21st Century Cures Act Passes in the House, Expediting FDA Approvals and Funding for the Cancer Moonshot

After two years of negotiations, the United States House of Representatives has overwhelmingly passed the 21st Century Cures Act.

By a vote of 392-26, members agreed to move the bill, which gives more than $6 billion for cutting-edge health initiatives, including an allocated 1.8 billion dollars to support Vice President Joe Biden’s Cancer Moonshot program, through the House.

The initiative was spearheaded by Republican Fred Upton, Sixth Congressional District of Michigan, chairman of the House Energy and Commerce Committee with the help of Diana DeGette, a Democrat, First Congressional District of Colorado. “21st Century Cures is the innovation game-changer that patients, their loved ones and the nation’s researchers and scientists so desperately need," the co-authors of the bill said in a statement.

In addition to funding for the Moonshot initiative, the 21st Century Cures Act also allocated one billion dollars to fighting the opioid epidemic; 1.5 billion dollars for the BRAIN Initiative that finds new ways to treat, cure and prevent brain disorders such as Alzheimer’s and epilepsy; 1.5 billion dollars over 10 years for the Precision Medicine Initiative; and 500 million dollars to the U.S. Food and Drug Administration (FDA) over 10 years to speed up the drug approval process and access to medical devices for patients. It also includes bipartisan mental health reforms.

The president of the American Society of Clinical Oncology (ASCO), Daniel Hayes, M.D., praised the House for the passage of the bill.

“The U.S. House of Representatives took a significant step forward to accelerate the pace of bringing promising new treatments to patients — including the 1.6 million Americans diagnosed with cancer each year,” Hayes said in a statement. “ASCO is particularly pleased that the bill takes a step forward in addressing the interoperability of electronic health records (EHRs) and that the legislation puts restrictions on intentional information blocking,” he added. “These much-needed improvements will make it easier to coordinate patient care across a variety of medical providers – and advance important efforts on big data and precision medicine.”

While the bill cleared the House, it has not come without controversy surrounding some components of the legislation regarding the FDA. Some patient advocates worry that safety will be sacrificed in the rush to push drugs to the markets. In a press release, The White House urged the Senate to pass the bill. However, the vote, which is set to happen early next week in the Senate, may not come without a battle.

Elizabeth Warren, U.S. senator from Massachusetts, called the bill “extortion,” and added that the legislation had been “hijacked” by the pharmaceutical industry. She vowed to fight it if it reached the Senate.

Democrat Frank Pallone, Jr., Sixth Congressional District of New Jersey also worked to help advance this legislation. In an interview with CURE last year, Pallone, Jr. explained the impetus for the 21st Century Cures Act came from advocacy groups who visit him both locally and in Washington, DC.

“They usually say that they would like to see some innovative program, so that there is more money for research or expedited approval,” said Pallone, Jr.

On the House floor, Pallone, Jr, said, “This is not a perfect bill, but after much consideration I believe the benefits outweigh my concerns and I support its passage.”