FDA Medical Device Regulator Resigns: Should Health IT Vendors Be Nervous?

I believe HIT vendors should be getting nervous.

HIT vendors have long enjoyed a protected status and uncritical accommodation relative to other medical device industries and pharma, with contracts that gag medical professionals from disclosing defects that can mislead and cause patient harm, and that absolve the HIT vendors themselves from liability. HIT is, in fact, a virtual medical device that other important countries (e.g., in the EU) are already moving towards regulating in a manner similar to physical medical devices.

The HIT vendor "special status" may be coming to a close, and here is a sign in that direction:

Wall Street Journal
August 12, 2009
FDA Medical-Device Regulator Resigns

By ALICIA MUNDY

WASHINGTON -- The Food and Drug Administration's top medical-device regulator said Tuesday he is resigning.

The departure follows internal dissent over device-approval decisions that the regulator's critics said were too friendly to industry.

Daniel Schultz said his move comes "by mutual agreement" with FDA Commissioner Margaret Hamburg, who took office in May. [In other words, he was asked to leave - ed.]

An FDA spokesman said Dr. Schultz's decision came as the result of talks with Dr. Hamburg, and had nothing to do with any specific issue related to a device's approval process.

Drug Chief at the FDA Is Accused of Conflict

Dr. Schultz has worked at the FDA's Center for Devices and Radiological Health for 15 years and led it for the past five years.

Sen. Chuck Grassley (R., Iowa) held hearings two years ago on Dr. Schultz's approval of a nerve stimulation device to treat depression, approval that came over the objections of several FDA doctors. Mr. Grassley complained at the time that science was being ignored in favor of industry. Dr. Schultz said his decision was based on sound medical data.

In March, Sen. Grassley opened an investigation into a knee-surgery device made by ReGen Biologics Inc., after The Wall Street Journal reported that Dr. Schultz approved it over the objections of numerous FDA scientists and reviewers.

FDA Deputy Commissioner Joshua Sharfstein said in May that the agency would re-examine the approval process for the ReGen knee device to see if proper procedures were followed.

A group of nine device division employees wrote to the House Energy and Commerce Committee last October to complain that the division's leaders had approved devices despite formal safety and efficacy concerns raised by FDA. They also alleged some scientists who objected to the decisions faced retaliation from leaders of the device division. [This sounds much like the world of health IT, where whistleblowers on HIT safety may find themselves persona non grata - ed.] The FDA at the time declined to comment.

These are serious matters, and under the Obama administration I see a replacement as being far less friendly and far less likely to accommodate both physical and virtual (i.e., HIT) clinical device makers.

The irony is that Medical Informatics specialists such as myself and like minded colleagues have offered help to the HIT and medical device vendors and purchasers repeatedly over the years to improve quality of their products in a substantive, medical informatics-driven manner, and thus reduce the chances for strong government regulation.

We were repeatedly ignored, or told "we don't need medical informatics here" or equivalent, or patronized (e.g., being told by some corporate bureaucrat out of a Dilbert comic strip that "you don't have enough experience" or the equivalent in buzzword compliant corporate mumbo-jumbo. See example letter below.)

Seeing increasing risks to patients from cavalier, business IT-based approaches to HIT design, development, implementation and lifecycle, I and like minded colleagues are now using our talents to bolster the case for more robust government regulation of HIT. We feel it's well past the point of helping this industry, and protecting patients, from within.

If I were an HIT vendor used to generous accommodation of sloppy products and lack of regulatory oversight, I'd be re-examining my assumptions about the HIT business.

-- SS