In a Boost for Real-World Evidence, Senate Approves 21st Century Cures Act

In bygone says, legislators like Democratic Sen. Henry “Scoop” Jackson and Republican Sen. Robert Dole could hammer out deals, and move legislation along. That cooperation has been lost in recent decades, but perhaps not forever. The legislative approval process for the 21st Century Cures Act (not to mention MACRA earlier this year) proves that bipartisan support can still function in the nation’s capital.

In a 94 to 5 vote yesterday, the Senate approved the Act, the Washington Post reports. It now heads to President Obama, who says he will sign it. The Senate’s vote follows a 392 to 26 “yea” vote in the House of Representative last week. The Act speeds FDA approval for drugs and medical devices and allows the agency to include real-world evidence in the approval process. Drug companies will be able to submit drug data summaries, instead of the clinical trials.

That idea doesn’t appeal to everyone, and progressive Senators Bernie Sanders and Elizabeth Warren, who voted against, warned that the Act makes too many concessions to pharmaceutical companies. Public Citizen, a activist group that opposed the bill, said it amounted to giving drug manufacturers and the medical device industry an early Christmas present and “comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices.”

In a statement, President Obama said that the “legislation advances the progress we've made in improving the Food and Drug Administration’s drug development process by, for example, making sure patients' voices are part of those decisions.”

He also said that, “The bipartisan passage of the 21st Century Cures Act is an example of the progress we can make when people from both parties work together to improve the health of our families, friends and neighbors.”

Source: Washington Post