In what was top-line news on Friday, the Institute of Medicine (IOM) released a report entitled "The Future of Drug Safety: Promoting and Protecting the Health of the Public", requested by the FDA about the FDA. While the conclusions of the report was fairly damning, there wasn’t much, if anything, new. Much of it, such as the fact that the image of the FDA and the industry are intertwined and interdependent you would have seen here, or with other bloggers over the past several months.
Here is what they said, quoting from their release:
During its research, the committee found that
- There is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry.
- Most stakeholders–the agency, the industry, consumer organizations, Congress, professional societies, health care entities–appear to agree on the need for certain improvements in the system.
- The drug safety system is impaired by the following factors: serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture in CDER that is not optimally functional; and unclear and insufficient regulatory authorities particularly with respect to enforcement.
- FDA and the pharmaceutical industry do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion.
In order to fix the problem, the IOM made the following recommendations:
- Labeling requirements and advertising limits for new medications
- Clarified authority and additional enforcement tools for the agency
- Clarification of FDA’s role in gathering and communicating additional information on marketed products’ risks and benefits
- Mandatory registration of clinical trial results to facilitate public access to drug safety information
- An increased role for FDA’s drug safety staff
- A large boost in funding and staffing for the agency
Neither the problems cited, nor the recommendations are new and in fact, many were covered here in the recent series on the Next Ten Years in Healthcare Communications which were posted in the last month.
What is new is that IOM reports do carry gravitas that generally provokes reaction and momentum to create change. That said, only week before last did three infants die from adult doses of a drug mistakenly administered, several years after the IOM report on medical errors in hospitals. The lesson there – IOM Reports create awareness of problems, but cannot guarantee that those problems get addressed. That is up to institutions.
Here the institution is the FDA. The Acting Commissioner immediately issued a statement on Friday promising action, but referring in large part to measures that are already underway, such as the Critical Path and the Drug Safety Initiatives. Understandably he wants to put that out there, but it is going to take a great deal to put back the pieces of the venerable institution that has slid so far, so fast under this Administration.
As stated many times, the FDA needs a PLAN. It needs to be an operational plan, but it also needs to be a communications plan. The agency cannot crawl out of this hole by launching initiatives, the name of which mean very little to the general public, and expect a rebound in public confidence. Deeds alone will not prevail. The best plans for improvement will fail unless the agency gets far more savvy about the way it markets itself. Right now, it does not appear to understand that its future very much depends on that.
