process for drugs that slow or stop disease progression for degenerative conditions, such as Alzheimer’s and ALS (Lou Gehrig’s Disease), and for autoimmune diseases, such as lupus, and for cancer.
Key Issues
Dormant Therapies
This legislation would create a new class of drugs named dormant therapies. The term dormant therapy refers to a new [...] or a new biological product that was made the subject of a request for designation in compliance with the legislation, the MODDERN Cures Act. The assignment of dormant therapy is giving to a [...] or new biological product that has been determined to have insufficient patent protection and meets an unmet medical need, improves outcomes, or reduces risk compared to an existing treatment.
In its request for designation of a Dormant Therapy, the manufacturer must provide a list of all patents and applications for patents to which the manufacturer has rights, and must agree to waive those rights in order to receive the designation. This legislation would provide data exclusivity to encourage manufacturers to investigate a dormant therapy to determine if it can prevent, slow the progression of, or cure diseases. The Secretary of Health and Human Services is required to make its determinations available to the public and may not approve a generic for a [...] or biosimilar for a biological product that has the same active ingredient as a [...] that has been designated a dormant therapy.
Sponsors that receive protection under this section of the MODDERN Cures Act would be ineligible for other incentives.
Diagnostic Tests
This legislation would require the establishment of consistent definitions allowing both diagnostic manufacturers and regulatory authorities to work from a common lexicon for diagnostic tests. This legislation puts forth the factors that should be considered in setting payment for a new diagnostic test. In addition, it requires the Secretary of Health and Human Services to seek the advice of an independent advisory panel of individuals with expertise in diagnostic tests. This legislation also requires the Secretary to assign a temporary Healthcare Common Procedure Coding System (HCPCS) reimbursement code to a new test after approval from the FDA.
This legislation would create incentives through data exclusivity to encourage the development of diagnostic tests that help predict the appropriate patient population and determine the most appropriate treatment options.
Guidance Documents
This legislation would require the Food and [...] Administration (FDA) to clarify certain aspects of the approval pathway in order to establish consistency and predictability in the process.
External links
• Food and [...] Administration (FDA)
• Department of Health and Human Services (HHS)
• Centers for Medicare & Medicare(CMS), Healthcare Common Procedure Coding System
• BioCentury discussing the MODDERN Cures Act— BioCentury
• Benefits Communication, Personalized Medicine and MODDERN Cures
• Draft Bill Seeks Personalized Rx Incentives via Exclusivity Extension, Improved Reimbursement