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.
More articles on FDA guidelines:
FDA issues safety warning on side effects of popular antibiotics
FDA backs off of scope-cleaning machine recall
FDA releases guidance on 3D printing for medical devices
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