Douglas C. Limbach

December 1, 2007

3 Min Read
FDA Advocacy Organizations Join Forces

In mid December, the Coalition for a Stronger FDA and the FDA Alliance announced plans to merge into a single organization known as the Alliance for a Stronger FDA. Both organizations, which emerged as independent entities in 2006, were founded on the notion that FDA does not have the necessary resources to fulfill its mission of protecting the public health. According to the groups, the merger—which will go into effect at the beginning of January—will create a stronger, more multifaceted organization dedicated to securing a higher level of congressional funding for FDA.

 

Grossman

 

Grossman: Stronger together.

“We have each been successful in educating about the need for more appropriated funds for FDA, and now we'll be able to do an even more effective job,” said Steven Grossman, the executive director of the FDA Alliance, who will serve as deputy executive director for government relations and communications in the merged organization.

Industry associations AdvaMed (Washington, DC) and the Medical Device Manufacturers Association (Washington, DC), in addition to several device companies, will be represented among the merged alliance's members.

“The new organization assures that patients and consumers will be heard, while enjoying the clout derived from having a common cause with other FDA stakeholders, including health professional groups, health voluntary agencies, and industry,” said Diane Dorman, vice president for public policy at the National Organization for Rare Disorders, who will serve on the board of the merged organization. “More voices calling for additional federal appropriations for an abandoned agency cannot be ignored.”

Two weeks prior to announcing the merger, the groups issued a joint press release regarding a new report released by a subcommittee of FDA's science board. The report, titled FDA Science and Mission at Risk, concluded that the nation's food supply is at risk, as are the regulatory systems that oversee the nation's drug and device supplies.1 The report, which was presented to and adopted by the FDA science board, cited the following major findings.

  • FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.

  • FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.

  • FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.

The subcommittee attributed the deficiencies to soaring demands on FDA and the fact that the agency's resources have not increased in proportion to those demands—premises on which the Coalition for a Stronger FDA and the FDA Alliance were founded.

Following the merger, Wayne Pines of the FDA Alliance will serve as president of the group, and Ladd Wiley of the Coalition for a Stronger FDA will serve as executive director.

The merged alliance will have 10 honorary cochairs. They are as follows.

  • Three former secretaries of the Department of Health and Human Services: Louis W. Sullivan, Donna E. Shalala, and Tommy G. Thompson.

  • Seven former FDA commissioners: Charles C. Edwards, Donald Kennedy, Arthur Hull Hayes Jr., Frank E. Young, Jane E. Henney, Mark B. McClellan, and Lester M. Crawford.

For more information about the Alliance for a Stronger FDA, look for a commentary by the organization in the January/February 2008 issue of MX magazine (www.devicelink.com/mx). The commentary is part of the article “2008 Medtech Public Policy Watch,” in which 10 leading industry organizations outline their policy agendas for the coming year.

Reference

1. FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology (Rockville, MD: FDA, 2007); available from Internet: www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf.

© 2007 Canon Communications LLC

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