Congress’ Remedy for Post-marketing part 2
When Caroline Loew, PhD, Senior Vice President of Scientific and Regulatory Affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA), appeared before a House committee in May 2007, she gave a more expansive analysis of MedWatch’s flaws:
One of the shortcomings of this system is the variable nature of reporting and the quality of reports. Ultimately, any database is only as good as the underlying data, and one of the chief difficulties with adverse event report databases is quality. Precious resources are often expended in contacting health care professionals regarding aspects of a report they have filed. In many instances, the reporter is unable or unwilling to provide sufficient detail for analysis. suhagra 100
The FDA has been moving on its own to address this problem. At the start of 2007, the agency announced steps it would take with the extra $90 million it expects to receive in fiscal 2008 from the higher PDUFA fees that Congress is in the process of authorizing.
One step would be to publish a request for proposals from outside research organizations that would assist in determining the best way to maximize the public health benefits associated with collecting and reporting serious and non-serious ADEs throughout a product’s life cycle.
Central to addressing this question are:
- determining the number and type of safety concerns discovered by collecting the reports of ADEs.
- the age of products at the time safety concer ns are detected by the collection of ADEs.
- the types of actions that are taken next to protect patient safety.
In early March, the agency took the next step by sponsoring a public meeting to explore opportunities for linking post-marketing monitoring systems in the private and public sectors to create a virtual integrated, interoperable nationwide medical product safety network. Such a “sentinel network” could integrate existing and planned private and public sector databases to enable the collection, analysis, and dissemination of safety information about medical products to health care professionals and patients at the point of care; that would be in the clinic, where this information is needed to make informed decisions about safe and effective treatments.
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One of the Kennedy provisions in the FDA Revitalization Act essentially seconds the FDA’s motion toward a sentinel network. It authorizes a public and private partnership to establish a routine active monitoring system that would create a “pool” of relevant data assembled from federal and private electronic databases of the health care population. This apparently would be a complement to—or even a rival to—MedWatch. According to the Kennedy bill, the data pool would have to have 25 million patients swimming it by January 1, 2009, and 100 million patients by January 1, 2012.
Although Senator Judd Gregg (R-N.H.) backed a competing bill called the Safer Data bill, he agrees with Senator Kennedy’s challenge to the FDA that it set up an active surveillance system. However, he claims that the Kennedy timetable is too leisurely:
I strongly support this in concept but feel the language needs to be strengthened to ensure that the FDA has the direction it needs to implement a robust system in an expedited timeframe. Information collected must be standardized, and the overall system should be validated.
Despite Senator Gregg’s criticism, it is difficult to see how the FDA could assemble a pool of 25 million electronic health records (EHRs) on Kennedy’s timetable, much less on a faster one. There are 85 million Medicare and Medicaid recipients, but neither of those two federal systems has mandated that physicians produce EHRs. In the private sector, Kaiser Permanente has been the leader in developing EHRs, and it now has them for half of its 8.5 million patients, according to Paul Wallace, MD, Medical Director of Health and Productivity Management Programs at the organization.
The Kennedy proposal, which the House will probably accept, does nothing to correct MedWatch’s debilities. It simply layers a new early warning system based on EHRs on top of Med-Watch. However, a second Kennedy proposal promises a better benefit in the near term.
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Another element in the Kennedy-sponsored FDA Revitalization Act allows the FDA to order drug companies to prepare Risk Evaluation and Mitigation Strategies (REMSs) for new drugs; this might go a long way toward completing post-marketing studies more quickly.
There is no question that drug companies have fiddled with completing these studies, which explains why nearly everyone in Congress is livid. The FDA itself has acknowledged that drug companies decline to perform a significant percentage of the post-marketing studies requested.