21st Century Cures Act Draws Concern

21st Century Cures Act Draws Concern Over Possible Lowered Clinical Standards – Pain Medicine News – Dec 13, 2016

The 21st Century Cures Act, a bill that could accelerate the drug approval process and increase funding for mental health care, drug addiction treatment and biomedical research, has been passed by a Senate vote of 94-5

Despite concerns that the bill may be more beneficial to pharmaceutical companies than to consumers, President Barack Obama is expected to sign the bill into law, after which the FDA, the National Institutes of Health (NIH), and the Department of Health and Human Services will be responsible for its implementation  

According to reports, the bill:

  • authorizes $500 million in funding for the FDA,
  • $4.8 billion in funding for the NIH and
  • $1 billion in funding to address the opioid epidemic;
  • provides funding to continue the Cancer Moonshot initiative;
  • aims to speed up the FDA approval process for drugs and medical devices, partly by giving the agency more leniency in regard to what kinds of evidence it can consider in the approval process;
  • requires the Department of Health and Human Services to “oversee a review of regulations and polices regarding the disclosure of financial conflicts of interest” over a period of two years;
  • requires the NIH to convene a group to develop recommendations to improve the “rigor and reproducibility” of research funded by the agency;
  • and includes a provision that allows hospitals serving predominantly poor patients to compare their readmission rates against similar hospitals rather than all hospitals—meant to address concerns about such hospitals being penalized for readmission rates based on comparison with hospitals serving fewer poor patients.

Not everyone is pleased with the new law because they are concerned about potential harms to patients because standards of approval are being lowered, they said.  

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