When the 21st Century Cures Act passed the House in July 2015, public health experts began to warn against a connection between one measure included in the act, a huge increase in medical research funding, and Food and Drug Administration product approval changes, according to The Wall Street Journal.
Although supporters see the connection between increased National Institutes of Health funding and altering the approval processes of drugs and medical devices as a way to promote innovation and research, the inverse opinion suggests the situation creates a financial incentive to make the approval process more lax.
One former FDA commissioner told WSJ that linking the promise of research funding to a requirement to lower FDA standards is akin to making a deal with the devil. However, those in support of the standards change say the bill updates old regulations and doesn't lower the bar for approval, but rather establishes a tiered approval system.
A Senate version of the bill, which has gotten more pushback than the proposal that received approval in the House, is in the works, according to WSJ. If it were to pass, the two chambers would need to collaborate on a final version before sending it to the White House for approval.