The Senate approved the 21st Century Cures Act Wednesday afternoon in a majority vote. President Barack Obama could sign it into law as early as tomorrow.
The final vote was 94 to 5.
The act covers a broad range of medical reforms and innovations, including fixes to the Food and Drug Administration’s process for approving drugs, funding for the “Cancer Moonshot” and precision medicine initiatives, and expanded access to mental health services.
It also aims to support health information technology goals, including electronic health record (EHR) interoperability and data privacy and security.
Language in the bill could force technology vendors to make their systems talk to one another, prohibiting information blocking and other practices that interfere with data-sharing that would benefit patients. In addition to EHR interoperability, it also addresses product standards and certification.
The act will help dig doctors out of the “ditch” that EHRs have put them in, Sen. Lamar Alexander (R-Tenn.), chair of the Senate Health, Education, Labor and Pensions Committee, said from the floor just before the vote.
Detractors, including Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.), say the act gives too much away to pharma companies and weakens FDA oversight.
Sanders, who voted against the act, noted in Senate floor debate yesterday that even President-elect Donald Trump was shocked to learn how much more Americans pay for prescriptions than people in other countries and that the federal government is restricted by law from negotiating drug prices. He urged fellow senators to vote against the bill.
A Los Angeles Times headline calls the act a “huge handout to the drug industry disguised as a pro-research bounty.”
If universal praise for a measure “makes your B.S. detectors twitch, you’re on the right track,” writes columnist Michael Hiltzik. “The 21st Century Cures Act is a huge deregulatory giveaway to the pharmaceutical and medical device industry, papered over by new funding for those research initiatives. The punchline is that the regulatory rollback is real, but the funding may not be—it’s subject over the next decade to annual appropriations by Congress that might never come.”
A PBS NewsHour piece, meanwhile, lists the “winners and losers” under 21st Century Cures. Not surprisingly, big pharma and medical device manufacturers make the “winners” list. Real-world evidence for approval of new indications for FDA-approved drugs lands in the win column, along with patient advocacy groups.
Losers include randomized clinical trials: “Currently the gold standard for testing drugs and devices for safety, the adoption of real-world evidence standards may indicate that randomized clinical trials will become less important for drug and device approval,” the article notes.
On Monday, the Senate voted to rename the part of the bill that will provide $1.8 billion over 7 years to fight cancer after Joe Biden’s son, Beau Biden, who died of cancer in 2015. The vice president, presiding over the session, teared up as he responded to the formal motion: “Without objection.” He later told reporters he didn’t know of the plan.
“This is one of the last times I’ll preside over an actual vote count,” Biden said on a video shot before the session and posted to Twitter. “This is the beginning of a fundamental change … the urgency with which we treat the need to cure cancer and to turn some cancers into chronic diseases.”
A broad scope
The House voted 392 to 26 in favor of the landmark legislation last week. Rep. Erik Paulsen (R-Minn.) said the legislation is an “innovation game-changer … 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.”
The wide-ranging measure (PDF) includes these and other 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 FDA to streamline the clinical trial process and hire new staff.
- It 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.