News: January 16, 2008
FDA and NIH Partner to Centralize Adverse Event Reporting. The U.S. Food and Drug Administration (“FDA”) and the National Institutes of Health (“NIH”) are partnering to develop a centralized internet based adverse event reporting system. The aim of the collaboration is to lower costs, improve report quality, and reduce delivery time. A recent memorandum of understanding between FDA and NIH combines the efforts of the two. Until now, FDA has been working toward a single, agency-wide portal, called MedWatch Plus. Meanwhile, the NIH has implemented the Federal Adverse Event Task Force to develop a similar portal. The combination of these efforts is expected to create a portal that will allow any user to submit adverse event information electronically to a centralized database. Additional information is available at www.thegraysheet.com (paid subscription service).
FDA Publishes Guidance Documents on PMA Manufacturing Audits and Clinical Trial Inspections. On January 8, 2008, FDA's Center for Devices and Radiological Health’s (“CDRH”) published two new final guidance documents. The first, entitled, “The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations,” available at http://www.fda.gov/cdrh/comp/guidance/1566.pdf, describes facility inspection policies for premarket approval (“PMA”) applications and outlines FDA’s timeline commitments for such inspections, which the agency must meet in order to comply with user fee performance goal deadlines. The second, entitled, “The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program,” sets forth the timetables that medical device firms can expect when premarket approval applications and supplements are under review by CDRH’s bioresearch monitoring division. This document is available at http://www.fda.gov/cdrh/comp/guidance/1602.pdf. Additional information is available at www.thegraysheet.com (paid subscription service).
FDA to Establish Staff Positions Globally. The FDA is hoping to establish staff positions in a number of foreign countries. The focus of these staff would be to perform overseas inspections and to foster relationships with foreign governments and industry. FDA is concerned that its current approach is no longer adequate to perform its domestic duties and cites increasing concerns about the international implications of the agency’s work as a major driving factor. Agency officials note that the products regulated by FDA are increasingly global products. Although the agency hopes to establish a number of overseas posts, China will likely be the site of the first—negotiations to this effect are currently underway with the Chinese government. Additional information is available at www.thegraysheet.com (paid subscription service).
CMS to Expand DMEPOS Competitive Bidding. On January 8, 2008, the Centers for Medicare and Medicaid Services (“CMS”) announced that it will expand competitive bidding for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). New York, Chicago, and Los Angeles are among the 70 additional metropolitan areas for which competitive bidding will determine payments for eight product types: oxygen equipment and supplies; standard and rehabilitative power wheelchairs; enteral nutrition supplies; respiratory assist devices and continuous positive airway devices; hospital beds; negative pressure wound therapy pumps; and walkers. The bidding process is expected to begin this summer despite pressure to postpone any expansion until the current program’s impact can be evaluated. Additional information is available at www.thegraysheet.com (paid subscription service).
New Initiatives Create Market for Novel Device Interventions for Preventing Hospital-Acquired Infections . As state and federal legislatures and the public pressure hospitals to reduce infection risks, a stream of new medical devices aimed at preventing hospital-acquired infections is hitting the market. According to the Centers for Disease Control and Prevention, approximately 1.7 million Americans experience hospital-acquired infections each year; in 2002, 99,000 of these patients died as a result. In response, many state legislatures have passed laws requiring hospitals to publicly report rates of certain hospital-acquired infections. On the federal level, the Deficit Reduction Act of 2005 requires the Centers for Medicare and Medicaid (“CMS”) to deny payment for the added costs associated with certain, preventable hospital-acquired conditions. As a result, the device industry is faced with a unique opportunity to develop products that help hospitals increase their screening and testing of patients. Several such products such as rapid molecular assays and antimicrobial-coated devices, are already available and many others are expected to hit the market in 2008 and 2009. Additional information is available at www.thegraysheet.com (paid subscription service).
Medicare Device Provisions Still on the Table for 2008. Although Medicare was a hot topic for Congress in 2007, by year’s end, few policy changes were effected, leaving many issues up for debate in 2008. Despite heated debate on the topic, Congress passed a scaled back Medicare bill, which excludes many provisions that device firms lobbied for, as well as many they lobbied against. This means that many of the same issues addressed in 2007—such as, imaging cuts and comparative effectiveness legislation—will be addressed again in 2008. Top priorities for the medical device industry this year include: reimbursement for remote monitoring of devices and molecular diagnostics; charge compression; monitoring of CMS’ charge-with-evidence-development policy; competitive bidding for durable medical equipment; and gainsharing arrangements. Additional information is available at www.thegraysheet.com (paid subscription service).
For-Cause Inspections Reveal 10-Year High in Clinical Trial Violation Rate. The violation rate for sponsors of clinical trials reached a 10-year high in fiscal year 2007. Many of the violations were uncovered as a result of inspections triggered by complaints from industry competitors, clinical trial subjects, clinical investigators, and firm employees, to name a few. Insufficient monitoring of clinical sites was identified as the most frequent problem for trial sponsors in 2007. Other notable problems included failure to submit progress reports or obtain investigator compliance; hiring unqualified study monitors; and failing to receive appropriate Institutional Review Board (“IRB”) or Food and Drug Administration (“FDA”) approval before beginning a trial. Janice Hogan, a partner in the at the Washington, D.C., law firm Hogan & Hartson who represents medical device companies, attributes the increase in violations to higher expectations from FDA. According to the agency, a key factor for firms to consider when choosing clinical sites to work with is whether the site has well structured training programs or quality systems standard operating procedures. The agency believes that such programs will help reduce sponsor violations in the future. Additional information is available at www.thegraysheet.com (paid subscription service).
New Process to Help Device Firms Meet Regulatory Requirements. Asymtec and YESTech have developed a process by which medical device firms can more easily meet regulatory requirements imposed by the U.S. Food and Drug Administration (“FDA”) for traceability and validation in the manufacture of certain medical products. Specifically, the process combines the dispensing capabilities of Asymteck with the automated optical inspection technology of YESTech to validate that fluid droplets are accurately dispensed and correctly placed on medical devices, such as Lab-on-a-Chip devices, lateral flow test strips, and sensors, among others. Additional information is available at www.asymtek.com/applications/medical_device/default.htm.