It has been a busy week for Senator Charles E. Grassley (R-Iowa). In one of seven press releases he sent out about his activities on December 8, it was announced that the Senator was asking for information from thirty-three medical groups about their financial dealings with medical product manufacturers in what has been an on-going and unyielding fascination with this topic. But he got other mail as well, including a report from the GAO called Drug Safety: FDA Has Begun Efforts to Enhance Postmarket Safety, but Additional Actions Are Needed.
GAO reports are important for trend spotters. They offer pretty reliable indications of new directions for change that will impact the status quo. First, they offer insight into what topics and priorities policy-makers in Congress have in a particular area. Second, the recommendations offer a road-map for stakeholders that, if they undertake, they can get said policy-makers off their backs.
In this case, the GAO issued a report in March 2006 entitled – Improvement Needed in FDA's Post-Market Decision Making and Oversight Process. In that report, the GAO opined that the agency "had not clearly defined the roles of two offices involved in making decisions about postmarket safety – the Office of new Drugs (OND) and the Office of Surveillance and Epidemiology (OSE)."
While the report issued this week sites progress in addressing some of the issues raised in the 2006 report, there was one statement that was very emblematic of FDA's problems in general. "FDA has begun to formalize OND and OSE's Decision-Making process for postmarket drug safety, but a time frame for implementing key elements has yet to be established."
One could take that statement and apply it to almost any reform initiative at FDA, and it would stand true.
The FDA's once gold standard image was highly tarnished by a number of high profile lapses, compounded by a lack of visionary leadership for the agency. Now there is strong leadership that has taken the first steps at restoring that image by enunciating clear goals to make the agency rooted in the protection of public health agency once again.
But that noble goal is not enough. As clearly pointed out by this GAO report, process and timing are just as important as the goal. As the FDA has embarked on a new transparency initiative, an essential component of FDA restoration is going to be enunciating priorities, processes and time frames to all major initiatives so that progress is clear to all stakeholders. Without that, there will be more GAO reports like this one, people won't understand what the expect, and the tarnish will be all the more difficult to clean off. Announcing that process and time frame for postmarketing drug safety and evaluation is a good place to start.