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FDA commissioner talks dangerous drugs, innovation and regulations at Public Citizen

FDA commissioner Margaret Hamburg speaks with Public Citizen president Robert Weissman

FDA commissioner Margaret Hamburg has a lot on her plate, especially considering the wide array of issues her agency covers. Luckily, she was able to chisel some time out of her busy schedule to fit in a discussion at Public Citizen.

She spoke today about a number of these topics, but divulged that she is concerned about two concepts: that the FDA is seen as a bureaucratic agency impeding innovation, and the role and influence Congress is exerting in the FDA’s budgetary process.

Hamburg said that she recognizes the importance of innovation, but that in reality, the U.S. is approving more drugs and medical devices than the agency’s counterparts in Europe. When it comes to moderate- to low-risk devices, the U.S. is out in front, she said. And the FDA is usually the first to approve a drug for unmet human needs, she added.

In terms of the budget, Hamburg said she was thrilled that the FDA was one of the few governmental agencies that saw an increase in its 2011 budget. But when the budget for 2012 rolled around, she saw many red flags, including amendments prohibiting resources from being used to research RU-486 (which opponents call the “abortion pill”) or genetically engineered salmon. These amendments come with concerning implications, she said, and the restrictions would limit the agency’s ability to build upon regulations that protect the American people.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, chimed in that while the FDA was once considered the gold standard, the agency has lapsed in its effectiveness by allowing dangerous drugs to be on the market. In our 40-year history, Public Citizen has asked the FDA to ban 35 drugs, two-thirds of which have since been removed from the market.

But a few notable examples from recent years, Dr. Wolfe finds concerning. In the amount of time between when European agencies banned the pain medication Darvon and when the U.S. caught up, 120 million prescriptions were filled and 1,000 to 2,000 people were killed. Between when Europe banned the diet pill Meridia and the U.S. followed suit, 160,000 prescriptions were filled and there were a number of deaths. And the FDA has yet to ban the dangerous diabetes drug, Avandia, of which half a million prescriptions are filled. Public Citizen has petitioned the FDA to remove all three of these drugs from the market.

To learn more about the discussion today, see the live-tweeting done by Angela Bradbery (@citizenangela), Public Citizen’s communications director, below (in descending order):

  • Its an area we need 2 continue to work on, need to be transparent, hamburg says. #fda
  • Q on conflict of int by reviewers, hamburg says its important 2 have unbiased review. #fda
  • Hamburg: re question re globalization, yes it has nat’l security implications. we need to be realistic re growing demands on #fda
  • Hamburg on reorg: designed to streamline and better organize the #fda no extra layers were created
  • Hamburg: it’s hard b’c of lack of resources. We need 2 work more with other countries’ regulators. #fda need to boost indstry accountability
  • Q: why higher turnover in device division? A: people r stretched thin, hamburg says #fda
  • Hamburg: a lot of device applications r by first timers so lack all components. #ffda
  • It is in the device program we have highest turnover, hamburg says. We need more expertise 4 device review. #Fda
  • Hamburg: we need to systematize our thinking abt balancing risks and benefits #fda
  • Hamburg: “we have a ways to go” am trying to strengthen office, bring in more expertise. #fda
  • Q: @Public_Citizen‘s @SidneyWolfeMD: how quickly does #fda act on dangerous drugs? Lists drugs we petitioned to have banned. Fda dragged ft
  • On dtc ads, hamburg says review of ads is challenging. A good time to look at how we do dtc ads. #fda how can we use them to address broad
  • Q: has globalization spun beyond control of regulators? A: not going to stop it. We need more of a global alliance of regulators.
  • Hamburg: these amendments could hinder our ability to look at important therapies.#fda
  • Hamburg: #fda budget was better in 2011. But amendments to current budget are concerning, such as limitation on ru486 work
  • Hamburg: it is a misconception that drug review takes longer here than in europe. #fda is faster.
  • Hamburg on claims that #fda hampers innovation and drives up costs: a complex discussion.
  • Hamburg: if we can help develop reg system in other countries we can ensure safer supply chain. #fda is working on this.
  • Hamburg on globalization: new world. #fda is responsible for products coming from 150 countries. 40% of drugs come from other countries.
  • Hamburg: #fda needs to keep up with science of safety so can use all data to apply to work
  • Hamburg: we have to b a science-based, data-driven agency. Fda hasn’t always had enough $ to keep up with science, enough resources.
  • Hamburg: in times when there is suspicion of govt, #fda is vulnerable. Trying to boost transparency.
  • Hamburg trying to ensure #fda focuses on outcomes, prevention, balancing risks and benefits.
  • Hamburg was surprised about the breadth of #fda‘s responsibilities. Food, drugs, sunscreen, tobacco now. “We r unique. We r essential.”
  • Hamburg speaks of many health-related contributions of @Public_Citizen over the past 40 years. #fda
  • Dr. Hamburg: nomination process was a mystery. #fda still can get bipartisan support.
  • Dr wolfe: the fda has been better off with hamburg. #fda
  • Sid wolfe giving intro remarks. He was delighted when hamburg was nominated b’c of her public health background.
  • Hamburg getting miked. About to start.
  • Droid is charging 4 live tweeting of #FDA commissioner Hamburg. Watch here at 12:30 p.m. We are expecting a good crowd of journos, others.

Check out more information about Public Citizen’s work on dangerous drugs.