The New FDA Drug Safety Initiative – Policy and Communications Implications

J0174976 Yesterday the FDA announced yet another new initiative on drug safety.  This is apparently in addition to the pre-existing Drug Safety Initiative.  It is an action taken in response to the Institute of Medicine (IOM) report – The Future of Drug Safety – that soundly thrashed the FDA’s approach to safety issued in September of last year.

As a result, the FDA has entered some new chips into the game.   One of them, per the FDA Fact Sheet on this new safety commitment, is the development of a new advisory committee on Risk Communications.  We’ll leave that for later. 

But another is that the agency is going to issue "report cards" in the words of ABC News.  Following 18 months after the approval of a drug, the FDA is going to issue a report on that drug’s post-marketing safety issues.  The actual description of these "report cards" contained in the FDA Report report seem somewhat vague on the details.  The FDA report is titled The Future of Drug Safety — Promoting and Protecting the Health of the Public FDA’s Response to the Institute of Medicine’s 2006 Report

Consider this passage:

In 2007, we plan to regularly publish a newsletter on the FDA Web site containing summaries of the results, including methods, of FDA post-marketing drug reviews. The summaries will not include confidential commercial or predecisional information. We believe it is important, particularly for healthcare professionals, for FDA to make readily available and easily accessible the results of our post-marketing reviews of adverse events. In addition, this regular newsletter will contain information on emerging safety issues, as well as provide information on recently approved products both to inform providers and to encourage reporting to the Agency.

But the preceding paragraph raises a caveat that makes it unclear what exactly is going to be in these newsletters:

FDA recognizes the importance of communicating information about the safety of drugs. However, many post-marketing assessments contain recommendations that are the subject of ongoing discussions within FDA and other information that is predecisional in nature. Release of such information could have adverse public health impacts. For example, release of information about a safety signal that is later determined to be erroneous could result in patients who could benefit from the drug not receiving it. Therefore, decisions to publicly disclose assessments of post-marketing safety studies have to be made on a case-by-case basis.

What ever these newsletters do or don’t exactly include nevertheless presents a whole new challenge to public relations supporting drug marketing.  If there is to be a safety "report card", however bold or timid, it becomes a new milestone to figure in to the existing mix of clinical and regulatory milestones. 

Consider, for example, two new drugs in a new class are approved at or about the same point in time, such as was the case of Actos and Avandia.  Their reports would then also come out at or near the same time.  If this newsletter provides any insight at all, it could be a signal to patients, physicians, key opinion leaders and investors that one drug is better than the other.  Unless the information to be contained in these newsletters is so vanilla as to be of no use at all, then with the advent of these newsletters, the FDA is adding an important new communications milestone in the life cycle of any new drug.  Marketing and public relations teams, take note

Needless to say, the issue of safety is not going to go away during the post-COX-2 issues and the emphasis of risk over benefit is going to continue.   

By the way, this FDA action comes pre-emptively before a re-introduction of the well known Kennedy Enzi bill on drug safety, which, when it appears, will be carried here on the Blog Site to the column at your left at

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