Collaboration Between CMS and FDA Would Alter Post-market Surveillance
James R. Ravitz Jeffery Weinstein |
Indeed, the FDA itself has tried through various methods to patch what has been referred to as “holes in the safety net.” In mid-June, FDA officials publicly expressed their support of an innovative proposal to improve drug surveillance through collaboration on a shared database with the Centers for Medicare and Medicaid Services (CMS). This article looks at the present-day challenges to device surveillance and assesses the implications that a similar FDA-CMS collaborative database venture might have for device companies.
Monitoring Safety
Viewed broadly, postmarket surveillance of medical devices is the systematic collection, analysis and interpretation of data about the actual historical performance of legally marketed devices. FDA guidance indicates that one purpose of postmarket surveillance regulations is to provide a warning system for the early identification of potential problems within a reasonable time of a device’s initial marketing. Beyond identifying problems, the regulations are intended to facilitate development of safety warnings, provide information not available from the medical device reporting regulation and provide actual use of safety and effectiveness information.
Postmarket surveillance can take various forms. First, the FDA may impose “post-approval” or “condition-of-approval” study requirements to develop additional performance data. Section 522 of the Federal Food, Drug, and Cosmetic Act grants FDA discretion to require manufacturers to undertake “post-approval” studies to gather safety and, sometimes, effectiveness information for certain Class II and Class III devices. More broadly, the FDA can require as a condition of device approval, that the manufacturer undertake studies to collect more information about the device’s safety or effectiveness. These “condition of approval” studies often investigate safety questions that remain unanswered at the time a device is being considered for approval.
Second, the FDA also has discretion to order manufacturers of certain Class II or Class III devices to initiate programs to enable them to track their medical devices to actual patients. The tracking requirement is intended to ensure that manufacturers can quickly remove potentially dangerous or defective devices from the market and and/or notify patients of significant device problems. Guidance indicates that tracking “augments” the FDA’s authority to order mandatory recalls and to require notification of health professionals and patients regarding unreasonable risks of substantial harm associated with a device.
Third, the FDA has established systems for mandatory and voluntary adverse event reporting. Under the Medical Device Reporting requirements, for example, manufacturers, user facilities (e.g., hospitals, ambulatory surgical facilities, nursing homes) and distributors must report deaths or serious injuries to which a device has or may have, caused or contributed. The FDA Modernization Act of 1997 directed the agency to develop a new framework for user facility reporting (“MedSun”). Among other changes, MedSun replaces universal user facility reporting with a system limited to a subset of user facilities that constitutes “a representative profile of user reports” of device-related deaths and serious illnesses or injuries. Beyond mandatory reporting, the FDA also encourages health professionals and consumers to report adverse events on a voluntary basis. To this end it has developed the MedWatch safety information program.
The FDA’s various postmarket surveillance arrangements are alleged to have fallen short of achieving their intended purpose to provide an early warning system for potential problems with marketed devices. Critical reports from both inside and outside FDA have documented the large extent to which problems go unreported or underreported in the context of both the studies requirements imposed on individual manufacturers and the adverse event reporting system. These findings appear to be supported by the recent safety crises in connection with legally marketed devices, including pacemakers, cardiac stents and infusion pumps.
CMS-FDA Collaboration
The FDA has attempted on several occasions to patch the holes in its ability to conduct post-market surveillance, but these efforts have yet to achieve much success. One idea long under consideration has been for the FDA to share data with CMS, its sister agency at the Department of Health and Human Services (DHHS). Collaboration advocates at the FDA have argued that maintenance of two separate agency databases results in the wasteful duplication of DHHS assets and hampers the ability to ensure that marketed products are safe for their intended use.
In June, leading FDA officials, including the head of the Office of Drug Safety, declared strong support for a database-sharing proposal from CMS Administrator Mark McClellan. Various reasons may have prompted this change of position. With the recent Guidant and Vioxx crises, and safety problems with antidepressants and other products, pressure has been mounting in Congress and at DHHS and the FDA for improving the safety monitoring system. Another factor was probably McClellan himself. A Bush appointee and strong advocate of CMS-FDA collaboration, he has been well-situated as CMS administrator to advance the database-sharing initiative. McClellan previously served as the FDA commissioner and no doubt still wields influence at the FDA.
McClellan envisions FDA and CMS sharing post-market drug data, in particular, billing data and adverse events reports that are to be collected in connection with the new Medicare prescription drug benefit program. It has been reported that the shared database arrangement would permit computer programs to search for statistical associations between products and associated adverse medical outcomes to supplement existing FDA post-market data.
We find the idea of the FDA sharing a database for post-market devices with CMS to be an intriguing possibility for a variety of reasons. The FDA would gain access to the data for Medicare recipients (currently about 41 million and growing). This would have the potential to greatly augment the present post-market surveillance data available to the agency. The shared data would eventually allow investigation of device performance, effects and interactions over a far longer period of time than the handful of years that are generally allotted to clinical studies. We believe that the collaborative approach would allow the FDA to exploit CMS’ relatively underutilized database resources to shore up the FDA’s surveillance system.
Of course, there are limits to the benefits to be gained and considerable hurdles still to overcome. One constraint is the fact that Medicare data would not be representative of the general population or pediatric patients. Further, the Medicare population represents a group far more likely to undergo simultaneous treatments for multiple ailments. Drug and device interaction effects may further constrain use of the data. It should be noted, finally, that if the CMS database is dependent on product billing codes, flawed data may enter the system as a result of improper coding.
Despite the shortcomings, many events left unreported to the FDA may very well appear in the Medicare database. Under the collaborative arrangement, FDA officials would have access to Medicare billing data, which should ultimately benefit public health if the CMS database is monitored.
When device and prescription drug companies realize that FDA officials have these capabilities, we suspect that there would also be a cultural shift in terms of a company’s voluntary surveillance activities. Companies that had been content to allow adverse events to pass unreported (or underreported) would suddenly feel vulnerable to detection, prosecution and liability through the FDA’s access to Medicare patient data. Attitudes at companies that sell products to Medicare beneficiaries may shift from complacency to wariness regarding unreported and underreported events. Thus, considerably more energy might be invested in post-market compliance. Changes in a company’s compliance culture, then, might represent the greatest single benefit of an FDA-CMS collaborative database venture.
James R. Ravitz and Jeffrey Weinstein are attorneys with Arent Fox PLLC, a general practice law firm based in Washington, D.C. They specialize in FDA regulatory matters and counsel medical device companies in issues relating to device approval, compliance, reimbursement and marketing and advertising. For additional information, contact: Ravitz.James@arentfox.com or (202) 857-8903.