What needs fixing and how can we fix it?
The FDA doesn’t regulate in a vacuum. We need to listen to all our stakeholders – the American people who we protect and the industries we regulate. One important way we do this is by a process called retrospective review of regulations.
So what does this mean? As part of a process begun by President Obama, the FDA today announced that we are formally asking for submissions on how to improve existing regulations. Retrospective reviews like this really help us focus on how we can improve our regulations and give us invaluable insights on how we, and those we regulate, can be more innovative and take advantage of innovation as we work to protect and promote the public health.
For FDA, review of regulations is grounded in straightforward principles. First, regulations should change with the times. Second, they should not impede innovation and, if possible, foster it. Third, the effort they call for (the burden or cost of complying) should be reasonable. Fourth, they should not be ineffective. In other words, regulations should make sense, and if they don’t, we should change, strengthen, clarify, streamline, or revoke them.
That’s where you come in.
We want to hear from you. Help us identify areas to focus and improve. Where are our regulations ineffective? Do our regulations address current public health challenges? Where do we need to update our regulations? Can we revise them in ways that makes them less burdensome without making them less effective? Where can we be more flexible? How we can put greater emphasis on innovative scientific approaches? Do we have regulatory requirements that are redundant, inconsistent or needlessly overlap?
We’re most interested in big ideas, ones that identify regulatory problems that have the greatest impact on the public health.
If you want to help us with this important task, you can learn more by visiting the Federal eRulemaking Portal and following the instructions for submitting comments.
We are looking forward to your suggestions. Thank you very much – Leslie
Assistant Commissioner for Policy (Acting)