FDA Commissioner Margaret Hamburg issued notice yesterday that the FDA is going to be laying down the law. It has been oft-noted here on Eye on FDA that enforcement by the FDA has certainly been lax during the Bush Administration and that improvement should be expected. In her statement yesterday, Commissioner Hamburg made clear precisely how she is directing for enforcement to pick up again. There is no question that there will be greater scrutiny and greater action more quickly as a result.
Her objective is clearly to speed up enforcement actions and to remove some of the obstacles that made timely enforcement all but impossible under the old-FDA mindset. She has outlined six initial steps toward that end:
- Setting up post-inspection deadlines – giving companies a 15-day deadline to respond to issues or get a warning letter;
- Speeding up the Warning Letter process – no longer reviewed by Office of Chief Counsel unless there are significant legal issues;
- Work more closely with FDA's regulatory partners – i.e., state and local officials;
- Faster assessment of corrective actions taken after warning letters;
- More immediate responses to public health risks – possibly even before a warning letter is issued;
- Developing a "close out" to the Warning Letter process that is posted by FDA to the web site when issues are resolved.
This is a great way to shake things up and an important step in restoring FDA credibility not only to the public but to policy makers. As a result of these efforts though, one can look forward to an increase in warning and untitled letters and, if some members of industry fail to take note, an increase in consent decrees.
Her timing is also important. She has launched this initiative 8 weeks into her new job and on the heels of the FDA gaining new authority in tobacco marketing and about to get sweeping new authority in food safety. It is of particular importance for the food industry as they come to grips for how they will operate under the new food safety authorities to understand that the consequences of inaction in the face of this new determination on enforcement. And this action puts all FDA-regulated industry and those who work on behalf of them on notice to be even more careful and vigilant about strategically approaching communications to ensure that regulatory tripwires are not violated.
I welcome a tougher stance on enforcement of FDA regulations. I think that Dr. Hamburg is off to a good start. However, I have some concerns that there will be unintended consequences. First, FDA has been going after some relatively easy targets, such as internet fraud for H1N1 “remedies.” Next, there needs to be a corresponding improvement on training FDA personnel so they adequately and fairly enforce the regulations. Many regulations are outdated. The clinical trial regulations date back to the 1970s and don’t address today’s issues.
You may read more of my viewpoints on my blog, Carl’s Blog on FDA Stuff, found at: http://carl1anderson.wordpress.com/