CIMIT: February 2008 Regulatory Affairs Newsletter

February 2008 Regulatory Affairs NewsletterPrint this page

• New Combination Products Chief Named
• FDA Proposed Rule Would Relax Restrictions on Off-Label Promotion
• Draft HHS Regulation Offers Discreet Adverse Event Reporting
• New Guidance Documents Released
• President’s FY 2009 Budget Would Cut Ten CDRH Staff Positions
• CMS Again Considers Carotid Artery Angioplasty Coverage Decision
• CryoLife Receives 510(k) Clearance for Pulmonary Heart Valve
• CAD Advisory Panel to Meet in March
• FDA Technology Update Underway; More Funding Needed
• Motivation for FDA’s Off-label Promotion Guidance Investigated
• FDA Releases Final CLIA Waiver Guidance; Industry Reacts
• FDA Releases Medical Glove Guidance Manual
• CMS Looks to National Oncologic PET Registry as Model for Imaging Coverage
• FDA Seeking Comments on Small Business Qualifications
• St. Jude’s QuickFlex Leads Receive FDA and CE Mark Approval
• BayBio Calls for Federal Reforms

New Combination Products Chief Named
On January 6, 2008, Thinh Nguyen took over as the new director of the Food and Drug Administration's ("FDA" or "the agency") Office of Combination Products ("OCP"), after 14 years at the Center for Devices and Radiological Health ("CDRH"). Industry leaders are now looking to Nguyen to issue long awaited proposed rules on good manufacturing practices ("GMP") and adverse event reporting for combination products. The proposed rule on combination product GMPs is expected to give the manufacturers of combination products flexibility in deciding whether to comply with the drug cGMP regulations or the device quality system regulations ("QSR") to avoid having to fully implement both. In addition, a concept paper on cross-labeling, a clear definition of "chemical action," and a new guidance on contrast agents are expected to be released by OCP in the coming year. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Proposed Rule Would Relax Restrictions on Off-Label Promotion
The Food and Drug Administration ("FDA" or "the agency") recently proposed a new guidance that would allow medical device manufacturers to provide physicians with medical journal articles addressing the off-label uses of their products. Although companies would have to include prominent warnings that the uses discussed in the articles are not FDA-approved, companies would essentially be permitted to promote their products for off-label uses. Many health care professionals and device industry leaders are encouraged by this rule and believe that it will contribute to the practice of medicine by immediately supplying relevant information about the potential benefits of a certain product to physicians. However, others are skeptical, suggesting that this new guidance will create a conflict of interest for companies and may result in unsafe product use. The agency will be accepting public comments on the proposed guidance for 60 days. Additional information is available at www.medicalnewstoday.com/articles/97909.php.

Draft HHS Regulation Offers Discreet Adverse Event Reporting
The Department of Health and Human Services ("HHS") recently proposed a regulation implementing the Patient Safety and Quality Improvement Act of 2005's provisions calling for the creation of patient safety organizations ("PSO"). PSOs would be certified by HHS, allowing them to contract with hospitals to confidentially accept patient safety information. The law, which is intended to provide health care providers a venue for adverse event reporting without fear of lawsuits or professional sanctions, would allow voluntary reporting of safety information to PSOs under a legally binding non-disclosure agreement. However, the rule specifically lists the U.S. Food and Drug Administration ("FDA" or "the agency") as an exception to the confidentiality rules. Public comments are currently being accepted regarding whether the regulation should also exempt communications to device and drug companies that rely on such reports to fulfill their FDA
reporting requirements. Additional information is available at www.thegraysheet.com (paid subscription service).

New Guidance Documents Released
The Food and Drug Administration ("FDA" or "the agency") recently added two new guidance documents to the Center of Devices and Radiological Health ("CDRH") website. One describes the agency's expectations for premarket notification
("510(k)") submissions for coronary and carotid embolic protection devices and is available at http://www.fda.gov/cdrh/ode/guidance/1658.html. The other is a draft guidance that sets forth the agency's recommendations for analytical and clinical performance studies to support premarket submissions for in vitro diagnostic devices intended for the detection or detection and differentiation of influenza viruses. This document is available at http://www.fda.gov/cdrh/oivd/guidance/1638.html.

President’s FY 2009 Budget Would Cut Ten CDRH Staff Positions
Although President Bush’s proposed budget for FY 2009 would appropriate approximately $7 million more to the U.S. Food and Drug Administration’s (“FDA” or the “agency”) device center (“CDRH”)over the FY 2008 budget, the proposal would also cut approximately ten CDRH staff positions. The additional funds represent a small cost of living increase and a small increase in device import oversight spending. According to the proposal, approximately $1.4 million saved through FDA’s modernization efforts are being directed away from CDRH to fund other, higher priority initiatives. Overall, the budget allocates $290.9 million for device related activities—$241.9 of which will come from Congressional appropriations and $49 million will come from industry user fees. Additional information is available at www.thegraysheet.com (paid subscription service).

CMS Again Considers Carotid Artery Angioplasty Coverage Decision
At the request of physicians groups, the Center for Medicare and Medicaid Services (“CMS”) is reopening its coverage decision on carotid artery angioplasty. Physicians’ groups argue that the current policy denies adequate medical care to some patients who need the procedure, such as those for whom other types of interventions are not feasible. CMS will accept public comments on the issue until March 2, 2008. The agency is scheduled to release a proposed decision memorandum by August 1, 2008. Additional information is available at www.thegraysheet.com (paid subscription service).

CryoLife Receives 510(k) Clearance for Pulmonary Heart Valve
FDA recently cleared CryoLife’s CryoValve SG pulmonary heart valve, which is processed with the company’s proprietary SynerGraft technology. The device is free of allogenic cells and cellular remnants from the donor and is indicated to replace diseased, damaged, malfunctioning, or malformed pulmonary valves. According to CryoLife, the device can also be used in conjunction with right ventricular outflow tract reconstruction procedures in children. Additional information is available at www.fdanews.com.

CAD Advisory Panel to Meet in March
FDA announced in a February 7, 2008, Federal Register notice that its Radiological Devices Panel will meet on March 4–5, 2008, to discuss and make recommendations concerning computer aided detection and diagnosis (“CAD”) devices for use with radiological images. The panel will evaluate how the technology is currently being used and how the agency should assess CAD devices. Specifically, the panel will focus on what safety and effectiveness data will be required by the agency in future premarket submissions for these devices. Additional information is available at www.thegraysheet.com.

FDA Technology Update Underway; More Funding Needed
On January 29, 2008, FDA Commissioner Andrew von Eschenbachstated during a congressional hearing that the agency’s information technology (“IT”) infrastructure is flawed and that it impedes FDA’s ability to effectively monitor drug and device safety. According to von Eschenbach, when he arrived at FDA in 2006, the IT systems and equipment were operating at only 30 percent efficiency. The Commissioner claims that he has worked to rejuvenate the system and that he has a plan to completely modernize it over the next two years. However, critics suggest that FDA’s modernization plan is moving too slowly and that the agency’s current IT systems are problematic and potentially dangerous. Additional information is available at www.thegraysheet.com (paid subscription service).

Motivation for FDA’s Off-label Promotion Guidance Investigated
Representative Henry Waxman (D-Calif.) is investigating FDA's motivation for proposing a draft guidance that would allow medical device and drug companies to disseminate journal articles discussing off-label uses of their products without facing federal prosecution for off-label promotion. In a January 22, 2008, letter, Waxman questioned the agency’s reluctance to provide documentation surrounding its decision and suggests that the agency’s motivations for the proposal were largely to protect companies from prosecution, not to advance the public health. Waxman’s letter can be viewed at http://oversight.house.gov/documents/20080122141935.pdf. Additional information is available at www.fdanews.com.

FDA Releases Final CLIA Waiver Guidance; Industry Reacts
FDA recently released a new guidance entitled, Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices, available at http://www.fda.gov/cdrh/oivd/guidance/1171.pdf. CLIA-waived diagnostic tests may be sold to a large subset of laboratories, whose personnel and facilities are subject to the lowest level of government oversight. Although the agency’s final guidance is less restrictive than what FDA originally proposed, industry is not satisfied with the guidance and claims that its requirements are too prescriptive and will force companies to perform studies beyond what Congress intended when it passed CLIA in 1988. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Releases Medical Glove Guidance Manual
On January 22, 2008, the Food and Drug Administration (“FDA”) released a new guidance document, Guidance for Industry and Staff – Medical Glove Guidance Manual, which supersedes the agency’s prior guidance on the topic. The new guidance, which includes suggested formats for premarket notification (“510(k)”) submissions for various types of medical gloves, can be viewed at http://www.fda.gov/cdrh/ocer/guidance/1661.pdf.

CMS Looks to National Oncologic PET Registry as Model for Imaging Coverage
The Centers for Medicare and Medicaid Services (“CMS”) will likely use its 2005 national coverage policy for positron emission tomography (“PET”) as a model for coverage policies for other diagnostic imaging technologies. That policy established a National Oncologic PET Registry and required enrollment in clinical studies for certain cancer indications. Now, the Academy for Molecular Imaging, the sponsor of the NOPR, has asked CMS to expand the registry to allow coverage-with-evidence-development (“CED”) for PET for a number of conditions, rather than maintaining the agency’s proposed national noncoverage policy for those conditions. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Seeking Comments on Small Business Qualifications
The U.S. Food and Drug Administration (“FDA”) is seeking feedback from the public regarding its new information requirements for foreign companies seeking small business status pursuant to the Food and Drug Administration Amendments Act of 2007 (“FDAAA”). The new requirements allow certain foreign businesses to qualify for reduced medical device user fees, even though they do not file tax returns in the United States. Such businesses can submit a certification form, in English, from their national taxing authorities detailing certain financial information about the company. Comments on the collection of this information can be submitted to www.regulations.gov or www.fda.gov/dockets/ecomments. Additional information available at www.fdanews.com.

St. Jude’s QuickFlex Leads Receive FDA and CE Mark Approval
St. Jude Medical recently announced that it has received both FDA and European CE Mark approval for its QuickFlex family of left-heart leads for the treatment of heart failure. The devices, which feature a short tip and ring electrodes, are used in cardiac resyncronization therapy (“CRT”). The shorter electrode is intended to help physicians to maneuver the lead through the bends in the heart’s venous system that are characteristic of the left side of the heart. The QuickFlex devices are designed for use with St. Jude Medical’s heart failure devices. Additional information available at www.medicalnewstoday.com.

BayBio Calls for Federal Reforms
BayBio, a northern California life sciences industry coalition, recently presented a report warning that current government policies are threatening innovation in the field of biotechnology. The January 23, 2008, report calls for federal and state policy changes, including more National Institutes of Health (“NIH”) funding; Centers for Medicare and Medicaid Service reforms; and $175-million in additional FDA appropriations for fiscal year 2009. The group’s goal is to combine additional people with new technology and faster review times to get cutting edge products to patients faster. Additional information is available at www.thegraysheet.com (paid subscription service).