21st Century Cures a bipartisan battle on disease

With passage in the House of Representatives of the 21st Century Cures Act that I co-authored with Michigan Republican Rep. Fred Upton, we’re just two steps away from a major victory for U.S. research into causes and treatments for disease. The next few days will decide its fate as the U.S. Senate prepares to vote.

More than 700 groups representing patients, health care providers, researchers and others have voiced support for the bill – as has the White House, which provided its enthusiastic endorsement before and just after the House approved it by a vote of 392 to 26.

And this very newspaper weighed in, too, noting that the measure is intended to make federal review of research more efficient.

This is a watershed moment in this country for biomedical research. With this bill, we bring hope to millions of patients who suffer from cancer, Alzheimer’s, diabetes and a host of other ailments.

Upton and I started working on this measure three years ago. We traveled the country together to gather information about much-needed reforms, and we had tremendous participation in the process from patients groups, medical professionals, academia, and federal and state health care authorities. The consensus view was especially important as we strove to strike a balance between clearing away the hurdles to progress and ensuring safety and efficacy of drugs and devices remain our paramount standard.

All of this led to our original bill, which passed the House in July 2015 by 344 to 77. We have worked tirelessly in a bipartisan, bicameral way since then to improve and expand the bill and to smooth the way toward passage through the Senate and on to the president’s desk.

The result will help overcome obstacles to medical progress — from discovery to development to delivery — through investing in innovation, incorporating the patient perspective and modernizing clinical trials.

Among the key provisions, this consensus version of the bill will:

•Provide $4.8 billion to the National Institutes of Health, including money for Vice President Biden’s cancer moonshot initiative, and including money for precision medicine and the brain initiative.

•Allocate almost $1 billion in grants to the states, including Colorado, to address the urgent opioid crisis in this country.

•Remove the silos at the Food and Drug Administration by transitioning it to a disease-centric approach, and it gives $500 million so the FDA can implement these reforms.

•Include all important mental health legislation that we’ve worked to shape and to pass into law for a long time.

•Catalyze cutting-edge research by supporting potentially transformative efforts.

21st Century Cures will help scientists in our region and throughout the United States work together on research projects. At the moment, each school has to follow its own set of protocols for clinical and field studies, even when the schools collaborate.

This cumbersome process can be streamlined so that schools such as the University of Colorado School of Medicine and other research institutions can collaborate without following separate approval tracks for their research models.

All of this, done in close consultation with the agencies that are responsible for the safety of medical research in this country, will bring hope to millions of Americans.

At a time of heightened acrimony in Washington, and in the wake of one of the most rancorous elections we’ve ever had, it’s wonderful that we can come together to find cures that affect so many patients and their loved ones.

Disease doesn’t discriminate according to political party. It knows nothing of claims and counter-claims. It responds only to carefully developed treatments and cures.