FDA device chief leaves, changes seen

U.S. FDA device chief leaves, changes seen

* FDA's Schultz resigns after meeting with commissioner

* Device unit had been hit by safety, other concerns

* Analyst sees tighter device regulations ahead


By Susan Heavey

WASHINGTON, Aug 11 (Reuters) - The head of the U.S. Food and Drug Administration's device center stepped down on Tuesday, a move that follows a raft of safety and other scandals and could signal tighter industry regulations.

Daniel Schultz, who served at the agency's Center for Devices and Radiological Health (CDRH) for 15 years, resigned after reaching an agreement with FDA Commissioner Margaret Hamburg "that my stepping down at this time would be in the best interest of the center and the agency."

His departure follows a string of problems at the center, such as recalls of various products including those made by top device makers Medtronic Inc (MDT.N) and Boston Scientific Corp (BSX.N). Agency scientists have also complained about pressure from top managers at the device center.

Hamburg, who was appointed by President Barack Obama and began work in May, said the center had "increased the agency's safety efforts" under Schultz's leadership.

But some consumer advocates and other critics hailed his resignation as a way to boost standards and improve consumer confidence in FDA-approved devices, which range from implantable knees and heart defibrillators to contact lenses and tongue depressors.

Schultz led the device center for the last five years, during which major product recalls were initiated over heart defibrillators, coronary artery stents and contact lens solution, among other products.

"This change is long overdue ... There are too many devices on the market that are not proven safe and not proven effective," National Research Center for Women & Families President Diana Zuckerman told Reuters.

Earlier this year, the watchdog group Project On Government Oversight called for an investigation into what it said were too few laboratory inspections of high-risk medical devices.

The move followed a cry from FDA scientists in January that earlier complaints to U.S. lawmakers over a lack of inspections sparked retribution from FDA managers. Congressional investigators earlier this year also said the FDA's approval process for riskier devices was incomplete.

Lawmakers also have expressed concern about the agency's ability to monitor the growing number of advertisements aimed at consumers.

The leadership change could point to larger overhaul at the agency, which is struggling to present a stronger front after years of drug safety issues and food recalls. Zuckerman and others have called for the heads of the FDA's drug and other centers to also be replaced.

As for devices, "they've been embarrassed ... whether there's truth behind it or not, there certainly is the perception that some things happened on his watch that were negative: the recalls, the whispers about top-down pressure to be positive on certain devices," Morningstar analyst Debbie Wang told Reuters.

The move likely means the approval process "will be tightened. You're going to have reach a higher bar in order to get approval," which will lead to more costly clinical trials and more time before a product can go to market.

She added that Hamburg is likely to make Schultz's replacement someone who will appear independent of the industry with a focus on safety.

In a separate letter to FDA staff, Hamburg said she had appointed Jeff Shuren, the agency's current associate commissioner for policy and planning, to lead the device center on an acting basis.

Industry representatives praised Schultz's tenure.

Advanced Medical Technology Association, in a statement, supported his work to continue a program providing device center funding through company-imposed fees, as well as improving the FDA's collection of information about devices after they hit the market. (Reporting by Susan Heavey; additional reporting by Sue Kelly in Chicago; editing by Carol Bishopric and Andre Grenon)





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Good catch on that article, BB. It will be interesting to see what, if any, changes we notice, especially in regards to responses to MAUDE reports.

HALLELUJAH





This post has been edited by dennis100 on Aug 12 2009, 11:21 PM

Schultz approved VNS for depression against the recommendation of the FDA panel

Hee-hee-hee I thought he was the one. Thanks Mr. B. Things might just get a bit interesting from here on out.

:D

AMEN AMEN HALLELUJAH that Schultz is finally outta there!

Thanks for posting the article BB, and also thanks to Mr. B for clarifying to those who didn't realize Schultz' involvement with VNS. What a shame the article didn't mention what he pulled regarding Cyberonics.

It's a good day to know that what comes around goes around, and I personally am quite anxious to see what happens next with the approval process, marketing, sanctions, and MAUDE reports regarding medical devices.

Although some may not see it this way, IMHO justice is finally beginning.

B)

It might have been perfect timing for my detailed MAUDE. Maybe the FDA will start paying attention to those reports now.

I hope for everyone who has either been injured, had sick affects, etc gets some relief from this change in the upper tier at FDA. I don't think they will "unapprove" VNS but am sure they will be looking into this decision.It will be a true blessing if the Maude reports are finally gone through with tooth and comb, for they have been ignored and/or not taken seriously for way too long and have affected way too many people. The deaths of VNS patients really need to closely scrutenized (sp?) because "unknown" or SUDEP is a cop out!

This post has been edited by gel61820 on Aug 14 2009, 02:05 PM

:Yeah That: and Amen Gel and Dennis!

FYI for those who didn't know-the Senate Finance Commitee has been looking into the FDA & Schultz for ignoring his colleagues requests for more testing regarding safety & efficacy issues of VNS for TRD, and approved the use of the device. This began way before the election of President Obama. The head of the Senate Finance Comittee, Senator Chuck Grassley of Iowa, is very involved in the inquiry.

B)