CIMIT: April 2009 Regulatory Affairs Newsletter

April 2009 Regulatory Affairs NewsletterPrint this page

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Congress Seeks Review of Device Approval Process. A bill recently introduced in the Senate would require the Institute of Medicine (“IOM”) to evaluate FDA’s process for clearing and approving medical devices. Senators Chuck Grassley (R-Iowa) and Ted Kennedy (D-Mass.) introduced the bill April 23, 2009, urging the IOM review due to recent allegations of coercion in the medical device clearance and approval process. According to the bill, the IOM would evaluate both the 510(k) and PMA process, and identify strengths and weaknesses in FDA’s review of device submissions.

Warning Letters Likely for Violations of ASR Regulation. At a recent conference, FDA officials noted that inspections of diagnostic test firms have revealed numerous violations of a key regulation, which may result in warning letters to the violators. Acting director of FDA’s Office of In Vitro Diagnostics, Don. St. Pierre, said many firms are selling complicated diagnostic tests as 510(k)-exempt analyte-specific reagents (“ASRs”). ASRs, which are simple components of a diagnostic test, can be sold without a 510(k) clearance to laboratories or device firms to be made into diagnostic tests. However, more complex test components or diagnostic products require 510(k) clearance prior to marketing.

Device Firms to Publicly Report Adverse Events. By September 2009, device manufacturers must begin posting adverse event data on the National Institutes of Health’s database ClinicalTrials.gov. Under the FDA Amendments Act of 2007 (“FDAAA”), device firms must add to the public database information on serious adverse events and frequent adverse events that have occurred in their clinical trials. Device industry opponents say the FDAAA provision was intended for drug companies, rather than device companies.

Intended Use Renders Software Medical Device. According to FDA software compliance expert John Murray, any software could be considered a medical device if it meets the statutory definition of a medical device, as FDA will consider anything a medical device if its intended use meets this definition. For example, electronic devices such as PalmPilots could be considered medical devices if sold with software that is for medical management of a disease.

Sebelius Answers Senators’ Additional Questions. Kathleen Sebelius, President Obama’s nominee for Health and Human Services (“HHS”) Secretary, showed support for imaging reforms in written responses to additional questions from Senators following her confirmation hearings. Sebelius indicated that she would support prior authorization of imaging scans by radiology benefit managers to curb utilization of such scans. Yet Sebelius may not support the Physician Payments Sunshine Act, which would require drug and device companies to publicly report relationships with physicians. When asked about comparative effectiveness research, Sebelius was somewhat vague as to her feelings on treatment cost comparisons.

Competitive Bidding Rule for Certain Devices Takes Effect. Despite objections from suppliers of durable medical equipment, prosthetics, orthotics and supplies (“DMEPOS”), CMS implemented a competitive bidding program for DMEPOS on April 18, 2009. Congress approved the competitive bidding program in 2003, replacing the fee-schedule based payment system that CMS previously used for these devices and supplies. The program was supposed to be implemented January 16, 2009, but was delayed to allow further review by CMS of claims that the bidding system would put small suppliers out of business.

Device Groups Seek to Preserve Preemption. On March 31, 2009, a coalition of 18 device industry groups, including AdvaMed and the Medical Device Manufacturers Association, sent a letter to congressional leaders urging them not to overturn a 2008 Supreme Court case that limits state lawsuits due to injury from medical devices. The letter noted that the Supreme Court preemption ruling only restricts lawsuits related to devices approved via the premarket approval (“PMA”) pathway, which represents 2% of devices on the market. Additionally, the groups argued that overturning the preemption ruling would disincentivize device firms from developing PMA devices, ultimately harming public health.

FDA Requests Data on 25 Pre-Amendments Device Types. In response to the January 15, 2009, report by the Government Accountability Office (“GAO”), FDA recently issued an order requiring that the manufacturers of 25 pre-amendment device types submit safety and effectiveness summaries to the agency so that FDA can determine whether these devices should be downclassified. The devices in question, which include intra-aortic balloon systems, implantable pacemaker pulse generators, automated external defibrillators, and small screw spinal systems, among others, were grandfathered into the class III category and have never been formally reclassified. FDA is requiring that companies comply with the order by August 7, 2009. Failure to do so may result in charges of misbranding, seizure, injunction, or civil or criminal penalties.

UDIs May Influence Reimbursement Policies. According to health policy analysts, the Centers for Medicare and Medicaid Services (“CMS”) may utilize device-specific information obtained through the use of unique device identifiers (“UDIs”) to determine inpatient diagnosis-related group payment rates and to adjust Medicare coverage decisions in the coming years. FDA is expected to issue a proposed rule establishing a UDI system to track medical devices throughout their distribution cycle before the end of the year. Analysts expect that CMS will introduce a UDI policy in its upcoming inpatient rulemaking process.

FDA Requests International Joint Replacement Data. FDA is seeking to obtain international joint replacement device data, including data on artificial hips, knees, ankles, and other joints, which would allow the agency to conduct an independent analysis of implant duration, survival, adverse events, and revision rates. The agency has expressed interest in collaborating with non-U.S. registries to collect data on devices that have a minimum 80% response rate for at least 1,000 patients followed for five or more years.

Whistleblower Letters Released. Sen. Chuck Grassley (R-Iowa) released two letters written by FDA whistleblowers at the recent confirmation hearings Gov. Kathleen Sebelius, President Obama’s nominee for Health and Human Services (“HHS”) Secretary. One letter, written to President Obama on April 2, 2009, and signed by nine whistleblowers whose names were redacted, was written on letterhead from the Office of Device Evaluation and claimed that devices have been approved or cleared by the agency in violation of the law and FDA regulations. The second letter, written directly to Sen. Grassley, urged him to make the nominee for HHS Secretary aware of the ongoing problems at FDA.

Consumers Urge Congress to Allow Device Suits. Consumer groups took to Capitol Hill last week to encourage passage of a bill that would allow lawsuits against device manufacturers for injury due to medical devices. The Medical Device Safety Act, introduced March 5, 2009, would overturn the Supreme Court’s 2008 ruling in Riegel v. Medtronic, which restricted personal injury lawsuits against medical device manufacturers in state court. On March 31, 2009, a coalition of 40 advocacy groups brought 19 patients injured by medical devices to Capitol Hill to tell their stories, urging Congress to pass the Medical Device Safety Act before the summer recess.

AdvaMed Creates Plan for IVDs and LDTs. Device-industry trade group AdvaMed has submitted to FDA a plan for revamping regulation of in vitro diagnostic tests (“IVDs”) that allows for FDA oversight of laboratory-developed tests (“LDTs”). The plan proposes regulation of the products based on a tiered system that reflects the risks associated with the device, the novelty of the technology and biomarkers used, and the training level of the intended operator of the test. The plan also proposes potential FDA review of LDTs, which previously have not been regulated by FDA, but which must comply with the Clinical Laboratory Improvement Amendments of 1988.

Additional information on these topics is available at www.thegraysheet.com (paid subscription service).