Medical Devices & FDA

This isn’t a biotech story, but relevant to those in the biotech industry who manufacture medical devices:
Wall Street Journal: Political Lobbying Drove FDA Process

The recent approval of a new device to treat knee injuries followed a lobbying campaign that overcame repeated rejections by scientists within the Food and Drug Administration, agency documents show.

The FDA’s internal dissent over Menaflex, which targets the most-common knee injury afflicting everyone from high-school athletes to baby boomers, is straining a government agency that oversees a quarter of the U.S. economy. Some senior FDA staff members complained in documents that the handling of Menaflex, made by ReGen Biologics Inc., shows how political and industry pressure can influence scientific conclusions.

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About Chris MacDonald

I'm a philosopher who teaches at Ryerson University's Ted Rogers School of Management in Toronto, Canada. Most of my scholarly research is on business ethics and healthcare ethics.
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