Senate Halves Device Industry Fee in Revised Bill.  On November 18, 2009, the Senate released its consolidated health care reform bill, which reduced the proposed device industry fee from $40 billion over ten years to $20 billion over ten years.  The fee, first proposed in a health reform bill from the Senate Finance Committee, is one of many taxes on health-related industries that will help to fund health reform. Device industry trade group AdvaMed supported the $20 billion fee, though the group would prefer to see some additional changes.  The bill also included a surprising provision that would charge a 5% tax on all elective cosmetic procedures.  The provision could affect device firms that produce dermal fillers, bariatric surgery devices, and other devices used in cosmetic procedures.  Additional information is available at www.thegraysheet.com (paid subscription service).

Risk Communication Committee Issues Recommendations.  FDA’s Risk Communication Advisory Committee has submitted its recommendations to the agency for communicating risk information to the public quickly and effectively.  The Committee made six key recommendations, which included creating a consistent policy for communicating information about emerging risks and using standardized formats for communicating risk messages.  The group emphasized that risk communications should address the nature of the risks and benefits of the regulated product at issue, as well as the evidence indicating that a risk is associated with that particular product.  Additional information is available at  www.thegraysheet.com (paid subscription service).

Digital Mammography 510(k)s May Require Clinical Data.  According to FDA’s Radiological Devices advisory panel, the agency should require clinical data for some 510(k) submissions for full-field digital mammography devices.  At FDA’s request, the panel was convened to aid the agency in devising a guidance document for full-field digital mammography.  The panel’s recommendations urge FDA to require clinical data in 510(k) submissions for new digital products that substantially change or improve breast cancer images compared with current technology.  Clinical data should not be required, however, for new digital mammography devices whose features and technology largely resemble currently marketed products.  Additional information is available at  www.thegraysheet.com (paid subscription service).

Court Upholds Civil Money Penalty for Failure to Report MDRs.  A federal appeals court recently upheld a ruling requiring a medical device firm to pay a hefty civil money penalty to FDA because the firm failed to file medical device reports (“MDRs”) in keeping with FDA regulations.  Per the regulations, companies are required to report adverse events related to their devices by filing MDRs.  Under the Safe Medical Devices Act of 1990, FDA can impose civil money penalties on firms for failing to file MDRs, but the recent court case marks the first time the agency has imposed such a penalty.  Analysts say the ruling may encourage the agency to pursue similar penalties in the future.  Additional information is available at www.thegraysheet.com (paid subscription service).

Transparency Task Force to Address Industry Concerns.  In recent months, the new FDA Transparency Task Force has conducted public meetings and created a blog in an effort to increase understanding of the agency’s processes and methods.  Throughout this process, the Task Force found that industries regulated by FDA also have numerous questions about the agency’s inner workings and certain ambiguous rules.  As a result, the Task Force is dividing its efforts into a three part initiative, the third of which will be called the “Transparency for Regulated Industry” initiative and will address industry concerns and questions.  Additional information is available at  www.thegraysheet.com (paid subscription service).

Supreme Court Considering Cases Affecting Diagnostic Test Patents.  On November 9, 2009, the Supreme Court heard oral arguments in a case that could affect whether makers of diagnostic tests would be able to patent such tests.  Device industry trade group AdvaMed contends that gene assays predicting a patient’s response to a drug, or a test for a protein or biomarker associated with disease, would not be patent eligible if the Court upholds a lower court ruling in the case.  The Court also is considering whether to grant review in a similar case involving a patent for a test that measures drug metabolites in the blood to aid in drug dosing.  Additional information is available at  www.thegraysheet.com (paid subscription service).

Task Force Debates Release of Information on Unapproved Products.  FDA’s Transparency Task Force is trying to decide whether, in certain cases, the agency should publicly disclose information about products whose approval applications have been withdrawn or are still under review.  At a November 3, 2009 meeting, the Task Force discussed releasing information when applications are withdrawn due to safety concerns, or when firms publish overly optimistic information during a product review.  No consensus was reached on either issue, though the Task Force plans to produce recommendations by December or January for improving transparency at FDA.  Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Publishes Guidance on Emergency Use of H1N1 Diagnostics.  On November 2, 2009, FDA issued a guidance document outlining how manufacturers may obtain authorization to market unapproved tests for diagnosing the H1N1 virus.  FDA may authorize emergency use of unapproved devices in certain situations, including a public health emergency.  Since the H1N1 swine flu epidemic was declared a public health emergency in April, the agency has authorized emergency use of seven H1N1 diagnostic tests.  The new guidance provides a template for other device firms looking to qualify for an emergency use authorization.  Additional information is available at  www.thegraysheet.com (paid subscription service).

Lawsuit Continues Over Patenting of Breast Cancer Genes.  A lawsuit filed in May challenging the patenting of the BRCA1 and BRCA2 breast cancer genes has been allowed to proceed, in a November 1, 2009 ruling by a federal judge in New York.  The lawsuit alleges that patenting the genes will restrict scientific research and limit access to breast cancer genetic testing, because patients could only be tested by labs owned by the company holding the patent.  The plaintiff groups also contend that patenting the genes is unconstitutional in that the patent owner would have ownership over products of nature and natural phenomena.  Additional information is available at  www.thegraysheet.com (paid subscription service).

National Registry, UDI System Proposed in Health Reform.  The House of Representatives health care reform bill, which may be put to a floor vote this week, includes provisions requiring medical device firms to submit certain information to a national medical device registry.  Under the bill, firms would have to submit to the registry postmarket safety data and identifying information for their devices.  The registry seeks to link all sources of postmarket safety information regarding a device with that specific device.  The bill also requires FDA to issue a proposed rule for a unique device identifier system within six months of the bill being signed into law.  Additional information is available at www.thegraysheet.com (paid subscription service).

FDA to Close Loophole for Study Investigators.  FDA will revise its clinical investigation regulations, after a report from the Government Accountability Office identified a loophole whereby clinical investigators who are prohibited from participating in certain clinical trials can still oversee other trials.  The loophole allowed clinicians who were disqualified by FDA from participating in drug studies, for instance, to lead medical device studies, because these studies evaluate a different type of investigational product.  The agency typically disqualifies investigators from clinical trial participation for submitting false information to the agency or trial sponsor, or for repeatedly or deliberately failing to follow applicable regulations.  Additional information is available at  www.thegraysheet.com (paid subscription service).

House Health Reform Bill Reduces Device Tax.  After targeted lobbying by the medical device industry, the health reform bill released last week by the House of Representatives proposes a lower device industry tax than has been proposed in similar bills in the Senate.  Both the House and Senate bills propose to fund health care reform in part by taxes on health-related industries, including the device industry.  The House bill suggests a $27 billion tax on the device industry, to be paid over the course of six years, while the key Senate bill has proposed a $40 billion tax to be paid over ten years.  The Senate bill also includes some protections for smaller device firms, however, which were not included in the House bill.  Additional information is available at  www.thegraysheet.com (paid subscription service).