FDA Promises More Aggressive Regulation of In Vitro Diagnostics.  Diagnostic tests and laboratory-developed tests may face heightened scrutiny under the new FDA leadership, the incoming director of FDA’s Office of In Vitro Diagnostics said at a July 20, 2009 meeting.  Alberto Gutierrez says that device firms that produce diagnostic tests can expect more aggressive regulation of their devices, both with respect to labeling claims, intended use statements, and other elements of premarket notifications for new tests.  Additionally, laboratory-developed tests, which FDA historically has not regulated, may see more attempts by the agency to regulate their quality and standardization. 

FDA Unable to Determine its Funding Needs.  FDA currently may lack the funding necessary to regulate the drug, device, and biologics industry, according to a new report released July 20, 2009 by the Government Accountability Office (“GAO”).  The GAO also found, however, that FDA lacks the ability to determine how much funding the agency needs to fulfill its mission.  According to the GAO, the agency does not have the requisite data about its resources, workload, and performance to calculate appropriate budgets for the agency.  The report recommends that FDA assess its staff resources and then create an evidence-based estimate of the resources it needs. 

FDA Advises Device Companies on Corrective Actions.  Corrective actions applied by device companies when a problem occurs with a device must be applied systematically, according to FDA quality systems experts.  FDA compliance staff note that companies often “stop at the correction” rather than taking a systemic look at whether any similar events were reported and why the problems with the device occurred.  Agency representatives encourage device firms to use a device failure investigation as an opportunity to evaluate their entire quality system, to prevent the problem from recurring in the same or other product lines.  

Health Reform Could Include Device Registry.  The health reform bill introduced in the House of Representatives on July 14, 2009 by Rep. John Dingell (D-Mich.) includes a provision to create a national medical device registry.  The registry would help assess postmarket safety and effectiveness for all class III devices and some class II devices, by linking information provided by device companies with existing sources of outcomes data.  Device industry trade groups say the registry is too broad in scope and would be repetitive with existing registries.

Massachusetts Code of Conduct Takes Effect.  On July 1, 2009, the Massachusetts law governing relationships between health care providers and drug/device makers went into effect, requiring medical device companies to implement a marketing code that complies with the strict state rules.  The state rules include a gift ban, which Massachusetts says is consistent with the existing AdvaMed code of ethics.  However, industry trade groups say the gift ban is stricter than existing codes and unclear, despite three guidance documents published to aid industry in complying with the new law. 

Device Firms Concerned Health Reform Could Stifle Innovation.  The House health reform bill includes provisions for new health care delivery models, many of which provide financial incentives for lowering the cost of service and improving health outcomes.  Device industry trade groups are concerned, however, that the bill does not include a special accommodation for innovative technologies that may be more costly than older methods.  Industry representatives urge that the bill be revised to ensure that physicians are not penalized for using new, emerging technologies.  

Lawsuits Lodged Against Cardiac Device Companies.  On July 10, 2009, the Department of Justice unsealed information regarding lawsuits against five medical device companies for off-label promotion of cardiac ablation devices.  A sixth device company settled a similar lawsuit on July 14, 2009, agreeing to pay the government $1.4 to put to rest allegations of off-label promotion and Medicare fraud.  The lawsuits were filed between 2007 and 2008 by an unnamed whistleblower who is a former employee of one of the device firms.  

Commissioner Seeks to Restructure FDA Front Office.  FDA Commissioner Margaret Hamburg recently sent a proposal to the Department of Health and Human Services, seeking to reorganize some of FDA’s divisions and programs.  The proposal does not suggest any modifications to the Center for Devices and Radiological Health, but Hamburg proposes that the Office of Combination Products now report to the new Office of Special Medical Programs.  Additionally, FDA policy staff and budget staff would now work together in the new Office of Policy, Planning and Budget, which would be led by a single deputy commissioner. 

AdvaMed Urges CMS to Reimburse for Devices Aimed at Infection.  In May, the Center for Medicare and Medicaid Services (“CMS”) issued its proposed inpatient prospective payment system for 2010, which lays out the amount Medicare will pay for inpatient hospital procedures occurring in fiscal year 2010.  In a June 30, 2009 comment on the proposed rule, device-industry trade group AdvaMed suggested that CMS evaluate and consider reimbursing for medical devices aimed at detecting and preventing hospital-related infections.  The comments specifically recommended advanced diagnostic tests, venous access points, intravenous catheters and access valves, as well as disposable blood pressure cuffs and intensive care unit monitoring systems.