CIMIT: March 2010 Regulatory Affairs Newsletter

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Industry Weighs in on FDA Authority to Rescind 510(k)s. Device industry trade groups submitted comments last week to FDA regarding whether the agency has the authority to revoke 510(k) substantial equivalence determinations. Responding to an FDA request for public input on the issue, industry groups maintained that the agency would only be justified in rescinding a 510(k) if fraudulent means were used to establish substantial equivalence. As FDA reassesses its 510(k) program, one issue for the agency is its authority to nullify a prior 510(k) decision. While FDA law and regulations explicitly grant the agency the authority to withdraw a premarket approval application or investigational device exemption, no similar authority has been granted for 510(k) decisions.

GAO Report Encourages FDA to Focus on its Staff. In a report issued on March 23, 2009, the Government Accountability Office (“GAO”) urged FDA to develop a “human capital plan” to bolster the FDA workforce. GAO analyzed FDA’s recruitment, retention, and development of its workforce, through interviews with FDA officials and a survey of agency management. In its report, the GAO noted that while FDA has hired a significant number of new staff members in recent years and created incentives to attract top scientists, the agency does not have a strategic plan to coordinate its staffing efforts. FDA officials acknowledged that the agency needs to better educate its junior and mid-level staff, and the agency is now developing a human capital plan.

FDA Urges Quality Focus to Prevent Warning Letters. Jeffrey Shuren, the director of FDA’s device center, has called on device manufacturers to focus on their quality systems and take preventative actions to avoid problems with their products. According to Shuren, such preventative actions could reduce the number of warning letters from FDA, which many companies have found reduces their overall costs. FDA intends to focus on prevention of device problems in the coming years, Shuren said, because by the time a warning letter is issued, a problem already exists that the company should have addressed.

Industry, FDA Discuss Improving Transparency. Device industry representatives met with FDA Principal Deputy Commissioner Joshua Sharfstein recently to discuss methods for improving FDA’s transparency with regulated industries. FDA’s Transparency Task Force convened the meeting, at which device makers commented on the agency’s ability to communicate regulatory expectations to industry. Device industry trade groups AdvaMed and the Medical Imaging and Technology Alliance requested more input in guidance development, more timely posting of communications available for industry comment, and posting of all 510(k) decisions online.

Broadband Plan Seeks to Address E-Health Products. FDA and FCC should work together to clarify the regulatory scheme for devices that include both communications and health applications, according to the Obama administration’s National Broadband Plan. The plan, which was released March 16, notes that a lack of clarity over which agency should regulate such products could prevent innovation and adoption of such devices. As such, the administration asks that the two agencies seek public comment, hold stakeholder workshops, and jointly develop guidance on the issue. The plan also asks the Department of Health and Human Services to develop reimbursement incentives for such devices, to spur their use.

House Decides on Excise Tax for Device Sales. The health reform reconciliation bill passed by the House of Representatives on March 21 did ultimately include an excise tax on medical device manufacturers. After much debate, the final 2.3% tax is lower than expected, as the original reconciliation bill included a 2.9% tax. The tax would be assessed at the point-of-sale and would apply to all medical devices, aside from class I devices, eyeglasses, contact lenses, hearing aids, and devices generally purchased at retail outlets for personal use. Though small or start-up device firms are not exempt from the tax, device industry trade group AdvaMed said it still prefers the tax to other proposals considered during the health reform debate. Additional information is available at www.thegraysheet.com and www.wallstreetjournal.com (paid subscription service).

FDA Considering Tougher Regulation of Blood Glucose Meters. FDA recently held a public meeting regarding the clinical accuracy requirements for point-of care blood glucose meters, given increasing use of the devices outside the home. The meeting sought stakeholder feedback as to whether FDA’s criteria for the devices are stringent enough to ensure their accuracy when used in locations and for purposes for which they are not currently approved, such as in hospitals for achieving tight glycemic control of critically ill patients. Clinicians and researchers said the devices were not accurate enough to be used for insulin dosing decisions. FDA staff noted that a significant number of injuries and deaths have been linked to blood glucose monitors, increasing the likelihood that FDA will tighten regulatory standards for the devices.

FDA Seeking to Provide More Timely Updates. FDA is evaluating methods to enhance its communication with industry, according to Dr. Jeffrey Shuren, the director of FDA’s device center. Specifically, the agency is looking for ways to apprise industry of changing regulatory standards more quickly. Though FDA has typically issued guidance or adopted consensus standards to provide industry with the agency’s regulatory expectations, the agency feels these processes are too time-consuming and cumbersome. Shuren noted that the agency may employ a variety of communication tools on a continuum, such that first the agency issues a quick notice to industry, then develops guidance, then develops a standard.

New Human Factors Standard to be Issued Next Month. The Association for the Advancement of Medical Instrumentation plans to issue a new consensus standard for medical device development in April, which will help companies take human use of the device into account when designing devices. The standard was developed in close collaboration with FDA and seeks to address human factors engineering, a hot button topic in recent years as FDA has found that many device failures are due to user error. The standard, called HE-75, builds on recent FDA guidance and will include a section on managing the risk of user error, which will be important for new devices undergoing premarket review.

Sunshine Provisions Seem Set in Stone. According to Capitol Hill staff, provisions of the health reform bill that require disclosure of payments from industry to health professionals likely will not change during ongoing health reform negotiations. The provisions, often referred to as the “sunshine” provisions, would require companies to disclose payments to physicians or teaching hospitals in the amount of $10 or more. Some portions of the health reform bill could be modified during the budget reconciliation process Democrats intend to use to pass the bill. However, only changes that directly impact the federal budget can be made during that process, and the sunshine provisions do not directly impact the budget.

Industry Comments on FDA Use of New Science in Device Regulation. Device firms have commented to FDA on the agency’s plan to improve its use of new, emerging science in the regulation of medical devices, following a recent public workshop on the topic. Industry trade groups asked FDA to better define “new science,” and noted that some information—for example, adverse event reports—may not qualify as valid scientific evidence until the information is scientifically analyzed. Industry representatives also asked the agency to issue guidance as soon as a change to regulatory standards has been made on the basis of new science. Trade groups also cautioned that FDA should consider the effect on pending marketing applications and clinical trials, when the agency changes its opinion of valid scientific standards for a given device type.

IOM Holds First Meeting Regarding 510(k) Program. As part of its effort to assess the public health effectiveness of the 510(k) program, FDA has commissioned a review of the program by the Institute of Medicine (“IOM”). In its first meeting on March 1, 2010, the IOM committee members questioned the use of old or inferior predicates by companies submitting new 510(k)s. Additionally, the committee expressed concern that device firms can make incremental modifications to a cleared device or its labeling, saying it seems firms have “free rein” to change labeling without notifying FDA. Finally, the IOM discussed the third-party review for 510(k)s, questioning its efficacy and noting its current limitations.

Device Firms Urge Restraint in Regulation of Internet Content. Recently, FDA requested stakeholder feedback on the regulation of Internet advertising and promotion for drugs and devices, given the rise of social networking sites such as Facebook, Twitter, and YouTube. In comments to the agency, device firms are urging the agency to hold companies responsible only for Internet content that the company controls. As many Internet users can generate their own content about drugs and devices via blogs, chat rooms, and social networking sites, industry trade groups feel it is unreasonable for device firms to be held responsible for such content. Overall, many groups are asking that the agency provide new guidance or regulations on Internet promotion, to aid companies in compliance.

ODE Director Leaving FDA this Month. Donna Bea-Tillman, the director of the Office of Device Evaluation (“ODE”) at FDA’s Center for Devices and Radiological Health, is leaving the agency on March 26, 2010 to join the private sector. Tillman spent 15 years in ODE, the office that conducts premarket reviews of medical devices. Though well-liked by industry and the regulatory community, Tillman came under pressure in recent years when ODE whistleblowers sent letters to Congress alleging that the device review process had become too lenient on industry. After leaving FDA, Tillman will run the regulatory and policy department at Microsoft’s health group.

FDA, NIH to Improve Evaluation of New Technologies. FDA has partnered with the National Institutes of Health (“NIH”) to identify new methods for evaluating the safety and efficacy of medical technologies. The collaboration seeks to advance regulatory science to keep pace with emerging technologies, so that outdated review methods at FDA do not delay approval of novel drugs and devices. Under the partnership, the agencies will award $6.75 million in grants from 2011 through 2013, to support research into improved tools and methods for evaluation. The collaboration will also result in a joint FDA-NIH leadership council, which will seek to ensure that FDA regulatory concerns are appropriately taken into consideration when planning NIH-funded research.

FDA Moves to Regulate Health Information Technology Software. In testimony on Capitol Hill last week, Jeffrey Shuren, the director of FDA’s device center, stated that the agency considers health information technology (“HIT”) to be a medical device. As such, FDA would have the authority to regulate HIT software systems and could require HIT software systems to undergo pre-market review by FDA. Though Shuren did not identify the approach FDA would take to regulating such devices, his statements indicate the agency may be looking to regulate these products in the near future. The testimony follows a letter sent to the Secretary of Health and Human Services, in which Sen. Chuck Grassley (R-Iowa) inquired as to the role of FDA and HHS in reviewing HIT systems.

FDA Formulating Guidance on Companion Diagnostics. After a concept paper published in 2005 drew criticism from industry, FDA intends to publish guidance this year on the co-development of diagnostic devices and drugs. In recent years, industry has expressed interest in co-developing drugs and devices to allow for personalized medicine, whereby patients’ individual responses to various drugs could be evaluated and utilized to develop optimal treatment. FDA has sought to address this topic in the past, but has struggled with developing a clear policy. The new guidance should address clinical trial requirements for co-developed drugs and devices and is expected to facilitate coordination of the FDA drug and device center in regulation of such products.