The MODDERN Cures Act
More than 133 million people in the United States live with a chronic disease or disability. For many, there are no existing treatments for their condition; medicines that could help improve their quality of life simply do not exist. We may never be able to cure or treat every disease, but we should ensure that the U.S. is doing all it can to encourage the development of new, safe and effective medicines to help as many people as possible.
Public policy decisions can greatly impact how fast and how many new, safe and effective medicines reach patients. There are aspects of the U.S. regulatory system that allow new drugs to reach patients in need. For example, the Prescription Drug User Fee Act (PDUFA) has helped create one of America's most productive and innovative periods of new drug development. Since PDUFA was passed into law in 1992, more than 1,000 new drugs have been approved by the Food and Drug Administration (FDA), including 39 new drugs in 2012 - a sixteen year high.
However, when it comes to treating rare diseases and conditions for which they are few or no existing medicines, improvements can be made. This year, there is an opportunity to change that: the Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network (MODDERN) Cures Act, which would dramatically transform the drug development and approval process and allow new, safe drugs that treat or cure unmet medical needs to come to market faster. This kind of policy is necessary because creating drugs to treat or cure unmet medical needs-such as autoimmune diseases, neurological conditions, cancer, and rare diseases-present additional challenges and take longer than average to develop.
The Challenges of Pharmaceutical Innovation
Developing a new medicine is a complicated, time-consuming, and expensive process. On average, only one out of every 10,000 new compounds developed is approved by the FDA, and the costs associated with transforming a new drug from a molecule into a medicine average more than $1 billion. In order to continue this cycle of research and discovery, drug manufacturers need the opportunity to recoup the investments they have made in the development of potential new medicines (including those compounds that never make it to market.)
Two important factors give companies the opportunity to recover their drug development cost: patents and data protection. Currently, companies begin the process of seeking patent protection for a new molecular compound early in the development period with an application for a patent through the U.S. Patent and Trademark Office (PTO). If a patent is granted, which is not an easy process, a compound is given 20 years of patent protection. However, the molecule must then go through a lengthy development process, be tested in multiple clinical trials, and be submitted for review by the FDA. If a drug is approved by the FDA, much of that drug's patent protection has already expired, generally leaving less than 10 years of patent protection once a new drug has reached market. A new drug may also be granted data protection for a period of 5 to 7 years, depending on several factors such as the type of drug.
Given the complexity in developing new medicines for unmet medical needs, the high failure rate, and the ongoing patent litigation, the costs can often outweigh the rewards for bringing such drugs to market. The MODDERN Cures Act could fix this dilemma.
The MODDERN Cures Act
In 2011, Representative Leonard Lance (R-NJ) and Representative Jay Inslee (D-WA) introduced the MODDERN Cures Act of 2011, a bipartisan bill that encouraged the development of new, targeted treatments and cures by modernizing the country's regulatory system. Specifically, the MODDERN Cures Act would promote the development of personalized medicine, and incentivize investment in the most challenging therapeutic areas by:
Establishing a "dormant therapies" class for medicines that treat complex conditions with few or no existing treatments. These therapies would be given additional years of shared patent and data protection to further incentivize the pharmaceutical and biotechnological industry to develop and bring these new drugs to market.
Advancing research into personalized medicine by encouraging the development of companion diagnostics tests. As a result, doctors could more easily identify the most appropriate and effective treatment for each individual patient.
Granting patients greater, timelier access to new FDA-approved diagnostic tests.
With its focus on addressing unmet health needs, rejuvenating the drug and diagnostic development incentive system, and ensuring more timely access to treatments, the MODDERN Cures Act could be a life-changer for millions of patients and their families.
The MODDERN Cures Act is expected to be reintroduced in the House this year and we will continue to work with our allies to support its passage, which would be one step towards bringing new, life-saving medicines to patients in need.
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