CIMIT: August 2009 Regulatory Affairs Newsletter

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Industry Asks for Device-Specific Advertising Guidance. FDA guidance regarding risk information in drug and device promotional materials fails to account for the differences between drugs and devices, industry trade group AdvaMed told the agency in recent comments. The May 27, 2009 draft guidance outlines considerations that FDA takes into account when evaluating whether an advertisement is misleading, and it applies to devices restricted to use on the order of a health professional. AdvaMed says that conveying risk information for devices is different than drugs, as device risks are often influenced by surgical procedures in which the devices are used, not just the device alone.

FDA to Require More “522” Post-Approval Studies. FDA intends to impose additional post-marketing study requirements on certain device firms, agency staff said at a recent panel meeting. Under section 522 of the Federal Food, Drug, and Cosmetic Act, FDA can mandate post-marketing studies for certain higher-risk devices, and the agency now plans to use this authority to require “522 studies” from device firms who are failing to complete studies required as a condition of marketing approval. Failure to complete a 522 study results in misbranding of the device and possibly civil monetary penalties, product seizure, and prosecution.

FDA Guidance Aims to Increase Third-Party Inspections. Two FDA guidance documents issued in August may entice device firms to use third-party auditors more frequently for conducting quality system inspections of device facilities. One guidance document removes the requirement that companies get FDA approval prior to utilizing a third-party inspector, and the second guidance document outlines the accreditation criteria for such auditors. The third party inspection program has been in place since 2002 but has been underutilized since its inception.

FDA Proposes Electronic Adverse Event Reporting. On August 20, 2009, FDA proposed a draft regulation and accompanying draft guidance that would require device firms to submit medical device adverse event reports to FDA electronically. Device firms are required to submit reports of such events to FDA, but this has been done via paper forms in the past. Electronic reporting would save the FDA approximately $1.25 million annually and would save the device industry approximately $3.2 million annually. If the regulation is finalized, device firms would have one year after publication of the final rule before electronic reporting would take effect.

CMS Questions Quality of Lab-Developed Tests. The federal agency that oversees laboratory-developed molecular tests (“LDTs”) is concerned about the quality of such tests, according to an August 18, 2009 report by the Agency for Healthcare Research and Quality. The Center for Medicare and Medicaid Services (“CMS”), which has oversight of LDTs, is also concerned because the tests need only show analytical validity, rather than clinical validity or clinical utility, to be marketed under current standards. The report bolsters arguments from critics who assert that LDTs should be more stringently regulated, possibly by the FDA.

Assays, Masks Under Scrutiny as Flu Season Approaches. With the H1N1 strain of influenza A likely to strike again this year, the Centers for Disease Control (“CDC”) is evaluating the efficacy and utility of diagnostic flu tests and devices aimed at preventing the spread of the flu. In recent guidance, CDC noted that many current flu assays are not sensitive enough to rule out the H1N1 strain, thus the agency is looking to other recently developed tests for potentially accurate diagnoses. Additionally, the agency may revise its guidelines for masks and respirators worn by health workers to prevent flu spread, as evidence shows the devices are not amenable to everyday use.

FDA Device Center Director Resigns. Dr. Dan Schultz, who has directed FDA’s Center for Devices and Radiological Health (“CDRH”) for the past 15 years, announced his resignation on August 11, 2009. Schultz was considered friendly to the device industry and has been under considerable pressure from Congress and agency whistleblowers, who claim CDRH leaders have been too lax on industry and coerced staff into pro-industry decisions. Dr. Jeff Shuren, associate commissioner for policy and planning in the FDA commissioner’s office, will serve as acting CDRH director until FDA finds a permanent replacement.

Review of Preamendments Data Begins. In April, FDA called for device firms to submit data on 25 devices in circulation prior to the 1976 Medical Device Amendments, which established regulatory classes for medical devices. Now that the August 7, 2009 deadline for submission has passed, FDA is beginning “a great deal of review,” to assess whether the data support reclassifying these class III “preamendments” devices into lower-risk classification categories. FDA plans to assess the data, redact the submissions, and post the documents online while the agency is making decisions.

Industry Asks Supreme Court to Protect Patents for Diagnostics. Medical device industry groups have filed a brief in a pending Supreme Court case, Biliski v. Doll, which could determine whether diagnostic tests can be patented. In the case, the Court will decide whether a patentable “process” must either be tied to a machine/apparatus or be shown to transform something into another thing. If the Court accepts this definition of a patentable process, various diagnostic tests may not qualify for patent protection.

Senators Spar on Preemption for Devices. At an August 4, 2009 hearing, Democrats and Republicans argued over a bill proposing to eliminate protection for device firms from state lawsuits due to medical device injuries. The Medical Device Safety Act, proposed by congressional Democrats in March, would overturn a 2008 Supreme Court decision that insulated makers of devices approved through FDA’s premarket approval process from certain state lawsuits. Republicans and the device industry claim the bill will stifle innovation, while Democrats argue that it will improve patient safety.

Warning Letters to Come Faster, Hamburg Says. At a recent meeting, FDA Commissioner Margaret Hamburg detailed six steps the FDA will take to enhance enforcement of medical device regulations. One such step involves eliminating the requirement that FDA’s Office of Chief Counsel review all warning letters prior to sending the letters to firms that are in violation of various regulations. According to Hamburg, this will result in an increase in warning letters sent to device firms and more immediate action on the part of FDA for certain violations.

Comparative Effectiveness Budget Plans Detailed. The Agency for Healthcare Research and Quality (“AHRQ”) and the National Institutes of Health (“NIH”) both presented budgets to Congress on July 30, 2009, outlining how the agencies intend to spend the $700 million allocated to the two organizations for comparative effectiveness research. NIH is already reviewing applications for research funding, with the first funding decisions slated to be made this month. The AHRQ plans to spend the majority of its funds in 2010, most of which will ultimately produce comparative effectiveness data via research studies and registries.

Rapid Diagnostic Tests Could Reduce Hospital Infections. Screening incoming patients with rapid diagnostic tests could help to stem the tide of hospital infections and lower health care costs, public health experts and economists told congressional staff at a July 29, 2009 meeting. As many as 1.7 million infections are acquired annually in hospitals, resulting in 99,000 deaths and up to $33 billion in excess health care costs. As these infections grow resistant to antibiotics, it is increasingly important to prevent them from spreading throughout a hospital, experts say. Attendees at the meeting urged active surveillance, including routine cultures, rapid screening for antibiotic-resistant infections, and isolation of infected subjects to help reduce infections.

Experts Urge Caution in Informal Dialogue with FDA. Device firms engaging in informal discussion with FDA regarding marketing submissions must be aware of the limitations of this approach, device attorney John Smith noted in a July 22, 2009 web conference. FDA feedback during these dialogues can be incorrect, is non-binding on the agency, and can create misunderstandings on the part of the agency that can cause problems for a company in later reviews of marketing submissions. Smith advises utilizing informal discussions for simple, straightforward questions and employing the pre-IDE process whenever a company wants more reliable feedback from FDA.

Editorial Cites Challenges Facing Sentinel System. The Sentinel Initiative, FDA’s planned electronic postmarketing surveillance system for drugs and devices, must overcome serious hurdles before it will be viable, according to a July 27, 2009 editorial in the New England Journal of Medicine. Harvard professor Richard Platt and former FDA Commissioner Mark McClellan write in the editorial that a unique device identification system is needed before tracking of many medical devices is feasible. Additionally, the authors note that FDA must improve its processes such that it can determine more quickly if a device caused an adverse event or poses a health risk.

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