The Food and Drug Administration is laying out plans to improve its public communications on food and drug safety, more than three years after federal advisers recommended major changes.
The agency said it will begin studying public response to its announcements on potentially dangerous food and drugs. The plan posted online this week takes its cue from a 2006 report by the Institute of Medicine, which found the FDA needed to do a better job communicating with the public. The nonprofit institute advises the federal government on medical issues.
Problems with the FDA’s communications strategy were highlighted when the popular painkiller Vioxx was pulled from the market in 2004, five years after its approval, because of links to heart attack and stroke. The agency was criticized for not alerting the public earlier to those risks.
While most patients understand the benefits of their medications, they know much less about the risks, said Bill Pierce, former spokesman for the Department of Health and Human Services.
“I think this is just the latest step in a long-standing challenge for FDA which is: how do you communicate with public about the drugs they take?” said Pierce, now a consultant with APCO Worldwide, a public relations firm.
The communication plan, begun during the George W. Bush administration, also offers Obama appointees a chance to renew the agency’s image, following a string of bungled drug and food safety recalls in recent years.
“The FDA must communicate frequently and clearly about risks and benefits and inform patients and consumers about ways to minimize risk as they become increasingly involved in managing their health,” FDA Commissioner Margaret Hamburg said in a statement.
Agency officials said it will take five years to implement the overhaul, which also will include communication plans for crisis scenarios and using more video and Web-based materials to educate the public on safe food practices.
The FDA already started notifying the public earlier about drug safety issues. Under its so-called early communication program, the agency issues announcements when it begins looking at potential side effect with a drug, even if no direct link has been established.
Since its introduction in 2007, the policy has highlighted issues with several blockbuster medications, including Merck’s asthma drug Singulair, Pfizer’s smoking-cessation pill Chantix and GlaxoSmithKline’s weight loss pill alli.
The agency ultimately added a “black box” warning to Chantix and bolstered language about suicidal behavior, depression and anxiety on Singulair. Glaxo’s alli is still under review.
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