House Passes 21st Century Cures Act

The U.S. House of Representatives on November 30 overwhelmingly passed the 21st Century Cures Act—a bill designed to increase funding for medical research and change the process for drug and device approvals by the Food and Drug Administration (FDA).

Although the bill, which passed in the House 392-26 and may be voted on in the Senate as early as next week, has amassed a number of bipartisan supporters—including several advocacy groups, health care industry lobbyists, and the Obama administration—it remains somewhat controversial. Among the legislation's critics are Sen. Elizabeth Warren, D-MA, and Sen. Bernie Sanders, I-VT.

The 21st Century Cures Act includes provisions for billions of dollars in new funding for the National Institutes of Health (NIH) and associated projects—provisions that are strongly supported by advocates of biomedical research. Increased funding for medical research will come, in part, from sections of the Affordable Care Act expected to be repealed following last month's presidential election. One high-profile project that will benefit from passage of the bill is the Cancer Moonshot Initiative—Vice President Biden's program to accomplish the equivalent of 10 years of cancer research within five years.

The legislation's controversy largely stems from its promise to speed up the approval of new drugs and medical devices—a goal the FDA has already been working on. More than 1,400 lobbyists—many from pharmaceutical companies with a lot to gain from faster approvals—had a hand in developing the 21st Century Cures Act and critics of the bill have expressed concerns about patient safety. In some cases, faster drug approvals result in a market flooded with expensive medications that may not work as well as expected, and could have serious side effects. If passed, the new law also would allow a drug approved to treat one condition to be prescribed for a related medical problem, without further study.

Supporters of the 21st Century Cares Act expect the new law to improve follow-up studies regarding drug and medical device approvals, as it gives the FDA more leeway to consider patient needs and opinions when making judgments about new treatments. Advocates claim the legislation will improve the role of patients in their health care.

Under the new law, the FDA would be able to fill more than 600 vacant positions by allowing the agency to offer competitive pay. If the Senate passes the 21st Century Cures Act as expected next week, President Obama could sign the bill into law by the end of 2016.

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Sourced from: NPR