There are few better ways to bury news than to send out a release on Friday afternoon. The FDA announced this past Friday afternoon that it would begin to post potential safety issues on the Internet. There are those who will applaud this new level of transparency, particularly in Congress where it was urged, but what will it really mean for patients and what will it mean for those who work in communications for the companies that manufacture the drugs that are mentioned on the list.
For the former: "My message to patients is this: Don’t stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently," said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.
For the latter, there will be one more milestone for which one needs to plan. Right now, there are clinical trial milestones, NDA submission and acceptance, advisory committee meetings, FDA decision and if positive, launch. Post launch, there are post-marketing commitments, high profile adverse events and warning letters, to name a few. Laced through all of these are unexpected crises (like finding out an investigator is not a doctor, an investigation by a member of Congress, etc.). Now there is one more to add, the quarterly publication of the FDA’s listing of potential safety issues.
It is too early to tell the impact of this publication. Will news rooms echo it? You can bet lawyers will collect them. Will disease-specific medical societies take note and collect those that pertain to their membership and re-publish them? Will they affect the outlook of analysts? Will it have a stock impact (perhaps that is why the Friday afternoon posting?) I don’t know the answer to all of these questions, but I suspect the answers to at least some of them will be YES.
And perhaps most importantly, what is the process by which drugs end up on the list? According to the FDA Press Release – Drugs that appear on the agency’s new AERS-based table, titled "Potential Signals of Serious Risks/New Safety Information," are identified by FDA reviewers based on reports from the FDA’s AERS database, which contains millions of reports of adverse events submitted to FDA by drug manufacturers, health care professionals and patients. For a drug to appear on this report, an FDA reviewer will have determined there is a reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug. The drugs for which issues have been identified are under evaluation for the listed potential risk.
The FDA Web site that houses the reports states the matter with a little more particularity – FDA staff in the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regularly examine the AERS database as part of routine safety monitoring. When a potential signal of a serious risk is identified from AERS data, it is entered as a safety issue into CDER’s Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) or into CBER’s Therapeutics and Blood Safety Branch Safety Signal Tracking (SST) system. Potential signals of serious risks are normally based upon groups of AERS reports, although a single AERS report could lead to further evaluation of a potential safety issue.
For all that, the actual list doesn’t yield much information. It only says the name of the drug by generic, then by brand name, and then a very brief description of the potential signal. For example, the list contains the following "Desflurane (Suprane) – Cardiac Arrest". Not much to go on. This may be a classic example where a little information becomes a dangerous thing. How many instances were there, what other drugs were the people taking, what percentage have been affected, what does the drug treat? If you want to know the answers to those questions, you’ll have to dig further and perhaps even file a Freedom of Information Act request (good luck with that) to find out.
One last thing – according to the Fact Sheet issued by the FDA, "if a drug appears on the AERS-based quarterly report, it means that FDA has begun an analysis to determine whether there is a safety problem. However, depending on the level of analysis completed, it may be too early to know whether there is a safety problem, and FDA’s analysis may ultimately conclude that there is no safety problem. As the FDA completes its analysis of drugs on the list, if a safety problem is found, the agency will take action to protect consumers." What they do not say is if no safety problem is found whether or not they will remove a drug from the list if, in fact, no problem is demonstrated. Perhaps that is yet another example of the current environment that emphasizes risk over benefit. There is no vindication, only condemnation.
I’ve written lately about the need for communications teams to adapt to the new Complete Response Letter change. This development may merit more adaptation.