Passed by House, 21st Century Cures Act Could Spur Advances, Weaken FDA

Daniel Hayes, MD

Viewed by some as a boon for precision medicine, an Alzheimer’s cure, brain research, and opioid abuse prevention, but also seen as weakening the FDA’s regulatory power, the $6.3 billion 21st Century Cures Act passed overwhelmingly in the House Wednesday by a vote of 392-26.

The legislation has strong support from the White House, as it furthers several initiatives favored by President Obama, and is expected to be voted on by the Senate early next week. Whereas 21st Century Cures is expected to spur drug development and medical device innovation, the bill is criticized for potentially weakening the FDA’s ability to scrutinize new drug applications and regulate medical devices.

Two years in the making, the bill is promoted by supporters as a way to modernize the FDA’s approvals mechanisms in order to bring needed medicines and devices to market faster for the patients who need them. Patient advocacy groups and a battalion of pharmaceutical industry lobbyists have argued for passage of the bill. Opponents contend the legislation opens the door to abuse by the pharmaceutical and medical device manufacturing sector.

Controversial elements of the bill include “summary level” reviews for new drug indications, enabling pharma to submit their own analyses of a drug’s merits rather than supplying the FDA with raw data that enables the regulatory body to draw its own conclusions.

In a statement, the White House acknowledged imperfections in the bill, but true to Capitol Hill style has taken the position that 21st Century Cures is a compromise package that has potential to do a lot of good.

“Like all comprehensive legislation, the bill is not perfect, and there are provisions the administration would prefer were improved, but the legislation offers advances in health that far outweigh these concerns. The Senate should promptly pass this bill so that the president can sign it,” the White House said Wednesday.

Democratic support for the bill is by no means unanimous. “It's time for Congress to stand up to the world's biggest pharmaceutical companies, not give them more handouts," said Sen Bernie Sanders (D-VT), in an argument prior to the House vote.

The initiative was spearheaded by Rep Fred Upton, (R-MI), chairman of the House Energy and Commerce Committee with the help of Rep Diana DeGette, (D-CO). “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.

The bill will provide the National Institutes of Health with $4.8 billion over 10 years, in part to ensure the continued funding of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, an ambitious effort to map and understand the functioning of the human brain, leading to new cures and treatments, in part for Alzheimer’s and epilepsy. Obama’s Precision Medicine Initiative also would receive funding for the focus on tailoring medicine to address individual differences and response potential in patients, as would Vice President Joe Biden’s Cancer Moonshot effort to double the pace of cancer drug discovery.

Allocations include $1.8 billion for the Moonshot; $1 billion for the opioid epidemic; $1.5 billion for the BRAIN Initiative; $1.5 billion for the precision medicine; and $500 million to accelerate drug approval processes and access to medical devices for patients. Bipartisan mental health reforms also will be funded.

ASCO President Daniel Hayes, MD, praised the House for the passage of the bill. “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.”

Sen Elizabeth Warren, (D-MA) 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.

Rep Frank Pallone Jr. (D-NJ) also worked to advance the legislation. In an interview with CURE last year, Pallone explained the impetus for 21st Century Cures came from advocacy groups who visited him. “They usually say that they would like to see some innovative program, so that there is more money for research or expedited approval,” Pallone said.

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