February 2013

Sequester Cuts Loom Large at FDA

Just before the January 1 deadline, Congress passed the American Taxpayer Relief Act (ATRA) that delayed deep, mandatory, cuts to federal discretionary spending for two more months. Congress now has until March 1 to enact an alternative deficit reduction plan or the Administration will be forced to cut almost $85 billion from across the Federal Government.

Should sequestration take effect in March, FDA could face up to $319 million in cuts, including the potential loss of the recently negotiated user fee agreements within the FDA Safety and Innovation Act (FDASIA). While many federal agencies are facing similarly harsh cuts, FDA Commissioner Margaret Hamburg points out that the FDA has an unfortunate burden of achieving those savings largely from cuts to agency personnel, infrastructure, and operations. She stated last week that the agency “will find every way to protect against the damage,” but that it doesn’t “have a lot of fat in the system as a starting point” to bore the brunt of the cuts. It has been estimated that for every $1 million less FDA is budgeted, four to five jobs are lost, making sequestration potentially responsible for the permanent loss of 1000 to 2000 jobs; jobs that keep America’s food and drugs safe, and ensuring timely access to breakthrough treatments. To reduce spending, the agency has already undertaken a number of measures including using less building space and encouraging telework.

Hamburg said at a meeting of the Alliance for a Stronger FDA, that the agency will attempt to move forward with implementation of new programs, but such large cuts would force the agency’s modernization efforts into a “stall mode.” She added that FDA would be forced to reduce operational support for meeting newly agreed upon review performance goals, and three innovative new laws concerning food safety, drug and device safety, and efficacy and biosimilars, slowing their implementation and forcing many of the processes to be halted all together.

Such a set-back at the agency not only directly affects its core mission, to protect and promote the health of the American people, but stifles much-needed innovation and sets therapy development for costly and debilitating conditions back for years to come.

For more on Commissioner Hamburg’s comments, click here and here.

Series Features ACT-AD Meeting on Combination Therapies

On November 29, ACT-AD hosted the fifth in a series of working meetings with senior representatives from the U.S. Food and Drug Administration (FDA), leading scientists, drug developers, and Alzheimer’s advocates to address critical issues affecting the development and review of new Alzheimer’s disease therapies. The presentations, panels, and open dialog during the meeting focused on how to foster more robust pre-competitive collaboration in Alzheimer’s disease in order to encourage the development of combination therapies and bring new treatments to market. The meeting explored the challenges of these collaboration and potential opportunities for future partnership. Individuals involved in current and past collaborative efforts, reflected upon their experiences and prescriptions for the field moving forward.

The meeting was featured in a February 15, 3-part series in the Alzheimer’s Research Forum laying the foundation for a follow up session to be held later this year. The series can be accessed below.

Part 1: Time to Open a New Front in AD?
Part 2: FDA Puts Flesh on Bones of Draft Guidance
Part 3: Companies Can Play Well in One Sandbox

ACT-AD Chair Quoted by BioCentury on FDA Retirement and AD Guidance

On February 11, Steve Usdin, Washington Editor of BioCentury, published an article in BioCentury The Bernstein Report on Business focused on the future of the FDA’s Division of Neurology Products following the expected retirement later this year of the current Division Director, Russell Katz, M.D. Representatives from the biopharmaceutical industry and the patient advocacy community were interviewed for this article, including Daniel Perry, President & CEO of the Alliance for Aging research and Chair of the ACT-AD Coalition. Dan highlighted ACT-AD’s positive relationship with Dr. Katz and expressed hope that Dr. Katz’s successor will approach the review of therapies for Alzheimer’s disease with similar openness and flexibility.

Prior to the publication of this story, FDA released long-awaited draft guidance on the development of treatments for early stages of Alzheimer’s disease. Elements of a prepared statement were also included in Usdin’s BioCentury article.

To read “Following Katz at FDA,” click here.
To view the FDA Guidance, click here.
The Alliance’s statement on FDA’s draft guidance can be found, here.