Jeff Shuren, MD, has brought a lot of changes to FDA’s Center for Devices and Radiological Health, but there are those who think Shuren has not gone far enough while others think he’s gone too far. None of this would matter so much but for the potential for a GOP take-over of the White House.

It’s no secret that Shuren’s administration of CDRH has not lacked for controversy, but what some might not realize is the enormous pressure Shuren is under.

So what you say?

There are several members of Congress who are quite critical of CDRH, but maybe none more so than Sen. Richard Burr (R-North Carolina), who blasted Shuren for the latter’s criticism of industry over device application review times in a House hearing early in 2011. Burr was also less than enamored of some features of the device user fee agreement and he promised to keep up the scrutiny. Shuren also had to walk back a European patient/guinea pig remark made early in 2011 as well, a faux pas that could not have helped his image inside the Beltway given the hackles it raised on the other side of the Atlantic.

Another factor, one which many are keenly aware of, is the e-mail monitoring program undertaken by CDHR to deal with reviewers who had released confidential application documents to the White House and members of Congress. The news has not won CDRH any fans on Capitol Hill, including Republican members of both the House and the Senate. Sen. Chuck Grassley (R-Iowa) and Rep. Darrell Issa (R-California) have been nosing around into the matter, and a GOP take-over of the Senate would not render a body that looks favorably upon Shuren.

One of the sources of pressure may be the recent arrest of Bill Maisel, MD, who came on board at CDRH as the device branch’s director for science in 2010. Maisel had appeared several times on Capitol Hill to testify regarding medical device safety. He testified at a House hearing in 2009 on the subject of legislation that would have put an end to the pre-emption of state regulatory mechanisms for PMA medical devices, but perhaps worse yet is that critics of the CDRH e-mail monitoring program are alleging that Maisel had a hand in the program. Double oops.

If the GOP candidate for the Oval Office, Mitt Romney, is unaware of all this just yet, he’d probably find out about it shortly after taking office, assuming he wins in November.

Finally, the GOP platform includes a call to “reform the FDA so we can ensure that the U.S. remains the world leader in medical innovation.” The statement does not explicitly call out Shuren, but it hardly comes across as a ringing endorsement of recent goings-on at CDRH.

Still not convinced? Some will remember Tom Scully, formerly the administrator at the Centers for Medicare & Medicaid Services. Scully oversaw a lot of reforms at CMS and was himself embroiled in a number of controversies. His job at CMS lasted two years and he lost his job under the same administration that brought him into the job. Shuren is facing a different administration with an entirely different outlook on the role of government.

So the question remains: Is Jeff Shuren’s job on the line come Election Day 2012?