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Advocacy at a Glance

October 24, 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.

  • FDA Approves 34 NME Drugs So Far in 2014.  According to an analysis by FDA Webview, CDER eclipsed last year’s 27 new molecular entity (NME) drug product approvals by approving 34 applications through October 15. They note that: “Approval numbers have been bolstered by seven NME approvals over the past 30 days, and the current approval pace could see CDER surpassing the 39 NMEs approved in 2012. Over the past 10 years, annual NME approvals have averaged 26, according to FDA officials.”
  • FDA Cracks Down on Fake Ebola Cures. Virtually every day, an e-mail appears in most of our in-boxes touting cures for various worrisome diseases. While the claims may be bogus, there are clearly consumers who believe them and purchase products that are unproven to be of help. Not surprisingly then, the Ebola public health situation has led to an upswing in promotion of alleged cures. FDA has been vigorously warning companies to stop, as indicated in this report on the NPR “Shots” blog site, so far with success.
  • Early Speculation on New House Appropriations Chairs for Next Congress. With election day less than 2 weeks away, we are seeing the first wave of analysis of who will be in leadership positions on various Congressional committees in the new Congress. This week, CQ NEWS took an early look at the House Appropriations Committee and reflected the uncertainty on the Republican side. Chairman Harold Rogers is expected to continue as committee chairman, but three subcommittee chairs won’t be returning next year: Jack Kingston, Tom Latham, and Frank Wolf. At a minimum, that leaves three subcommittees available (Labor-HHS, Transportation-HUD, and Commerce-Justice-Science) and may set off a cascade as more senior members may choose new panels. The article speculates that the Agriculture appropriations subcommittee chair, Robert Aderholt, might prefer Commerce-Justice-Science, where he is already the vice-chair. There is no indication at this point whether that’s true. The earliest this would be resolved is December.
  • More Regulatory Science Advances: Rare Diseases.  In the FDAVoice blog, Dr. Woodcock highlighted the agency’s work with the National Organization for Rare Disorders (NORD) and other patient groups to gather more/better data on natural history studies diseases. The goal is to help scientists and FDA better understand the thousands of rare diseases that currently have no FDA-approved therapy. While the words “regulatory science” don’t appear in her column, this is yet another advance in the tools that FDA has available to carry out its public health and regulatory functions for the benefit of the American people (and the world).

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