Speeches & Floor Statements

Opening Statement: Alexander Holds Hearing to Ensure Patients Benefit from 21st Century Cures Law

Posted on December 7, 2017

In 2007, Doug Oliver, a computer programmer, began to have trouble seeing and, after a near accident, had his driver’s license taken away and was declared legally blind.

The culprit was a rare form of Macular Degeneration.

Doug moved to Nashville, where his doctor at the Vanderbilt Eye Institute told him that while there were no cures, Doug could search online for a clinical trial.

Doug found a regenerative medicine clinical trial in Florida, where doctors took cells out of the bone marrow in his hip, spun them in a centrifuge, and then injected those into his eye.

Three days later, he began to see.

His eyesight eventually improved enough to get his driver’s license back—and enough that he became an effective advocate for more support for regenerative medicine, which we included in the 21st Century Cures Act.

Earlier this year, Doug gave me the cane he’d used while he was blind. He said: “I don’t need it anymore.”

When Congress passed the 21st Century Cures Act, we hoped to unleash medical innovation and give Americans more access to life-changing treatments and cures, so more Americans could experience medical miracles.

It is especially appropriate to be having this hearing today because it marks the one-year anniversary of the Senate passing Cures.

When it became law last December, I said that President Obama had signed a second Christmas miracle. In 2015, it was the Every Student Succeeds Act, the law fixing No Child Left Behind. Last year, it was the 21st Century Cures Act, which Majority Leader McConnell called “the most important legislation” Congress passed last year.

I have often said of the Every Student Succeeds Act that a law is not worth the paper it’s printed on if it is not implemented properly.

I intend to ensure Cures is also implemented properly, and this committee began our oversight hearings on Cures with a hearing in October on the Electronic Health Records provisions and, in addition to today’s hearing, we will continue our oversight with another hearing on the mental health provisions next Wednesday.

Today we are hearing from Dr. Collins and Dr. Gottlieb on the provisions related to biomedical research.

We are fortunate to have two talented leaders who know their agencies, are widely respected in Congress, and capable of getting results.

While the legislation included provisions to improve electronic health records, resources to fight the opioid epidemic, and the first update to mental health programs in a decade, the major purpose of the legislation was to provide additional resources and authorities to speed drugs and devices through the research and development process into doctors’ offices and patients’ medicine cabinets, while ensuring the FDA gold standard of safety and efficacy.

It is not an overstatement to say that the 21st Century Cures Act has the potential to affect virtually every American family by taking advantage of breathtaking advances in biomedical research.

Dr. Collins, at a Senate Appropriations subcommittee hearing in 2016, you have offered “bold predictions” for future major medical advances if we continue funding NIH and ensure FDA has the tools it needs.

One prediction is that scientists will find ways to identify Alzheimer’s before symptoms appear as well as how to slow or even prevent the disease. Alzheimer’s causes untold family grief and costs $259 billion a year.

Another prediction is using a patient’s own stem cells, doctors could rebuild his or her heart. This personalized heart would make transplant waiting lists and anti-rejection drugs obsolete.

Dr. Collins, you have made other predictions that are equally breathtaking:

The development of an artificial pancreas for diabetes patients

A Zika vaccine, a universal flu vaccine and an HIV/AIDS vaccine available within the decade.

New non-addictive pain medicines to help patients as we continue to battle the opioid crisis that kills 91 Americans every day.

The 21st Century Cures law put in place policies that will fund biomedical research at a time of limitless opportunity to help make Dr. Collins’ predictions a reality.

Today, I want to find out find out from Dr. Collins and Dr. Gottlieb – those leading this charge –how implementation of the law is going.

For example, Cures included a surge of one-time funding of $4.8 billion for the National Institutes of Health, including money for the Precision Medicine Initiative, Cancer Moonshot, and BRAIN Initiative.

I know from talking with Vanderbilt University that the Precision Medicine Initiative – the plan to map the genomes of 1 million volunteers to help researchers develop treatments and cures tailored to a patient’s genetics, environment, and lifestyle – has already begun enrolling patients less than one year after the program began.

In addition to PMI, I am curious how the funding has been spent, and when and how you plan to keep Congress informed of your results.

Cures required a process to look at burdensome regulations on researchers. I would like to hear if this is helping researchers spend more of their time and money on research and less on administrative tasks.

Cures also put in place policies at the FDA to move safe and effective treatments and cures through the regulatory process more rapidly and at a lower cost.

For example, Senators Burr, Bennet, and Hatch worked on a breakthrough provision for devices, modeled after a breakthrough provision for drugs.

The first breakthrough approval was just last week for an exciting cancer diagnostic.

Senators Isakson and Casey worked on removing red tape from the review of combination products.

And I worked with Senator Murray to make sure FDA had the authority to hire and pay scientists to keep up with the rapid rate of innovation.

21st Century Cures also added $30 million to support regenerative medicine and an accelerated pathway for these treatments at FDA—so we can hear more stories like Doug Oliver’s.

FDA has begun implementing these provisions and I look forward to hearing how FDA and NIH are working together to make sure the funding and authorities for regenerative medicine are helping to advance this important work, while ensuring bad actors do not take advantage of the hope of this exciting field to harm or defraud patients.

It is going to be difficult to cover everything today, but I look forward to hearing about the progress being made to unleash medical innovation and bring new drugs and devices to patients.