A Senate hearing will address allegations of payments by medical device companies to physicians and hospitals (read here). This issue has been partially explored previously in this blog, read here. Officials from some of the companies which have been in the news lately will be testifying. More to follow after the news reports of the hearing are published.
The FDA today released a draft guidance document on the issue of the dissemination of medical literature about off label uses of drugs and devices. You can find the FDA statement here, and the draft guidance here. The public comment period ends, and you may start the process of commenting by clicking here.
Henry Waxman, late of Roger Clemens bashing and Brian McNamee annointing, has previously been critical of this anticipated draft guidance (See Rep. Waxman's web site here) and we can expect more criticism.
What does the guidance say? First, it covers drugs, devices and biologics. The agency expresses the public health benefit of dissemination of medical literature to the medical community. A countervailing consideration is that inappropriate promotion of a drug/device for an unapproved purpose makes the device adulterated and misbranded.
How do you strike the balance? Physicians are free to use approved devices in accord with their judgment (subject of course to good and accepted medical practice) and they may write in the medical literature about their experience. If a manufacturer is going to disseminate literature that is 'off label' the agency recommends best practices, some of which are highlighted below:
Read here an article in the Corporate Crime Reporter which discusses criticism of the FDA for failing to debar convicted felons - and the post talks about a specific conviction reportedly related to the performance of a clinical trial - after conviction. An interesting point is that the debarment provisions are apparently only available as to the manufacturers of generics, and not brand names.
Given all of the recent discussions about inadequate funding of the FDA, it is a delicious irony that the congressman quoted in the post indicates that the FDA budget will be cut if it does not debar felons. In other words, it may not have enough money to do its job properly, so let's punish it for not having enough money by cutting its funding further. Washington DC is a strange place indeed.
The post is based on a House sub-committee report by the Republican Committee members, and a link to the report is contained in the post.
This post is being belatedly written as I have been quite busy with my day job. I am on my way back from the DRI Products Liability seminar in Phoenix where I was a speaker, and am trying to catch up.
For those who do not know, DRI is the largest organization of civil defense attorneys in the United States. If you are interested in learning more about it, their website is www.dri.org.
Back to the post. The federal Government Accounting Office raised concerns about the lack of oversight of foreign medical device manufacturers. The concern is that they are not doing it, and that they do not have the funds to do it.(read here)
Some of the criticisms. I raise these because they can directly impact the ability of medical device companies to attempt to use the FDA's oversight of its products and manufacturing as a defense in product liability cases. The more it can be shown that the FDA is not able, by means of funding or will, to be involved in the oversight of the medical device industry, the more difficult it will be to try to use FDA involvement as a partial, or full defense in medical device cases.
The FDA released a Public Health Notification today directed to health care practitioners about adverse events associated with unretrieved medical device fragments. The FDA states that it receives more than 1000 adverse event reports each year of such fragments from more than 200 devices and across medical specialties.
The FDA has a number of recommendations which are outlined below:
The Notification encourages Medwatch reporting as well.
inspection of the product before implantation, and after explantation would seem to be a no-brainer. Same for following instructions for use.
Sending the product to the manufacturer is a very good step to take as it can and does greatly assist with ascertaining the cause(s) of the problem, and with developing methods for preventing the problem in the future. Often, for medical legal reasons, a hospital may be reticent to send the device back, but the better practice would be to have it sent back for analysis and evaluation.
An informed consent discussion with the patient is always a good idea.
The Seattle Times continues its investigative reports on the supposed 'Miracle Machine' with a report today that the machines discussed in previous posts (December 7, 2007 and December 9, 2007) have had the dubious claims about their use removed from websites that sold the devices. The claims about these devices are now limited to stress relief - whatever that means. Claims that they can cure cancer and AIDS have been removed.
The vendors of these devices would seem to me to have opened themselves for potential exposure for unproven claims that have been made in the past. Claims concerning such 'snake oil' devices serve no useful purpose, and can cause people to question claims made by the legitimate medical device community.
One day, it may be shown that such 'energy devices' are safe and efficacious. Until that is done, it is good to see that vendors are no longer making unproven health claims.
The FDA has issued a Public Health Notification relative to the off label use of an ablation device due to several reported patient deaths. The approved use of the devices, which destroy/ablate tissue by the use of high heat, includes the treatment of non-resectable liver cancer and for pain associated with bone metastasis.
Some surgeons have been using the devices for the treatment of lung cancer, and it is in this context that the deaths have occurred.
Off label use is legal; however, it must be remembered by physicians, and in my view disclosed to patients, that the device has not been studied by the manufacturer, and approved by the FDA for safety and efficacy.
Due to the reported deaths, the FDA specifically cautions physicians to follow the instructions for use, and that there are clinical trials available for patients to enroll in. The FDA Notification also reminds the health care practitioners of their responsibility to report adverse events to the FDA.
For a related posting about proposed new rules for manufacturers and how and when they may provide information about off label use of medical devices, see one of the first posts in this blawg from last week.
Today's oral argument: CNN is reporting that the US Supreme Court seemed inclined to agree with Medtronic that state tort claims should be preempted where the FDA has acted. Assuming the reporter is accurate in assessing the temperature of the Court, this will be good news for Medtronic and other medical device companies. The transcript of today's oral argument will be posted here when it has become available.
http://money.cnn.com/news/newsfeeds/articles/djf500/200712041353DOWJONESDJONLINE000610_FORTUNE5.htm
http://www.nytimes.com/2007/12/01/washington/01fda.html
The New York Times reported on a report of the FDA Science Board criticizing the agency as being short of money and poorly organized. The advisory panel believes that the appropriations for the agency are insufficient for its public health responsibilities.
It remains to be seen what effect reports like this may have on the efforts of those representing the industry to have FDA actions protect manufacturers under the preemption doctrine. The concern here is that if the courts believe that the FDA does not do its job adequately, then efforts to strengthen the preemption doctrine may be less successful.
Mike Shalhoub
Goldberg Segalla LLP
