As mentioned in the Weekly Roundup on Friday, the HHS Office of the Inspector General Report on the Food and Drug Administration’s Oversight of Clinical Trials was published on Friday. The report raises a number of issues with the way that FDA oversees clinical trials, including the agency track record for checking up on sites after issuing a Warning Letter.
Refresher on Warning Letters. Warning Letters come out of several areas of the agency. The FDA issues Warning Letters itself. These are often generated by the field or regional offices and involve adulterated products or manufacturing processes. There are Cyber Warning Letters and there are DDMAC Warning Letters. They are all housed in different spots on the FDA site.
In news articles related to the report, FDA’s Dr. Janet Woodcock stated that the agency is working on the problems. Dr. Woodcock is the former head of CDER and the current acting head of CDER (not that Dr. Galson has headed to be Acting Surgeon General), as well as wearing several other hats at the agency, including Chief Medical Officer. She has a lot on her plate.
But there is one question bothering me about the report that I have not yet seen discussed. The report is a snapshot of how the agency is currently doing on this front, but one has to consider enforcement activity in the greater context of the Administration’s approach to enforcement in general. Recently there have been reports that the Environmental Protection Agency, among others, has been lax in enforcement. For example, recent reports in the Washington Post note that "[t]he number of civil lawsuits filed against defendants who refuse to settle environmental cases was down nearly 70 percent between fiscal years 2002 and 2006, compared with a four-year period in the late 1990s, according to those same statistics."
As I’ve noted here before, there is a similar drop off in the number of Warning Letters issued by DDMAC on behalf of the agency from a peak of 156 in 1998 to only 22 in 2006. This year does not appear to be faring much better.
The Administration is no stranger to inserting political imperatives on the efficacy of an agency, as noted when the former Surgeon General Carmona described the pressure the Administration put him under to bend his views and mission according to their political needs.
Therefore, the question that stands out about the report is this – Is the lack of enforcement the fault of the agency and the approach it has always taken to oversight over clinical trials, or is the lack of enforcement cited in the report part of a broader pattern of policy being set down by the Administration? I think it is an important question to ask before condemning the agency.