Healthy Skepticism Library item: 12636

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Publication type: news

Cohen R.
FDA's health dire, experts say: Setbacks highlight an agency in crisis
The Star Ledger 2008 Jan 30
http://www.nj.com/business/ledger/index.ssf?/base/business-8/1201671376279680.xml&coll=1

Full text:

The Food and Drug Administration’s ability to protect the public from unsafe drugs, medical devices, foods and other products has radically deteriorated, placing Americans in jeopardy, expert witnesses told a congressional committee yesterday.

“It is readily apparent that the FDA suffers from serious scientific deficiencies and is not able to meet its current or emerging regulatory responsibilities,” said Gail Cassell, an Eli Lilly vice president and head of an internal FDA scientific advisory board that studied problems at the agency.

“We have concluded that American lives are at risk,” Cassell told the House Energy and Commerce investigations subcommittee. “Without urgent action, injury and death are certain.”

Garret FitzGerald, a professor at the University of Pennsylvania School of Medicine and member of the science board, said the problems are systemic and include depleted infrastructure; critical gaps in science expertise; erosion of financial resources; inadequate information technology; poor morale; and an inability to enforce its own rules.

“The FDA is in crisis. The ability of the agency to fulfill its mandate has eroded to a critical degree,” FitzGerald said.

He said the withdrawal of the painkiller Vioxx, the controversy over the safety of the diabetes drug Avandia, recent questions about the effectiveness of the cholesterol medicine Vytorin and recalls of pet food, toothpaste and other products from abroad “have undermined our belief that the agency can safeguard the public.”

“These are warning signs of a gathering storm. We ignore them at our peril,” FitzGerald said.

The science board made it findings public last November, urging a major restructuring of the agency, a doubling of its budget from about $2 billion to $4 billion in two years, and a 50 percent increase in the number of employees.

Yesterday, FDA Commissioner Andrew von Eschenbach, who commissioned the study, acknowledged the agency needs more resources, but declined to say how much. He testified the FDA is working on plans to improve and strengthen its operations.

“We recognize the world has radically changed around us and we recognize we have to change and adopt,” von Eschenbach said.

The commissioner said he takes the science board report “very seriously,” but insisted the FDA still represents the “gold standard” of drug and device regulation, and said its science capabilities, while needing improvement, are “strong.”

Peter Barton Hutt, a science board member and former general counsel at the FDA, told the congressional panel that 100 laws giving the FDA new responsibilities have been passed in the last 20 years, while agency resources have not kept pace. He said it is up to Congress to help solve the problems.

“Telling the FDA to do more with less is impossible,” Hutt said. “The agency is barely hanging on by its fingertips.”

The bleak picture painted by the science board members was brought into specific focus by a Government Accountability Office report on medical device regulation.

The GAO said yesterday U.S. companies that make high-risk devices, such as pacemakers and heart valves, are supposed to be inspected every two years, but in fact are being visited for safety once every three years. The GAO said companies overseas that make the same type of devices for sale in the United States are inspected only once every six years because of lack of personnel.