If It’s Friday Afternoon, Must Be Big FDA News

Over the past few years, the FDA has sometimes issued important news - including health advisories - on Friday afternoons. Why does this matter? For one, releasing anything late in the day means the news is more likely to get lost as the media face looming deadlines. This may matter less as more people get their news from the Internet, but the public may also be paying less attention as their day draws to a close. This is especially true on a Friday afternoon, when people are finishing the work week and focusing on other things.

Yet, the FDA persists in issuing health advisories on Friday afternoons. For instance, last Friday, the agency issued an advisory about serious side effects, including deaths, associated with Botox. The week before, there was news about upgraded warnings on the labeling for the Chantix smoking-cessation drug, and on Jan. 25, the agency announced plans to review Vytorin clinical data. The FDA likes to trumpet its ‘early communications,’ but the agency never promised this meant early in the day, when important health news can be more fully circulated and digested.

So over the weekend we wrote Julie Zawisza, the FDA’s associate commissioner for public affairs, and she wrote back to acknowledge that the timing is a problem, although she maintains this is unintentional. She also says the issue is being reviewed. We hope so. After all, a Friday afternoon is when a company likes to sneak out a release with bad news. The FDA shouldn’t be doing the same thing, even if it’s inadvertent. Here is her reply…

“We have discussed internally how we may work to minimize the late Friday announcements. This is difficult to control….

“…The behind the scenes work on any issue involves many people and many steps before we get to the public communications stage and once we have the information ready we don’t want to sit on it. If we could say - “let’s make a public announcement on x day at y time,” say Wednesday at 10 am, that would be one way to minimize the late Fridays. And we do plan and try to work within a schedule. But often we can’t work backwards like that with an emerging safety issue because we don’t know when we will be ready until were ready.

“Our first priority is public health and, as an FDA safety announcement is expected to have an impact on public health, we must balance getting out the information as soon as we have it with the likelihood that media will pick it up. Obviously, if we put it out and you all don’t pick it up it defeats the purpose.

“Our default is NOT to issue press late on Friday if possible - we understand the news cycle and the impracticality of expecting news outlets to pick up the story at that time and the burden it places on all of you.

“There is tremendous coordination within the agency as well as externally that must happen before these announcements are made. Sometimes key information must be gathered from other parts of the country or in coordination with other government agencies, and discussions among these groups happen at various times of the day and week, often throughout the week, pushing us to Friday. For example, the E coli in spinach investigation included daily briefings with CDC and our field operations in California in mid to late afternoon, after they had collected the day’s epidemiological and iinspection data, which resulted in daily media briefings around 6 pm each day including Fridays. Certainly not optimal but the way we had to do it.

“Again, our goal is NOT to issue a press release late on Friday. By the time everything is in place and it is late on Friday we are faced with - do we issue now or wait until Saturday morning? Often, we don’t want to wait until Monday because people may have used the product over the weekend and we are hoping that at least the wires and broadcast outlets can get out the word. For pediatric medications or vaccines we especially don’t want to wait until a Monday because children may see a pediatrician on Saturday.

“We use other communication tools besides a press release and media call to notify health care practitioners and patient groups, but do see media coverage as a very important means by which to get out the information broadly and quickly.

“In sum, we share your concern and are looking for ways to address, recognizing that we are working with very complex issues often with many players and moving parts that all must come together before we can make a public announcement. Why all things seem to converge on Friday is certainly not intentional and I appreciate the continued reminder that we need to avoid when we can.”

Hat tip to the In Vivo blog for reminding us about the timing, which we’re sometimes too busy to notice ourselves.