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Advocacy at a Glance

August 2, 2013

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.

  • Sequestration as Government Malpractice: Op Ed. A tip of the hat to former Alliance board member Ellen Sigal of Friends of Cancer Research. Her op-ed on the impact of sequestration on FDA appeared in the July 30 edition of Reuters On-Line. Using the newly-created breakthrough drug program as an example, she notes that: “Because these are by definition revolutionary drugs, the FDA and drugmakers meet more frequently and work together more closely to speed the benefits to patients. But this kind of engagement — directed by Congress — requires increased FDA resources at a time when the sequester is taking money away from an already underfunded agency.”
  • Senate Bill Introduced to Prevent Sequestration of FDA User Fees. Sen. Mark Pryor (D, AR), chairman of the Senate Appropriations Subcommittee on Agriculture/FDA and Sens. Roy Blunt, (R, MO), Daniel Coats (R, IN), Al Franken (D, MN), and Jerry Moran (R, KS) introduced S. 1413 to exempt future Food and Drug Administration (FDA) user fees from sequestration. A similar bill, H.R. 2725, was introduced in the U.S. House of Representatives earlier this month by Representatives Leonard Lance (R, NJ), Anna Eshoo (D, CA), Mike Rogers (R, MI), and Doris Matsui (D, CA).
  • Major Trade Groups Praise Effort. A number of industry groups praised introduction of the Pryor-Blunt legislation. A joint letter went to the Senate bill sponsors from: GPhA, AdvaMed, BIO, PhRMA, and the Medical Imaging & Technology Alliance (MITA).
  • Bipartisan House Coalition Seeking Answers from Treasury on Sequestered FDA User Fees. Authors of House legislation to exempt Food and Drug Administration (FDA) user fees from sequestration have written to the Treasury Department and OMB asking questions about where the funds are being held and how they are being used. Click here to see a copy of the letter.
  • House and Senate Protocols for Handling Appropriations — Big Changes are Underway in Both the House and Senate. These trends are explored in this week’s Analysis and Commentary.
  • Join Us on August 15 to Meet Key Leaders of FDA’s International Programs. The Alliance is pleased that Lou Valdez, head of international programs, Altaf Lal, head of FDA’s India Office, and Chris Hickey, head of FDA’s China Office, will provide a presentation on FDA’s priorities in India and China. Lou and Altaf will join us in person, and we will video stream Chris in from China. Alliance members are invited to join us for what promises to be a very interesting event. The program will start at 9:00 a.m. on August 15, and we will have a short, informal, reception afterwards.

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