Tsunami Warning, Education, and Research Act of 2015

Floor Speech

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Ms. DeLAURO. Mr. Speaker, I rise in opposition to this bill. The 21st Century Cures bill aims to promote biomedical innovation and mental health, noble goals that I share. Unfortunately, this bill sets a dangerous precedent and has the potential to do more harm than good for millions of Americans.

In its attempt to speed up the drug and device approval process, this legislation neglects the very people whom clinical trials are meant to help, that is, the patients. Rather than protect those who rely on the healthcare system, it reduces the already weak regulation on medical devices, allows drugs to be approved with only limited evidence of the drug's safety and efficacy, and rushes the use of new and unproven antibiotics.

An example, 13 models of the St. Jude's defibrillators are currently being recalled for sudden battery failure that has been linked to at least two deaths, 10 people fainting, and 37 people feeling dizzy.

When the cost of our prescription drugs is skyrocketing, this bill does nothing to combat excessive prices.

Finally, this bill strips away funding from the public health and prevention fund. While the bill authorizes $4.8 billion to the NIH over the next 10 years--on average, a mere $480 million a year--this is barely a quarter per year of what the House passed last year. Let us not forget that we would need to provide $7 billion a year to keep up where we were in 2003.

There is also no guarantee that the appropriators will follow through and provide funding each year, as we have seen with the public health prevention fund, which has been used to fill appropriations shortfalls.

Illness touches us all. We owe it to the patients who depend on the standards that we set. Unfortunately, I believe the standards in this bill are both weak and dangerous. This legislation is the wrong path forward, and I strongly oppose it.

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