New FDA Commissioner vows to get tougher in the name of safety Print E-mail
By Jamie Tera & Wire Reports   
Wednesday, 17 June 2009 22:08

Newly minted FDA Commissioner Margaret Hamburg says she will toughen up the agency’s enforcement practices. She wants to take the sprawling bureaucracy and remake it into the key federal agency that protects public health.

The agency—responsible to ensure drugs, medical devices and products, some human and animal food products, cosmetics, and other consumer goods are safe to Americans—has been widely faulted for all manner of problems, including that had no permanent commissioner for the majority of former President Bush’s eight-year term.



Under the former administration, the FDA was accused of letting politics minimize science and, it was during that time, that some of the most notorious drug safety and food borne illness outbreaks and recalls originated, such as Medtronic Sprint defibrillator leads, Baxter infusion pumps, faulty heart stents, and squeaky hip replacements. In addition to countless drug and
medical device recalls, there have been issues with toxic ingredients in consumer products, controversies over physician and

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researcher gifting by industry, inappropriate medical devices and medication marketing, and a system rife with corruption.

"It really goes back to what the FDA was about from the very beginning: a very clear public health mission but with a regulatory framework for action," Hamburg said, adding that she wants to increase transparency. "The FDA has been seen as a cold regulatory agency and
also something of a black box," she said. "We have a chance to open it up and make sure the American people have the safe, high-quality foods they need, the safe and high-quality drugs and medical equipment they need."

“We are focusing not on keeping a tally of how many inspections we do or how many drugs we approve but how do we make a difference in people’s lives,” Hamburg said in an interview with The Associated Press.

Food safety is one such area, and “it’s a critical time in the recognition that there is a problem,” she said. “The number of recent outbreaks have underscored for the public and policymakers that things need to change.”

The FDA, the nation’s chief consumer protection agency, has struggled for years to keep up with increasing responsibilities to oversee the nation’s ever-more-complex health industries as well as food, without a budget sufficient to do the job. Its own scientists have charged that their safety concerns were dismissed by leaders too cozy with industry.

Hamburg arrived three weeks ago vowing to restore the FDA’s credibility by focusing on science-based decisions that shore up public health. Tuesday, she put food safety at the top of the list. The FDA has asked Congress for a nearly 20 percent funding increase and new industry user fees to pay for more inspections.

But Hamburg said there are too many food suppliers here and around the world for the FDA to physically inspect every one. Her goal is to focus on the riskiest foods and implement prevention strategies — what scientists call risk-based controls — to target the spots along the farm-to-store chain where contamination can occur.

FDA also needs to use 21st century technology to help speed approval of new drugs, monitor for the earliest signs of side effects once medications hit the market — and take a hard look at the safety of emerging science like nanotechnology that is being used in a broad array of products.

“It’s in cosmetics, drug delivery, things I never would have imagined, like clothing,” Hamburg said. “We need to understand more about that emerging technology and how to evaluate it.”

"The first weeks have been very full," she said. "And my learning curve is extremely steep."




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