CIMIT: May 2009 Regulatory Affairs Newsletter

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Obama Memo Seems to Reject Preemption. In a May 20, 2009 policy memo, the Obama administration implied that it supports current congressional efforts to overturn the ban on state lawsuits for injuries caused by certain medical devices. In 2008, the Supreme Court ruled that devices approved through the premarket approval (“PMA”) process were protected from state law suits tied to device-related injuries, under the doctrine of preemption. Congress is debating legislation that would overturn the Supreme Court ruling. The May 20 memo indicates that if the legislation passes, President Obama will sign it into law.

New FDA Leaders Will Look Into 510(k) Process. In hearings before Congress last week, new Deputy FDA Commissioner Joshua Sharfstein said that both he and Commissioner Margaret Hamburg will review the 510(k) clearance process as a whole to determine if it is functioning appropriately. Sharfstein noted that FDA may need to be more transparent in its 510(k) decisions, as much of the recent controversy surrounding the 510(k) review process may stem from a sense that the reviews are conducted behind closed doors.

Vermont May Institute Device Firm Disclosure Rules. Vermont’s state legislature has passed a bill that requires device firms to disclose all payments made to physicians and bans gifts to physicians, and the state’s governor is expected to sign the measure into law. Vermont would be the second state to institute such rules, following in the footsteps of Massachusetts, which instituted similar rules in March of this year. Texas, New York, and Minnesota are considering similar rules, prompting concern from the device industry that it will have to comply with a variety of laws that differ by state.

FDA Performs Internal Review of a 510(k) Clearance. After controversy surrounding the 510(k) clearance process in general, and the clearance of ReGen Biologics’ Menaflex knee repair device in particular, FDA is performing a rare internal review into the clearance of the Menaflex device. The review will evaluate the agency’s decision-making process during the 510(k) review of the device, which could potentially lead to a “reconsideration” of the device clearance. The internal review follows allegations of potential congressional lobbying of FDA to clear the device and a letter from Sen. Chuck Grassley (R-Iowa) requesting information regarding FDA’s clearance of the device.

CMS Refuses to Cover CT Colonography. In a May 12, 2009 decision memo, the Centers for Medicare and Medicaid Services (“CMS”) refused to provide reimbursement through Medicare for CT colonography, a procedure for colorectal cancer screening that is quicker and less invasive than current colonoscopy methods. Device firms producing imaging equipment called for a re-opening of the rulemaking process to consider new data on the procedure, while the American College of Radiology has asked Congress to pass legislation mandating coverage for the procedure.

Office of Health Reform Leaders Appointed. On May 11, 2009, the leaders of the new Office of Health Reform within the Department of Health & Human Services (“HHS”) were named by HHS Secretary Kathleen Sebelius. The Office was established by an executive order issued by President Obama in April 2009. Jeanne Lambrew, a health policy expert from the Obama administration, will lead the Office, along with HHS Senior Advisors Michael Hash and Neera Tanden.

Obama Requests Budget Increase for FDA Device Center. In its fiscal year 2010 budget request sent to Congress on May 7, 2009, the Obama administration requested a $35 million funding increase for FDA’s Center for Devices and Radiological Health (“CDRH”). The additional funds would increase CDRH’s budget by 12.5% and would be used to hire 113 additional employees, increase manufacturing inspections, and develop guidance for industry. The increase comes as part of a general 15% funding increase for FDA proposed by the Obama administration.

FDA Revising Training Program for Device Reviewers. The Office of Device Evaluation (“ODE”) at FDA is modifying its training program for reviewers of device approval and clearance applications, to increase the emphasis on 510(k) reviews. Device industry critics often contend that new reviewers request information in 510(k) notices that is not necessary to show substantial equivalence and is not in keeping with FDA’s mandate to use the “least burdensome” approach to device reviews. ODE says the new program will add more specific training materials on 510(k)s and include a new “24/7” online training system.

Hamburg Outlines Goals, Discusses Device Reviews at Confirmation Hearing. President Obama’s nominee for FDA Commissioner, Margaret Hamburg, discussed her top priorities at her May 7 confirmation hearing before the Senate Health, Education, Labor, and Pensions Committee. Hamburg said that she would focus on technological innovation and post-market monitoring during her tenure at FDA. When asked about controversy surrounding whistleblower allegations of coercion in device reviews at FDA, Hamburg said she was concerned about the allegations and that she would instill a new culture at the agency where scientists feel free to raise issues without fear of retaliation.

Swine Flu Prompts Rush for Effective Diagnostic Tests. Since the declaration of a national public health emergency due to swine flu, both FDA and the device industry have been busy trying to provide devices necessary to contain the outbreak. Under a 2004 law, FDA authorized emergency use of an unapproved swine flu diagnostic test that can produce results in as little as four hours. The test is not portable, however, prompting industry to scramble to produce rapid testing tools that could effectively diagnose the H1N1 strain in the field.

Device Reps Should Have More Access to Doctors, IOM Says. An April 28, 2009, Institute of Medicine (“IOM”) report found that while conflicts of interest remain a concern, device industry representatives may need more access to clinicians than drug industry representatives, because device representatives are involved in more significant medical education activities. The report still recommends prohibitions on gifts from industry to clinicians, educational programming controlled by industry, unwritten consulting arrangements, and other policies to prevent conflicts of interest from arising.

FDA Drafting QSR Guidance for Clinical Labs. FDA currently is devising guidance aimed at helping clinical laboratories comply with the quality system regulation (“QSR”). Historically laboratory-developed tests have not been regulated by FDA, and have not needed to comply with the QSR, prompting industry to question whether FDA is seeking to regulate such tests via the guidance. The drafters contend that the guidance is not requiring labs to comply with the QSR, but merely outlining how to do so if a laboratory is interested.

FDA’s New Risk Communication Plan Should Involve Industry. On April 15, 2009, FDA issued a draft risk communication plan outlining the agency’s strategy for improving communications regarding product risks. Device industry trade group AdvaMed says that the plan should involve industry to a greater degree, as the agency historically has not involved industry in these communications. AdvaMed identified specific strategies in the plan that present opportunities for agency-industry partnership and presented its suggestions at an April 30, 2009, panel meeting regarding the plan.

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