"First Things First: Fix the FDA" (From Those Who Practically Destroyed It)

Newt Gingrich, Andrew von Eschenbach and Wayne Oliver, of the Center for Health Transformation, wrote a blog post recently that you might find interesting.

In the context of critiquing plans to create a new federal agency for translational research, they advocate that FDA be completely rebuilt, so that it, in effect, stops slowing innovation, destroying U.S. jobs and causing pharma's pipeline to dry out.

We need a new FDA, built on transparency and science, they write compellingly.

But wait, isn't that what Drs Hamburg (and previously Sharfstein) have been working on?

And wasn't Mr. Gingrich on the team who practically gutted the Agency for decades? Even eight years ago, budgets were so thin that getting approval for scientific training courses was rare, some insiders confided a few years ago.

And isn't Mr. von Eschenbach the one who failed to support change agents within FDA, (giving one of them an exalted, but empty title, and only very briefly) and programs like Critical Path, and who caused "transparency" to take a nose dive with his "locker room" analogy and comment?

It's easier to destroy (or to talk about destroying) than to build.

FDA is always wrong, it seems---should it fail to be a model policeman, it lands in the cross-hairs of Representative Darrell Issa and others...(only, at the same time, Issa wants it, and other regulators, to stop meddling in business)

So, when it does its job, it's labelled as being against progress.

When FDA reviewers fail to approve something (think thalidomide and Frances Kelsey), it's for good reasons.

Perhaps those at the Center for Health Transformation would agree to take one of the very innovative therapies that FDA has decided not to approve, for a year, to make their point?

If political conservatives continue to blame all of pharma's ills on FDA and the regulatory process, how will the industry ever improve?

AMS

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