House OKs 21st Century Cures bill; Senate votes next week

In a rare show of bipartisan support, the House of Representatives Wednesday passed the 21st Century Cures Act, legislation aimed to accelerate the Food and Drug Administration’s process for approving drugs, fund the “Cancer Moonshot” and precision medicine initiatives, and expand access to mental health services.

The House voted 392 to 26 in favor of the landmark legislation, an amendment to a Senate amendment of H.R. 34, the Tsunami Warning, Education and Research Act of 2015. It now moves on to the Senate, which is expected to vote on the bill early next week.

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The wide-reaching measure (PDF) includes several healthcare provisions:

• It provides $4.8 billion to the National Institutes of Health, which includes $1.8 billion to fund the “Cancer Moonshot” to accelerate cancer research; $1.4 billion for the Precision Medicine Initiative to drive research into the genetic, lifestyle and environmental variations of disease; and $1.6 billion for the BRAIN initiative to improve understanding of diseases like Alzheimer's and speed diagnosis and treatment.
• It gives $500 million to the Food and Drug Administration to streamline the clinical trial process and hire new staff.
• It also provides $1 billion in grants to states to prevent opioid abuse
• The bill also aims to improve mental health programs, including integrating mental health services into primary care settings and expanding access to mental health treatment and services.

“This bipartisan initiative today gives patients new hope,” said Rep. Erik Paulsen (R-Minn.) during remarks on the Senate floor prior to the vote. “It supports more NIH research, it streamlines the regulatory approval process and it gives patients more input in the treatment and delivery process.”

Furthermore, he said, it is an “innovation game changer, it is a once-in-a-generational transformational opportunity to change the way we treat disease. It expedites the discovery, the development, and the delivery of new treatments and cures and ensures that America will be a leader in the global fight for medical innovation.”

Not everyone was on board, however. Rep. Lloyd Doggett (D-Texas) voted against the measure because he said that though the bill attempts to address the need for research funding, it doesn’t guarantee the money: “There may be bipartisan agreement, but there is not a bipartisan advancement."

He also said the revised version of the bill grants all of big pharma’s “wish lists” and doesn’t tackle rising drug costs. Indeed, Doggett said it was appropriate that the medical cures bill is packed into a larger measure called the Tsunami Warning Bill because people who rely on lifesaving drugs and want to fill a prescription have been “buried in one wave, after another wave, after a giant wave of pharmaceutical price gouging. Whether it’s an EpiPen for a child who is going to have an allergic reaction, whether it’s for insulin for someone who is diabetic and relies on that insulin, whether it’s an oncology drug that costs over $100,000, it is wave after wave of a tsunami of price gouging.”

Lawmakers, however, are optimistic that the bill will pass the Senate, despite vocal opposition from Sen. Elizabeth Warren, D-Mass., who intends to fight the bill. She says money won’t be available unless Congress passes more bills to allocate funding to specific projects. Warren also said that the other provisions are “huge giveaways” to the pharma industry.

But the White House urged the Senate to promptly pass the bill. While “the bill is not perfect, and there are provisions the Administration would prefer were improved, the legislation offers advances in health that far outweigh these concerns,” according to a statement issued by Office of the Press Secretary.