Healthy Skepticism Library item: 16227

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Publication type: news

Heavey S
U.S. FDA device chief leaves, changes seen
Reuters 2009 Aug 11
http://www.reuters.com/article/rbssHealthcareNews/idUSN1154141520090811?sp=true

Abstract:

• FDA’s Schultz resigns after meeting with commissioner

• Device unit had been hit by safety, other concerns

• Analyst sees tighter device regulations ahead

(Adds reaction, background on devices, byline)

Full text:

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.