FDA Asks Consumers To Submit Questions As Part Of Transparency Plan

Mar. 17--So how and when does the Food and Drug Administration decide to pull a prescription from the market?

Should I be asking whether my doctor accepts gifts or sandwiches from drug companies? Why are drug makers notified by the FDA when a device is harmful before the general public?

Questions like these from consumers can be posed to the FDA as part of an effort to make the agency more open and less arcane to the general public, as well as the health care providers and companies it regulates, the agency said.

The agency is seeking public comment on how it can increase transparency with the industry it regulates. The FDA said it formed the "Transparency Task Force" in response to the Obama administration’s overarching effort to "achieve an unprecedented level of openness in government."

The FDA has come under increasing criticism over the lack of transparency in its oversight of drugs, most notably the arthritis pain pill Vioxx. The drug was on the market for several years before a study showed it was linked to an increased risk of stroke and heart attack, forcing Merck & Co. in 2004 to withdraw the product used by millions of Americans.

"The task force is developing recommendations for making information about FDA activities and decisions more useful, understandable and readily available, while appropriately protecting confidential information," the agency said in a statement.

To submit comments online, go to regulations.gov. For more information about the FDA’s transparency initiative, go to www.fda.gov/transparency.

Hear Bruce Japsen on WGN-AM 720 at 12:49 p.m. and 11:15 p.m. Mondays and 7:35 a.m. Sundays. See previous health care notebooks at chicagotribune.com/healthcare.

bjapsen@tribune.com

To see more of the Chicago Tribune, or to subscribe to the newspaper, go to http://www.chicagotribune.com.

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Posted: March 2010


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