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Advocacy at a Glance

July 11, 2014

Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.

  • FDASIA: Just 2 Years Ago. The second anniversary of the  Food and Drug Administration Safety and Innovation Act has provided an opportunity for FDA, Congress and stakeholders to look at what has been accomplished. Commissioner Margaret Hamburg provided the agency’s views in a blog column highlighting advances in: preventing drug shortages; promoting innovation; establishing and strengthening user fee programs; and enhancing patient engagement. Deputy Commissioner Howard Sklamberg provides additional perspectives in a blog column on protecting the global drug supply.
  • FDA Issues Nanotechnology Guidances. To be effective, FDA must stay on top of a vast array of new science. One with potential to transform our society and our economy is the growing field of nanotechnology. This week, FDA released guidance documents on how to determine whether products contain nanotechnology and on applicability of this technology to food, cosmetics, and animal feed. Eventually, all the Centers will find themselves involved in regulating products that incorporate nanotechnology.
  • Congress Returns for 4-Week Session Between July 4th and August Recesses. An increasing number of articles have popped up talking about how few legislative days are left before Congress is scheduled to adjourn. Both House and Senate returned after July 4th and have 3 more weeks left before the August 1 start of the summer recess.
  • Prospects for a Continuing Resolution. The breakdown of the appropriations process, combined with the short remaining legislative calendar, has led to the probability that much of the government will start the new fiscal year (October 1) on a continuing resolution. This week’s Analysis and Commentary looks at how and why the process has broken down. In future weeks, we are likely to devote considerable space to the implications and impact on FDA if a continuing resolution becomes necessary.
  • A Great Question from Dr. McClellan. Today at an American Enterprise Institute event focusing on medical cures, former FDA Commissioner Dr. Mark McClellan interviewed Dr. Michael Burgess (R, TX), a lead member of the House Energy and Commerce Committee. As part of the discussion, Dr. McClellan focused several questions on whether the agency has sufficient resources to accomplish the tasks asked of it from Congress. While Dr. Burgess was circumspect in his answers because he is an authorizer and not an appropriator, we appreciate Dr. McClellan keeping the issue on the front burner at this public forum.

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