On September 12, 2013, Representative Leonard Lance (R-NJ) reintroduced the “Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2013” or the “MODDERN Cures Act of 2013,” H.R. 3091, which creates a new 15-year exclusivity for certain drugs indicated for life-threatening and serious conditions and extends exclusivity for drugs and biologics associated with new innovative diagnostics.1 The Congressman had introduced a similar bill in 2011, but it died in the 2011-2012 Congress.2
I. New Exclusivity
The bill establishes a new exclusivity for a drug or biologic designated as a “dormant therapy,” which requires that the Food and Drug Administration (FDA) determine that the drug or biologic is “being investigated or is intended to be investigated for an indication to address one or more unmet medical needs” and the sponsor has developed a “suitable clinical plan” for this investigation. 3
The bill defines “address one or more unmet medical needs” as either “for the treatment of one or more life-threatening or other serious disease or conditions for which no therapy exists,” or, if one or more therapies are available, certain information is demonstrated through clinical investigations, such as: 4
- An improved effect on serious outcomes of the disease that are affected by alternative therapies, e.g., the medicine is superior in an active controlled trial assessing an endpoint reflecting serious morbidity;
- An effect on serious outcomes of the disease that is not known to be affected by alternative therapies, e.g., progressive disability in multiple sclerosis; or
- An ability to provide a benefit comparable to those of alternative therapies but with improvement in a factor, e.g., compliance or convenience, that is demonstrated to lead to improved effects on serious outcomes.
To obtain the designation, the sponsor must submit a request for designation on or before an application was submitted for a drug or biologic that shares an active moiety that is the same as an active moiety in a drug for which designation is being requested, or that is “highly similar” to an active moiety in a biologic for which designation is being requested.5 According to the bill, sponsors must also waive the right to enforce any patent on its drug or biologic that may expire after the exclusivity expires against products that are approved after the exclusivity ends under a 505(b)(2) application6 or licensed under a section 351(k) of the Public Health Service Act application and relies on the approval or licensure of the product designated as a “dormant therapy.” 7
Once FDA grants the designation, the agency is prohibited from approving for a period of 15 years from when the dormant therapy’s application is approved a 505(b)(2) application, an abbreviated new drug application (ANDA), or an application pursuant to section 351(k) of the Public Health Service Act that relies on the approval or licensure of:
- the product designated as a “dormant therapy;”8 or
- a drug or biologic approved or licensed after the dormant therapy was approved or licensed and which contains the same active moiety as the dormant therapy contains in the case of a drug or contains a “highly similar” active moiety to the dormant therapy’s “active moiety” in the case of a biologic. 9
The agency is also prohibited from approving for 15 years a new drug application filed under 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA) or an application filed pursuant to section 351(a) of the Public Health Service Act that contains the same active moiety as the dormant therapy in the case of a drug, contains an active moiety that is highly similar to the active moiety in the dormant therapy or for a biological product. 10 However, the bill allows these applications to be approved if, among other requirements, information provided to support its approval is “comparable in scope and extent, including with respect to design and extent of preclinical and clinical testing, to the information provided in the approval of the application for the dormant therapy.” 11
According to the bill, dormant therapies that are ultimately approved or licensed would also be entitled to extend patent terms until the end of its exclusivity period if an applicable patent would expire before the end of the period.12 However, dormant therapies would not be entitled to certain other protections if applicable, such as orphan drug exclusivity, and sponsors would need to periodically certify that the dormant therapy was being developed to address one or more unmet medical needs.13
II. Extension of Exclusivity for Diagnostic Tests
To promote the development of innovative diagnostics, the bill also permits FDA to extend various exclusivities already granted for drugs and biologics at the request of a sponsor or manufacturer if the manufacturer or sponsor of the drug or biologic participates in the development of certain diagnostic tests. 14 Exclusivity would be extended by six months, unless the test was developed contemporaneously with the development of the drug or biologic, in which case it would be extended by one year. 15 The exclusivity would be extended in addition to any extension granted for pediatric exclusivity, but extension could not be extended more than twice for the same drug or biologic, or be extended more than once for the same indication to be treated by the same drug or biologic. 16
These diagnostic tests must, as determined by the agency:
- “Provide for or improve the identification of a patient population for which [the sponsor or manufacturer’s drug or biological product] will or will not be used” according to its approved indications; 17
- Provide for or improve the determination of the most appropriate treatment option for a patient population with the sponsor or manufacturer’s drug of biological product according to its approved indications; 18 or
- Provide for the detection of a qualifying pathogen.
Each of the above must be supported by “valid scientific information,” e.g., peer-reviewed literature.
As of the date of this article’s publication, the bill has the support of five democrats and ten republicans. The bill has been referred to the House Committees on Energy and Commerce, Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker. The bill text is available here. 19