What the 21st Century Cures Act Means for Women’s Health

Before signing the omnibus healthcare bill known as the 21st Century Cures Act in December, President Barack Obama said it could help cure Alzheimer’s disease. And he didn’t stop there.

“It could end cancer as we know it and help those seeking treatment for opioid addiction,” Obama said. “It’s an opportunity to save lives, and an opportunity we just can’t miss.”

Congress passed the bill with overwhelming bipartisan support. And like any piece of legislation gaining large majorities from both parties, it contained compromises.

The law calls for a $4.8 billion increase to the National Institutes of Health budget over 10 years. That includes $1.8 billion for Vice President Joe Biden’s “cancer moonshot” to speed research toward a cure, $1.6 billion to tackle Alzheimer’s and other brain diseases, and $1 billion over two years in state grants to help people addicted to opioids. The law also calls for $500 million in new funding over 10 years for the Food and Drug Administration.

But the money will require annual appropriations by Congress, an arrangement that leaves the door open for new and future members to use the money to fill budgetary shortfalls. And opponents of the bill, including U.S. Rep. Rosa DeLauro, D-Conn., and Sen. Elizabeth Warren, D–Mass., argued that the provisions intended to speed the FDA approval process for new drugs and devices put lives at risk.

“The 21st Century Cures Act, in an attempt to expedite the drug and device approval, forgets about those who the science and clinical trials are meant to help — the patients,” DeLauro said. “Rather than protect those who rely on our health care system, this bill reduces the already weak regulations on medical devices, allows drugs to be approved with only limited evidence of the drug’s safety and efficacy, and rushes the use of new and unproven antibiotics.”

The 21st Century Cures Act forgets about those who the science and clinical trials are meant to help.

U.S. Rep. Rosa DeLauro, D-Conn.

Women’s Health Research at Yale Director Carolyn M. Mazure, Ph.D., applauded the law’s attention to funding vital science aimed at improving and saving lives struck by deadly diseases. But she also expressed a need for great caution around the measures designed to accelerate approval of treatments, noting that it is difficult to confirm safety and efficacy based on preliminary data. She called for careful attention to how the law is implemented, particularly because it’s very difficult to remove something from the market once approved.

“There are certainly possible benefits to be gained by speeding therapies and devices through the approval process to more quickly help patients with few or no current alternatives,” Mazure said. “But we must not do so at the expense of public safety or of advancing our knowledge of how treatments affect sub-groups within our heterogeneous population.”

In addition, the law supports NIH requirements for reporting the proportion of female clinical research subjects to better track efforts underway in NIH-funded studies to fully consider sex and gender as a variable. The law also creates a task force to explore research specific to pregnant and lactating women, a development that Dr. Mazure supports while pointing out that biomedical science should not focus entirely on women’s role in reproduction.

“There is progress in this law as it pertains to marshalling the resources necessary to address the health challenges we face,” she said. “But the FDA and NIH implementation of the law through guidance and oversight will determine if the resources are well spent.”

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For questions, please contact Rick Harrison, Communications Officer, at 203-764-6610 or rick.harrison@yale.edu.

This article was submitted by Carissa R Violante on March 17, 2017.

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Carolyn M. Mazure

Norma Weinberg Spungen and Joan Lebson Bildner Professor in Women's Health Research and Professor of Psychiatry and of Psychology