Lance, McCaul measures pass as part of House-renewed FDA Act

The U.S. House passed the FDA Reauthorization Act on Wednesday, which included provisions championed by U.S. Reps. Leonard Lance (R-NJ) and Michael McCaul (R-TX) to improve clinical trials and pediatric cancer research.

The legislation, which also included the reauthorization of the Food and Drug Administration’s critical user fee programs, now heads to the U.S. Senate for consideration.

Specifically, the bipartisan effort by Lance, who teamed up with Rep. Diana DeGette (D-CO), to improve clinical trials, was included in the legislation and unanimously passed as part of the overall act.

The measure would improve the way clinical trials are conducted to better track the patient experience and ultimately help create better medicines and devices for the patient market, according to Lance and DeGette, who are members of the House Energy and Commerce Committee that crafted the FDA Reauthorization Act.

“Clinical trials are where we discover cures and therapies that will save lives,” Lance said. “We need to measure both the physical and psychological impacts of disease so the most informed decisions can be made on trial effectiveness.”

The FDA reviews data from clinical trials to determine the safety and efficacy of new drugs, so he and DeGette worked together to include provisions with new instructions for improving data collection on the physical and psychological effects of disease and for increasing participation in clinical trials.

“When patients participate in clinical trials, they are putting confidence in their team of doctors for what could be their best hope against challenging diagnoses. We need to make sure clinical trials are as strong as they can be,” said Lance.

Similarly, McCaul and Rep. G. K. Butterfield (D-NC) had their bipartisan bill, the Research to Accelerate Cures and Equity (RACE) for Children Act, also pass as part of the FDA reauthorization.

“I believe it is incumbent upon each of us – especially those elected to serve – to do our part to rid this world of cancer, for the sake of my children and yours,” McCaul said in floor speech in support of the bill on Wednesday.

McCaul also said that when he first became a member of Congress, he founded the Childhood Cancer Caucus to give a voice to the more than 15,000 children diagnosed with cancer each year and the many survivors who face a lifetime of medical challenges.

Having the RACE Act passed “is a great first step in providing these children access to the treatments they deserve,” he said.

Overall, the FDA Reauthorization Act would reauthorize the FDA’s important user fee programs to ensure the federal agency has the tools needed to more swiftly deliver safe and effective drugs, devices and treatments to patients.

House Energy and Commerce Committee Chairman Greg Walden (R-OR) said the act is designed to help bring lower-cost generic drug alternatives and biosimilars to market faster. In turn, this will increase competition and lower drug costs, he said.

“And it will streamline the process for reviewing and approving new treatments and cures for patients, ultimately delivering new and innovative therapies, drugs and devices to patients more quickly,” Walden added.