The 21st Century Cures Act: An Unclear Advance

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Critics worry that changes to the FDA’s drug approval process could lead to increased off-label prescribing and the marketing of questionable therapies.
Critics worry that changes to the FDA’s drug approval process could lead to increased off-label prescribing and the marketing of questionable therapies.

The United States 21st Century Cures Act secured billions in federal funding for cancer and other medical research over the coming decade—assuming congressional support is maintained—experts told Cancer Therapy Advisor.

Senate majority leader Mitch McConnell (R-KY) called it “the most significant legislation passed by this Congress.”1 The law, passed by the US Senate by a vote of 94 to 5, approved $4.8 billion in National Institutes of Health (NIH) funding over the coming decade, $1.5 billion for President Obama's Precision Medicine Initiative, and $1.8 billion for Vice President Biden's cancer “moon shot” initiative.2-4

The Precision Medicine Initiative is aimed at the development of patient-centric testing and more precisely-targeted therapies for cancer and other diseases. The “moon shot” is intended to accelerate the translation of experimental cancer research into clinical practice.

The American Society of Clinical Oncology praised the new law as landmark legislation that will save lives.5

The Cures Act has “energized the community—all sectors: patients, academic, government, industry—to come together and work together,” said Elizabeth Marion Jaffee, MD, deputy director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore, Maryland. Dr Jaffee is co-chair of the Blue Ribbon Panel for Vice President Joe Biden's National Cancer Moonshot Initiative. She attended President Obama's signing of the law on December 13.

“Cancer is not a political issue,” Dr Jaffee told Cancer Therapy Advisor. “It was a wonderful thing to see that our congress could come together. Cancer affects everyone; everybody in congress knows somebody with cancer or who has died of cancer, or survivors who wind up suffering because we don't have good treatments for survivors.”

The law's future implementation involves “a lot of ‘ifs',” she acknowledged. “We don't know what is going to happen with the new administration. We don't know for sure that it won't be repealed or altered.”

Implementation and support for the Cures Act will “take a lot of advocacy at a lot of levels, to make sure that with the new congress and administration, they understand the importance of this bill,” Dr Jaffee said. “We have the ability to do it. The science is right but the only way to make quick enough to make a difference if we all come together.”

Yet some critics voiced concerns that the law gives considerable discretion to the politically-appointed head of the NIH in distributing the Cures money.

“The NCI [National Cancer Institute] has a long history of distributing research money fairly,” Dr Jaffee asserted. “The NCI needs mechanisms that are more flexible and nimble. We're trying to make differences in 5 years that would have taken 10. Patients are depending on this; we have to do it quickly.”

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