Regulatory Focus™ > News Articles > Report: Clashes Between White House, FDA Frequent

Report: Clashes Between White House, FDA Frequent

Posted 03 April 2012 | By Alexander Gaffney, RAC 

A report in The New York Times indicates the US Food and Drug Administration (FDA) and the Obama Administration are frequently at odds-partially the result of poor communication and partially the result of poor political optics-which has caused significant amounts of tension between the two government bodies.

The report notes numerous instances where the Administration and FDA have clashed, including the banning of Primatene asthma inhalers, Health and Human Services Secretary Kathleen Sebelius overruling FDA's approval of Plan B for those under the age of 17, the approval of KV Pharmaceutical's 17P and subsequent price increase, calorie counts on movie popcorn and efficacy claims on sunscreen.

The White House is keenly aware of election-year politics tainting any regulatory actions, writes The Times. "Republicans have made the charge that Mr. Obama is an overzealous and job-killing regulator - a central element of their case against his re-election. And on issues from clean air to investor protections, the White House has been carefully calibrating its election season positions."

More than the policies themselves, notes The Times, is the lack of warning given to the White House about minor-and even major-announcements FDA makes. The lack of communication has often led to "sharp rebukes," reports The Times.

The White House's attempts at interference have some critics concerned about a scientific agency slowly turning into a political one.

"In a globalizing world, where trust is a huge part of what American manufacturers have to sell, the politicization of FDA could hurt not only consumer protection but industry profits as well," said Daniel Carpenter, an FDA historian at Harvard University. 

This could also hurt regulatory harmonization efforts abroad, explained Carpenter. "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.' "

Unnamed officials at the White House, meanwhile, stated they thought agency naiveté was partially to blame for the tensions. "They want a world that doesn't exist anymore," an administration official said to The Times.

Another unnamed official at the Centers for Disease Control and Prevention countered that notion, telling The Times the amount of work it would take to communicate every single action to the White House would be unrealistic.  "[In] the end, it can't really be done," the official said.

In a statement, FDA Commissioner Dr. Hamburg said FDA "will continue to work with our colleagues at the White House and across government to protect and promote the health of all Americans," but refused to go into details about The Times' report.

Read more:

The New York Times - White House and the FDA Often at Odds

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