January 14, 2015

WASHINGTON, DC – Congresswoman Jackie Speier (D-San Francisco/San Mateo Counties) yesterday joined Congressman Michael Burgess (R-TX-26) to reintroduce the Medical Testing Availability Act. This bill, H.R. 298, would ensure patient access to important research tools by preventing the US Food and Drug Administration (FDA) from implementing vague guidelines that would make diagnostic manufacturers liable for misuse of diagnostics intended for research purposes only.

“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,” said Speier. “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.”

“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.”

Previous FDA Draft Guidance indicated that manufacturers of certain diagnostics components should take action if they have “reason to know” that their “research use only” diagnostics are being used for any clinical purpose.  

“Reason to know” is a vague new standard that includes everyday business practices, such as providing technical support to customers. By creating a safe harbor, this bill would affirm that certain “business communications” as these are allowed without touching long-standing regulations designed to ensure patient safety.