Representative Leonard Lance (R-NJ) recently introduced a bill that includes proposals for enhancing the reimbursement system for diagnostic tests, as well as incentives for pharmaceutical firms to revive unapproved drugs in their pipelines as treatments for unmet medical need.
For many diseases, especially degenerative conditions, autoimmune diseases, and cancer, "the patent for the drug compound sometimes expires before or soon after the product is brought to market," the National Health Council and Lance's legislative office said in a statement this week. "Thousands of these potential treatments are just 'put on the shelf,' and thus, lie dormant.”
The Modernizing Our Nation's Drug and Diagnostic Evaluation and Regulatory Network Act, or MODDERN, “would grant a regulatory process to encourage the commercial development of these dormant therapies,” they added.
MODDERN has been under development for five years, according to the National Health Council, a patient advocacy organization that has been organizing support from patient groups for the bill.
As previously reported by PGx Reporter, the drafters of the bill believe that MODDERN, if passed, will spur the development of personalized therapies.
For example, the bill would reward drug companies developing drug/diagnostic combination products by extending the period during which competitors would be barred from gaining marketing approval for drugs with similar compositions. At the same time, the bill would also enhance the process by which payment levels are set for diagnostics and create a system for issuing temporary reimbursement codes for new tests, facilitating faster payment (PGx Reporter 9/21/2011).
"More than 133 million Americans — over 40 percent of the people in this country — have at least one chronic disease or disability. Despite the roughly $80 billion spent annually on medical research and development, many conditions lack effective treatments,” said Myrl Weinber, National Health Council president. MODDERN “will advance personalized medicine by getting the right medicines to the right people. It will ensure that science, not patent law, drives the development of new therapies," she said.
The bill, which currently doesn't have a co-sponsor, was introduced on Nov. 18, and has been referred to the House Committee on Energy and Commerce, the Committees on Ways and Means, and the Judiciary Committee.
According to statistics cited by the National Health Council, on average a drug works only in 50 percent to 75 percent of the people who take it. With this bill, Lance said he is trying to spur the development of drugs and tests that patients need but that industry currently doesn't pursue due to the lack of incentives.
“The status quo is not yielding treatments needed to address the growing epidemic of chronic disease. That is why it is vital that we update the regulatory system by removing the barriers to invention and providing greater predictability in the search for therapies for unmet medical needs,” Lance said in a statement.