OSHA backs down on work noise standard, FDA backs down on medical-device regulation (WSJ)

[somone]

http://online.wsj.com/article/SB10001424052748703951704576092051613167570.html

JANUARY 20, 2011
U.S. Backs Down on Work Noise, Medical Devices
By ALICIA MUNDY, MELANIE TROTTMAN And JON KAMP

A day after President Barack Obama ordered the government to get rid of burdensome rules, two federal agencies backed down from proposals that had drawn jeers from businesses.

The Labor Department said it was withdrawing a proposal on noise in the workplace that could have forced manufacturers to install noise-reducing equipment. And the Food and Drug Administration retreated from plans to tighten rules on medical-device approvals, postponing a proposal that would have given the FDA power to order additional postmarket studies of devices. Industry leaders praised the moves, while consumer advocates expressed disappointment. Diana Zuckerman, president of an advocacy group that had called for tighter medical-device regulation, said, "The FDA has backed down on important safety measures that would have saved lives. FDA decisions should not be based on a popularity contest, especially since lobbyists rig the results."...

The FDA's announcement was previewed by President Obama in a Wall Street Journal opinion article Tuesday that said the medical-device changes would result in "getting innovative and life-saving products to market faster." That signaled a win to device makers. "It became obvious that industry would hear good news" with the publication of a presidential op-ed "urging smarter regulation," said device-industry lawyer Jeffrey Shapiro of Hyman Phelps & McNamara PC...

On the noise issue, the Labor Department's Occupational Safety and Health Administration said it was responding in part to concerns raised by manufacturers and others... With the backing of labor groups such as the AFL-CIO, the agency had proposed a reinterpretation of standards that would have raised the bar. Some manufacturers said they might have been forced to install costly noise-reducing equipment. An agency spokesman said OSHA believes the proposed interpretation wouldn't have imposed overly burdensome costs on businesses. Since 2004, nearly 125,000 workers have suffered significant, permanent hearing loss... The AFL-CIO's director of health and safety, Peg Seminario, said the impetus for the Labor Department's move and Mr. Obama's order was the same. "You've got the business community yelling fire," she said. "At this point the Obama administration seems to be giving greater consideration to the claims of business."

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