Why the 21st Century Cures Act is unsafe legislation

The 21st Century Cures Act contains good ideas for streamlining development and evaluation of new drugs and devices, but other provisions could lead to an approval process that is less safe, according to a perspective article in The New England Journal of Medicine.

Jerry Avorn, a professor of medicine at Harvard Medical School, and Aaron Kesselheim, an associate professor of medicine at Harvard, write that the 21st Century Cures Act instructs the U.S. Food and Drug Administration to consider nontraditional study designs and methods of data analysis to further speed approvals.

In addition, they foresee problems with encouraging the use of "shorter or smaller clinical trials" for devices. 

The new law would redefine the evidence on which high-risk devices can be approved to include case studies, registries and journal articles rather than more rigorous clinical trials, Avorn and Kesselheim say. Other language would allow device makers to pay a third-party organization to determine whether the manufacturer can be relied on to assess the safety and effectiveness of changes it makes to its devices, and from then on be allowed to continue to assess its own products.

"Patients and physicians would not benefit from legislation that instead of catapulting us into the future, could actually bring back some of the problems we thought we had left behind in the 20th century," they say.

America's Health Insurance Plans recently sent a letter to Sen. Bob Casey (D-Pa.) warning about the danger of premature FDA approval for devices and lax oversight after they hit the market.

The FDA in January published draft guidance proposing to regulate medical device accessories based on risks they present when used as intended with their parent devices, and not to regulate products intended only for general wellness.

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