Bradley Merrill Thompson Quoted in Article, “Bill Proposes Modernizing IVD Regulations”

IVD Technology

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Bill Proposes Modernizing IVD Regulations," written by Richard Park.

Following is an excerpt:

Congressman Leonard Lance (R-NJ) introduced legislation to promote the development of meaningful treatments for patients with chronic or rare diseases. The "Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network (MODDERN) Cures Act" (HR 3497) would modernize the U.S. drug and diagnostics evaluation and regulatory network by encouraging the discovery and development of new treatments for the many diseases that have few or no options. It would also create a system that rewards efficiency and effectiveness to the benefit of all people with chronic diseases?...

At the same time, some analysts believe the legislation could benefit the IVD industry. "The way the bill leverages existing incentives for drug development to encourage the development of companion diagnostics could provide significant benefits to the IVD industry," said Bradley M. Thompson.

"Under the bill, in exchange for developing a companion diagnostic with a new drug, a pharmaceutical company would be rewarded with six to 12 additional months of market exclusivity and patent protections for that drug," said Thompson.

"Depending on the drug, an extra six to 12 months could mean a lot of money, which is a clear incentive to get companion diagnostics out there. This could lead to more partnerships between the pharmaceutical and IVD industries, and creating new markets for IVDs that can predict responses to new drug therapies," he said.

Thompson added that the bill's proposed reforms for reimbursement of novel diagnostics should also benefit the IVD industry.