FDA wants more money from entities they supervise
For fiscal year 2010, the FDA requests a total budget of $3.2 billion – that represents a 19 percent increase over 2009 – the largest increase ever in FDA history.br /br /The FDA budget proposes $828 million in industry user fees, an increase of $215 million compared to FY 2009, including $141 million in proposed new user fees. These FDA user fee programs “facilitate premarket review for human and animal drugs and human devices. Three other user fee programs support the mammography facilities inspection program and provide certification services for color additives and for drug and device products exported from the United States.br /br /”In addition to amounts for food safety and generic drug review user fees, the budget includes fee increases for safety and application review for human drugs (+$67.5 million), animal drugs (+$2.3 million), and medical devices (+$4.5 million).”br /br /The acting head of the U.S. Food and Drug Administration, Joshua Sharfstein, defended the agency’s request for more funding from drug companies: “I understand the concern that people … have expressed that user fees create a perception or a conflict of the agency’s work. I think these concerns reflect a broader lack of trust in the FDA.”br /br /strongDr. Grout’s Comment:/strongbr /br /The FDA established a practice of collecting “user fees” from drug companies, food manufacturers, and others the agency regulates. The idea was that the FDA should be able to collect fees from pharmaceutical companies, for example, in order to conduct drug approvals. That may have sounded good to those balancing budgets, but the practice invites conflicts of interest. br /br /Critics say the program ties the interests of FDA’s drug approval office too closely to those whom they regulate, and that the agency has become dependent for its funding upon the very industries over which it has regulatory authority. Due to the dependence on user fees, those being regulated are increasingly seen as stakeholders, customers, or even clients.br /br /The American Association of Health Freedom believes it is time to “reform the Food and Drug Administration from the ground up” and is circulating a petition at a href=”http://www.ReformFDA.org/”ReformFDA.org/a.div class=”blogger-post-footer”img width=’1′ height=’1′ src=’https://blogger.googleusercontent.com/tracker/4769404502414351890-7856213827314109148?l=arizonaadvancedmedicine.blogspot.com’ alt=” //div
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