Regulatory Focus™ > News Articles > House PDUFA Draft: Make FDA's Review Process Take Into Account Job Creation

House PDUFA Draft: Make FDA's Review Process Take Into Account Job Creation

Posted 20 April 2012 | By Alexander Gaffney, RAC 

Draft legislation to reauthorize a number of bills funding the US Food and Drug Administration (FDA) through user fees includes a provision to add economic considerations to the agency's mission, reports Med Page Today.

The provision, put forth by Congressman Mike Rogers (R-MI), would mandate FDA take into account the promotion of economic growth and job creation in addition to its standing mandates to promote public health by ensuring medical products are safe and effective.

The measure received swift and negative feedback from FDA's Director of the Center for Devices and Radiological Health, Jeffery Shuren.

"Jobs where? Jobs for who?" asked Shuren during a House Energy & Commerce Health Subcommittee hearing. "Is that really a condition of when a device comes to market?"

"Let's focus on getting safe and effective devices to patients in a timely manner," Shuren told MedPage Today after the hearing. "That protects patients."

"Besides altering the very nature of the FDA's mission, such requirements would vastly expand its duties and add to the burdens of an already massively overburdened agency," wrote CNN Money.

Shuren explained FDA would likely have to employ a team of economists to gauge a device's potential economic impact, and would face potential lawsuits from rival competitors if a device's approval failed to create jobs, reports Med Page Today.


Read more:

Med Page Today - Lawmaker Wants Change in FDA Mission

CNN - Congressman would revamp FDA's mission to 'protect jobs'

Mass Device - FDA: Safety, efficacy, public health - and economy?


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