Striking A Balance

January 20, 2011
1:19 pm

Being a regulator is, by no stretch of the imagination, an easy job.

While taking more than their fair share of rhetorical abuse (and, yes, I’ve been guilty of that), they have the difficult task of crafting rules that reflect the intent of the legislation that enabled them, protect citizens from a variety of imaginable harms and do so without unnecessarily impeding economic growth.

In an increasingly complex world, it’s a difficult balance to strike and maintain.  That’s why President Obama’s executive order to review federal regulations is a sound and welcome action.  As the President stated, it’s essential to “strike the right balance” between protecting the public’s well-being and ensuring robust economic growth and job creation.

To that balance, I would also add the necessity to encourage innovation.

The Food and Drug Administration demonstrated good judgment in that regard this week in its rulemaking to fine-tune the 510(k) process.  The 510(k) approval process is used for medical devices that are very similar to already-approved process.  It enables manufacturers to make small improvements in a healthcare product without having to go through the lengthy and expensive approval process required of brand new innovations.

The FDA approved a number of changes to streamline and improve the 510(k) process and asked the Institute of Medicine to give its expert opinion on other proposed changes that some experts fear could slow down the approval process without delivering any real benefits to patients and healthcare consumers.

As I said, it’s not easy being a regulator, but the process is at its best when, as both President Obama and the FDA showed this week, there is an awareness that the balance must be maintained between consumer protection and innovation and economic growth.

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