Rep. Lance to reintroduce MODDERN Cures Act

On Thursday, Rep. Leonard Lance (R-N.J.) will reintroduce in the U.S. House of Representatives a bill that is intended to stimulate the development of diagnostics and potential therapies that have no patent protection. The Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network (MODDERN) Cures Act was first introduced in 2011 but never made it out of committee. The bill to be introduced on Thursday is largely identical to the 2011 bill but includes some changes that a spokesperson for Lance said were technical in nature or "made to conform" with the FDA Safety and Innovation Act, which was signed into law last year.

The bill would provide 15 years of exclusivity as an incentive to develop "dormant" therapies that could treat unmet medical needs but have been abandoned or ignored by commercial sponsors because of insufficient patent protection. The bill also would create incentives for drug sponsors to develop companion diagnostics by providing six months of data exclusivity for developing a diagnostic for an approved drug, or 12 months if simultaneously developing a companion diagnostic with the drug. ...