Building a National Framework for the Establishment of Regulatory Science for Drug Development Workshop Summary (2011) / Chapter Skim
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6 Challenges in Engaging the Public Policy Community
6 Challenges in Engaging the Public Policy Community
Pages 39-44
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From page 39... ...
It's $25 million, and in the HHS budget, sometimes $25 million seems small. But it is a great beginning." Hamburg agreed with the importance of expanding regula tory science to open up possibilities for new diagnostics and safer and more effective treatments: "It's essential," she said, "that we have a regu latory agency that is scientifically robust and trusted by policy makers and the American people." Proper support for scientific capacity and sustainable resources can provide the autonomy FDA needs to pursue its mission free of the influence of political tides or funding mandates, said Hamburg.
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CHALLENgES IN ENgAgINg THE PuBLIC POLICy COMMuNITy Steven Grossman, founder of Alliance for a Stronger FDA, highlighted three principal challenges that hinder engagement of the public policy community in support for enhanced regulatory science at FDA: funding, policy development, and communication. • unding -- Fully 80 percent of FDA's budget goes to personnel F costs.
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A subsequent survey question in the same series showed respondents were evenly divided when Opinions on America's Most Important Health Issue What would you say is the single most important health issue people in the United States today? (first volunteered responses)
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Protecting the safety of the American 59% 24% 10% public Providing accurate information to the 1st 17% 39% 29% 15% American public about the benefits 2nd and risks associated with medicines 3rd Getting new medicines and medical 4th 16% 16% 26% 42% products to the American public Regulating companies that produce 36% 22% 35% medicines and medical products FIguRE 6-3 Americans' views on FDA's most important role. SOURCE: National Public Opinion Polls, 2003−2010, Charlton Research Company for Research!
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THE POWER OF PATIENT ADvOCACy Perhaps the most effective way to reach policy makers is through those they are supposed to represent: the public and patients. Newly tested positive for HIV in the mid-1980s, Michael Manganiello, Partner, HCM Strategists, and a patient advocate, recalled his initial layperson's view of FDA: "I knew about as much about FDA as I did about quantum physics, which was nothing, except I quickly became aware that FDA was the place that was standing in the way of me getting better drugs." Manganiello said he revised his opinion after learning that many more barriers stood in his way: lack of political will, lack of resources, and lack of support from the American people.
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From page 44... ...
In going forward, Sigal observed that OOPD could further advance regulatory science by enhancing collaboration among the different FDA centers, increasing interactions with other health-related federal agencies, expanding external advi sory capacity, and harmonizing with international regulatory bodies. SOURCE: Sigal, 2009.
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