June 2009 Regulatory Affairs NewsletterPrint this page

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Lawmakers Debate Legislative Changes to the 510(k) Process.  At a June 18, 2009 hearing of the House Energy and Commerce Health Subcommittee, Rep. Frank Pallone (D-N.J.) called for legislation to limit the medical devices that may be cleared for marketing through FDA’s premarket notification (“510(k)”) pathway.  Some witnesses testifying at the hearing agreed, noting that the types of devices requiring clinical data in order to be cleared via the 510(k) process also should be more clearly delineated.  Other lawmakers and witnesses, however, contend that the laws and regulations governing device reviews are sound, but FDA has been improperly applying these rules. 

Panel Recommends Use of Bayesian Statistics to Support Coverage Decisions.  At a recent meeting, a panel of the Medical Evidence Development & Coverage Advisory Committee (“MedCAC”) recommended that the Center for Medicare and Medicaid Services (“CMS”) allow the use of Bayesian statistics in clinical trials submitted to CMS to support covering a certain therapy under Medicare.  Bayesian statistics help to calculate the likelihood that a clinical trial will have a given outcome, based on whether that outcome occurred in similar prior trials.  Proponents say Bayesian statistics allow for smaller, quicker, and less-costly clinical trials. 

FDA, Industry Discuss Challenges to Universal Identifier System.  As FDA seeks to create a mandatory unique identification system for medical devices, which would track a device from manufacturing to patient use, the agency discussed ongoing challenges with industry at a recent conference.  FDA is likely to require some type of bar code to be placed on medical devices to serve as a unique identifier, but  industry representatives say many hospitals do not have the technology to scan such bar codes.  Thus, both the agency and industry fear that it will be difficult to create a unique identifier system that can be used at all phases of the medical device life cycle.  

Kennedy’s Bill Concerns Device Industry.  On June 9, 2009, Sen. Ted Kennedy (D-Mass.) proposed a health reform bill that the medical device industry worries could restrict coverage of certain devices.  The bill would require all Americans to purchase health insurance and utilizes an advisory council to define the minimum coverage that an insurance plan must offer.  The council would report annually to the Secretary of Health and Human Services on benefits that must be included in a qualifying plan, but the Secretary could reject the report and require revisions.  Device industry lobbyists are concerned that the Secretary could reject certain products in the report based on costs, and is seeking to add language to the bill clarifying that the council should recommend general services rather than specific therapies or products. 

Health Reform Bills Address Comparative Effectiveness.  Last week, both Sen. Max Baucus (D-Mont.) and Sen. Ted Kennedy (D-Mass.) introduced health reform bills, each with a provision for conducting research on the comparative effectiveness of certain health products and treatments.  The Baucus bill restricts the government from using the research findings to determine Medicare coverage decisions, while the Kennedy bill does not include such limitations.  The medical device industry seems to support the Baucus bill, out of concerns that comparative effectiveness research could be used to prohibit payment for certain devices under Medicare, due to costs alone. 

Whistleblowers Should Air Grievances Internally First, Industry Says.  Medical device firms are encouraging employee whistleblowers to report wrongdoing or fraud internally first, rather than reporting directly to the authorities.  Recent data indicate that 70% of whistleblowers involved in government investigations for fraud and abuse never reported their concerns to the company before initiating a complaint.  Device firms are concerned that many whistleblowers are unaware of internal processes that exist to handle such reports, and thus are urging concerned employees to utilize such processes. 

New Leaders Look to FDA’s Ability to Protect Public Health.  In a May 26, 2009 editorial in the New England Journal of Medicine, new FDA Commissioner Margaret Hamburg and her deputy, Joshua Sharfstein, outlined their philosophy and approach to leading FDA.  The two note that FDA’s success should not be measured by the number of product approvals or facility inspections, but by how the agency protects public health.  Both stated that risk-benefit assessments in product approvals should be made on an individual basis and promised to promote a culture at FDA that respects science and myriad viewpoints.  In a separate e-mail to agency staff, Hamburg emphasized the need to restore FDA’s reputation and regain public confidence in the agency. 

EU Medical Device Regulatory Overhaul on the Horizon.  The European Commission intends to revamp the European Union (“EU”) medical device regulatory landscape in the coming year, following the election of a new parliament this week.  According to Commission staff, a new EU medical device regulatory system should be in place by 2015.  The new system likely will merge directives that currently regulate different categories of medical devices, such that the new rules will apply to all devices aside from in vitro diagnostic devices, whose regulatory directives will be updated separately. 

Device Expenditures Represent Fraction of U.S. Health Spending.  According to a report by AdvaMed, a medical device industry trade group, spending on medical devices amounts to only 6.2% of U.S. health expenditures.  As Congress begins to tackle health care reform, AdvaMed released the report to demonstrate that spending on medical devices is low, despite a perception on Capitol Hill that over-utilization of medical technology may be the cause of increased health spending.  Though medical device spending has increased over time in terms of strict dollar amounts, its proportion of overall U.S. health expenditures has remained somewhat stable.  

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