Originally Published MDDI December 2001
NEWS & ANALYSIS
In October, AdvaMed announced the formation of an industry council that would help develop strategies "to ensure that America is prepared to respond to future acts of terrorism or other civilian disasters" (see November 2001 issue of Medical Device & Diagnostic Industry). Last month, the organization named six senior executives of medical technology companies to serve as the directors of the Medical Technology Preparedness Council.
The directors will include Richard A. Gonzalez, executive vice president, Medical Products, of Abbott Laboratories (Abbott Park, IL); Ronald K. Labrum, group president of Allegiance Corp. (McGaw Park, IL); Dennis N. Longstreet, group chairman of Johnson & Johnson (New Brunswick, NJ); Edward J. Ludwig, president and CEO of Becton Dickinson and Co. (Franklin Lakes, NJ); and Richard J. Meelia, president and CEO of Tyco Healthcare Group (Mansfield, MA). The council will be chaired by William H. Longfield, chairman and CEO of C.R. Bard Inc. (Murray Hill, NJ) and chairman of AdvaMed's current board of directors.
|Susan Alpert has been selected as the medical adviser to AdvaMed's Medical Technology Preparedness Council.|
AdvaMed also announced that former Office of Device Evaluation (ODE) Director Susan Alpert, PhD, MD, will serve as medical adviser to the council. Alpert, who became vice president of regulatory sciences at C.R. Bard after leaving ODE, says, "Medical technologies, such as rapid diagnostic tests. . . , are perfect examples of how makers of medical devices and diagnostics can help combat bioterrorism." The group notes that Alpert will be able to offer the council "dual perspectives of a physician and government official when tackling issues to improve the readiness of the nation's public health system."
The council's actions are being shaped in part by the findings of AdvaMed's recent survey of medical technology company executives. Respondents to the survey identified three areas of critical technology development, including diagnostic devices for biological and chemical agents, vaccine-delivery devices, and blood safety technologies. The council specifically "will work to accelerate the development and expedite FDA review of needed medical technologies to combat bioterrorism," according to AdvaMed.
AdvaMed submitted testimony on behalf of the council during a House Energy and Commerce Subcommittee on Oversight and Investigations hearing on November 1. The testimony outlined steps that the council believes will help speed availability of key technologies.
The council will call for a collaborative expedited review policy for medical technology. This will entail the need for clear FDA review paths, the group argues, citing combination products as a technology that faces added delays at FDA because such products must go through two FDA offices for premarket review. The council will urge FDA to establish "a separate office to ensure clear review paths and timely action on these technologies," according to AdvaMed.
A second key issue to be addressed by the council is the need for scientific expertise at the agency when dealing with the complex scientific issues that are likely to be presented by breakthrough countermeasures developed to fight bioterrorism. The council will also argue that FDA should receive adequate resources to ensure timely premarket review of technologies that could help meet needs resulting from terrorist attacks or other civilian disasters. AdvaMed suggests that an additional $1.5 million be made available for priority review and preapproval inspections for breakthrough medical technologies that provide countermeasures to bioterrorism, and that the agency be encouraged to use its existing authority to contract with outside experts.
Copyright ©2001 Medical Device & Diagnostic Industry