Washington, D.C. – Congressman Michael C. Burgess, M.D. (R-TX), chairman of the House Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade, on Tuesday introduced bipartisan legislation that would allow manufacturers of “Research Use Only” products without over-burdensome regulation from the Food and Drug Administration. The bill was co-authored by Congresswoman Jackie Speier (D-CA). 

The Medical Testing Availability Act, H.R. 298, would prohibit the implementation of previously proposed regulatory changes to medical testing products the FDA designated for “Research Use Only.” The bill would enshrine in law correct practice allowing communications among customer service and technical support entities between the drug or testing product’s manufacturer and the user of the product on “Research Use Only” materials.

“Incredible advances in personalized medicine hold great potential for patients and healthcare providers to detect, diagnose and treat disease,” Burgess said. “But physicians and medical professionals must be able to access them in order to provide the best care for their patients. Our bill is an important step towards improving medical innovation in the United States and, ultimately, finding cures to ailments that affect thousands of Americans each year.” 

“This narrowly tailored bill strikes a clear balance between the important developments in personalized medicine and the rights of patients to safely explore new care options,” Speier said. “The potential for personalized medical care is limitless. With new technologies developed in many companies in my district, we are experiencing an information revolution in patient diagnostics. Every patient is an individual. By supporting this growing industry, we can ensure doctors of the future have access to the best information possible to treat their patients. I am proud to work with my colleague Congressman Burgess on this bipartisan effort.”

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