Swalwell and Sessions Lead Bipartisan Effort to Improve Access to Cancer Clinical Trials
WASHINGTON, DC – Rep. Eric Swalwell (D-CA-15) and Rep. Pete Sessions (R-TX-32) led a bipartisan effort to urge the Food and Drug Administration (FDA) to help improve access to clinical trials for cancer treatments.
“The ability or inability to pay travel costs shouldn’t determine who gets to take part in potentially life-saving cancer clinical trials,” said Swalwell. “There’s no reason why a cancer patient’s hopes should be dashed by an empty wallet.”
President Obama in January announced a new National Cancer Moonshot Initiative to accelerate cancer research by enhancing cancer prevention, early detection, and access to treatments. One roadblock in cancer research is that participation in oncology clinical trials remains low, especially among minorities and the economically disadvantaged.
Costs such as airfare, travel, lodging, and gas associated with clinical trial participation contribute to these reduced enrollment rates. Yet many clinical sites and sponsors of clinical trials are wary of providing financial support to cover these costs given current FDA guidance against anticipated financial benefits that may create “coercion or undue influence.”
Swalwell and Sessions led 15 other House Members in writing to FDA Commissioner Dr. Robert M. Califf to express their belief that reimbursement for ancillary costs of participating in a cancer clinical trial actually fits with the principle of distributive justice — combating inequity by offering a chance to those for whom the costs present an undue burden.
They asked the FDA to issue more precise guidance to let appropriate stakeholders provide the financial support necessary to level the playing field for patients who wish to enroll in a cancer clinical trial. The lawmakers provided proposed language to be inserted into the FDA’s research regulations.
“We believe it could provide a much needed tool for patients in order to gain access to trials and lifesaving drugs,” they wrote. “It is our hope this presents a more efficient pathway to market trial participation, all with no additional cost to taxpayers or government.”
Besides Swalwell and Sessions, other House Members signing the letter included Brenda Lawrence (D-MI-15); Sanford Bishop (D-GA-2); Ted Lieu (D-CA-33); Gwen Moore (D-WI-4); Martha McSally (R-AZ-2); Donald Payne Jr. (D-NJ-10); Collin Peterson (D-MN-7); Alan Grayson (D-FL-9); Buddy Carter (R-GA-1); Hakeem Jeffries (D-NY-8); Mark DeSaulnier (D-CA-11); Steve Cohen (D-TN-9); Cresent Hardy (R-NV-4); Mike Honda (D-CA-17); and Randy Forbes (R-VA-4).
Click here to read the letter in its entirety.