FDA officials say White House caved to political pressure on certain reforms | MassDevice.com On Call

MassDevice On Call

MASSDEVICE ON CALL — The Obama administration caved in to political pressure on certain measures in attempts to quell controversy as the White House built its case for health care reform, according to a story in the New York Times.

Worried that any political missteps might muddle arguments for reform, the administration delayed important regulations in order to avoid creating an easy target for Republicans.

"This was the era of Glenn Beck, and the White House was terrified that Beck would get up and say this is all part of the nanny state," a senior FDA official told the paper.

Concerns about the administration’s image may have played a role in decisions such as the retracted move to require that movie theaters post calorie counts for their concessions, the squashed move to require manufacturers of low-SPF sunscreens to warn consumers that they do not protect against cancer or skin again, and the precedent-setting decision by Health & Human Services secretary Kathleen Sebelius to prevent over-the counter sales of emergency contraceptives to girls under the age of 17.

"In a globalizing world, where trust is a huge part of what American manufacturers have to sell, the politicization of the FDA could hurt not only consumer protection but industry profits as well," Harvard University historian Daniel Carpenter told the Times. "If this trend continues, one could easily see major government purchasing programs in Europe, India, China and elsewhere saying, ‘We’re not going to follow FDA recommendations anymore.’"

Others viewed President Barack Obama’s politically cautious approach as a departure from the ideals that were laid out in campaign promises.

"To the career people, that was disappointing," an unnamed top FDA official told the paper. "Employees here waited 8 long years for deliverance that didn’t come."

U.K. regulators urge caution on certain metal-on-metal hips

Regulators at the U.K.’s Medicines & Healthcare products agency warned surgeons to avoid certain metal-on-metal hip implants made by Johnson & Johnson (NYSE:JNJ) and Stryker (NYSE:SYK) over concerns that they fail more frequently than other hip replacement devices, Bloomberg Businessweek reported.

U.S. Medicare incentive payments topped $390 million in 2010

U.S. regulators in 2010 paid more than $390 million in incentive payments for Medicare’s physician quality reporting program, Law360.com reported.

Routine mammograms risk significant rates or over-diagnosis

New research suggests that routine mammogram screening may lead to "a significant amount of over-diagnosis of disease that would otherwise have proved harmless," according to Harvard’s School of Public Health.

MIT students launch "make your own" medical device shop

MIT students launched Little Devices, a group focused on using components to hack together cheap medical devices for developing countries, according to a CNN blog.

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