That’s the message FDA officials want to send amid a barrage of criticism over a number of issues, particularly drug safety. And so in carefully calibrated remarks last week, they contrast the recent number of public-health advisories and their so-called early communications with past practices of waiting to notify the public, including docs, until side effects were clearly linked to a med.

“I feel strongly it’s important for us to communicate early, but in communicating early we are acting with a much smaller degree of certainty,” FDA commish Andy von Eschenbach told the agency’s new risk-communication advisory committee during its inaugural meeting the other day, The Wall Street Journal reports. But, “we are trying to get people to understand that we haven’t said there’s a problem, only that we are concerned there’s a problem.”

The advisory panel, which is made up of outside academic and industry experts, has been established to help the FDA better communicate risks and benefits to the products the agency regulates, the paper notes. “It’s a time in which, quite frankly, if you look at external data there has been an erosion of trust,” Andy continued. “Perhaps because they need to better understand and appreciate what we are doing people’s confidence has been eroded.”

Janet Woodcock, an FDA deputy commish and acting head of the agency’s drug center, told reporters this week the FDA is finding more side effects, mostly because the agency is looking for them after drugs are put on the market. Until Congress approved new legislation last year giving the FDA additional money and authority, much of FDA’s drug-center budget was aimed at reviewing drugs to get them on the market rather than continuing to monitor drugs once they are on the market. “Consumers will know we are on the case,” she said, although as we have pointed out, many FDA pronouncements are made on Friday afternoons, when news is easily missed as the world prepares for the weekend.

However, she explained that the agency’s goal is to find out which consumers benefit the most from a particular drug and which ones should avoid it, rather than pulling drugs off the market, a notion that’s becoming more of a reality with increased use of genetic testing, the Journal reports. She added the FDA is still working on a public-private network that will allow the agency to more quickly track side effects by tapping into medical databases as well as updating the computer software that runs the agency’s own adverse-event reporting system to make it easier for FDA staff to track problems.

So far this year the FDA has issued four public-health advisories, which are aimed at warning the public about a particular health problem, and at least three so-called “early communications” after issuing 11 public health advisories involving drugs for all of 2007. The agency also highlighted a warning about suicides associated with epilepsy drugs that was aimed at doctors. According to agency’s web site, 16 drug-related public health advisories were issued in both 2006 and 2005 compared to five in 2004, two in 2003 and one in 2002.

One advisory, issued Feb. 1, involved Pfizer’s Chantix smoking-cessation drug and warned about severe changes in mood and behavior in patients taking the drug. It followed a previous “early communication” issued in November that said the agency evaluating reports of suicidal thoughts and aggressive and erratic behavior in patients who had taken Chantix.

On the other hand, the Journal reminds us that the FDA has cleared drugs after previously stating it was looking at a problem. In January the agency said a review of clinical studies involving AstraZeneca’s reflux drugs Nexium and Prilosec don’t show an increase in heart attacks and sudden death.

Source: The Wall Street Journal