News: January 09, 2008

ClinicalTrials.gov Certification to Accompany Premarket Submissions.  The Food and Drug Administration Amendments Act of 2007 (“FDAAA”) requires that additional information be submitted to the clinical trials data bank, www.ClinicalTrials.gov, including information about and results of qualifying clinical trials.  One new provision requires that applicants filing human drug, biological, and device product submissions certify compliance with all applicable requirements of section 402(j) of the Public Health Service Act (“PHS Act”).  FDAAA requires that certifications be submitted to the U.S. Food and Drug Administration (“FDA” or “the agency”) beginning no later than December 26, 2007.  For the Center for Devices and Radiological Health (“CDRH”), certifications must accompany premarket approval (“PMA”) applications, humanitarian device exemption (“HDE”) applications, and premarket notifications (“510(k)”).  The certification form can be viewed at www.fda.gov/opacom/morechoices/fdaforms/FDA-3674.pdf.  Additional information is available at www.fda.gov/cdrh/news/121307.html.

FDA Petitioned to Require Additional Information on DTC Device Ads.  Consumers Union, a consumer advocacy group, recently sent a petition to FDA requesting that the agency require all direct-to-consumer (“DTC”) advertisements for implantable medical devices to warn consumers of possible failures or infections that may occur once the devices are implanted.  This petition comes in response to a recent spike in advertisements for implantable devices, most of which lack basic information about the possibility of severe or fatal side effects.  FDA was recently granted increased authority to pre-review such advertisements and require specific disclosures by the Food and Drug Administration Amendments Act of 2007 (“FDAAA”).  Additional information is available at www.fdanews.com. 

Growing Orthopedic Implant Market in India.  India is positioned to become the largest market for knee and hip implants over the upcoming five years; the Indian market is growing at a rate of over 30% annually.  The total number of joint replacements in India is currently estimated to be around 40,000–50,000 and is doubling every year.  In particular, knee replacement surgeries are growing faster than any other category, due in part to the availability of gender-specific devices developed specifically for the Asian population.  It is estimated that two out of every ten people in India over 65 years of age currently have osteoarthritic knees. Additional information is available at http://www.devicelink.com/newsedge. 

FDA Releases New Guidance Document: Interactive Review for Medical
Device Submissions: 501(k)s, Original PMAs, PMA Supplements, Original
BLAs, and BLA Supplements. On December 28, 2007, the FDA released a new
guidance document outlining the roles of both FDA and industry in a new
interactive review process designed to help FDA meet new performance
goals set in response to the Food and Drug Administration Amendments Act
of 2007 ("FDAAA"). The interactive review process is intended to
facilitate timely and efficient review of premarket submissions and
contemplates increased informal interaction between FDA and applicants
during the review process. Specifically, the interactive review process
is designed to improve interaction between FDA and applicants, prevent
unnecessary delays, ensure that FDA's concerns are clearly communicated
to the applicant, minimize the number of review cycles and questions,
and to ensure timely responses from applicants. The guidance document
can be accessed at http://www.fda.gov/cdrh/ode/guidance/1655.pdf.

Representatives Concerned About Medicare Cuts. A bipartisan group of 69
representatives has written to House Speaker Nancy Pelosi to express
concerns regarding additional cuts to imaging services provided by
Medicare. The cuts are being considered in the House version of the
Children's Health and Medicare Protection Act. The group also expressed
support for the Access to Medicare Imaging Act of 2007, which seeks to
impose a two-year moratorium on the Deficit Reduction Act, which has cut
medical imaging by $13 billion this year. Additional information
available at www.fdanews.com .

Voluven Receives FDA Approval. On December 27, 2007, the U.S. Food and
Drug Administration approved Fresenius Kabi's Voluven for treating loss
of blood volume, which can occur during surgery. Voluven, which
contains a synthetic starch that does not dissolve in water, is made by
linking individual starch molecules together and combining them with a
salt solution. The product expands the volume of blood plasma, thereby
drawing fluid into the capillaries. Clinical trials demonstrate that
Voluven is as safe and effective as other blood volume expanders for
adults, newborns, and infants. Additional information is available at
www.fda.gov/bbs/topics/NEWS/2007/NEW01765.html.

Device Firms Advertise Directly to Consumers.  Medical device manufacturers are increasingly advertising directly to consumers, rather than physicians, through television commercials for their products.  But, some physicians are skeptical about the information presented in these ads.  Specifically, physicians are concerned that the complex safety and adverse event information for these devices cannot adequately be conveyed to lay consumers in a short television commercial.  Device manufacturers are cautioned not to alienate physicians in the race to extend marketing to the consumer.  If firms target consumers too early in the marketing process, physicians may not be adequately informed or educated about the product to answer patient questions appropriately.  And many physicians are concerned that patients who request a product on the basis of short, television commercials do not always understand what they are asking for.  Although television ads may serve as a vehicle for patient education when done properly, device firms should be sure not to imply that the product has no potential complications.  The U.S. Food and Drug Administration (“FDA”) expects these advertisements to present a balanced view of the product’s risks and benefits, but notes that the requirements for risk statements in device ads are minimal when compared with those for drugs.  Congress recently gave FDA the authority to fine drug companies based on their false or misleading ads—the agency is expected to tighten the enforcement of device ads as well.  Meanwhile, industry has requested guidance on preparing short direct-to-consumer advertisements.  Additional information is available at www.thegraysheet.com (paid subscription service).

Barriers to Adoption Prevent Innovative Technologies From Coming to Market.  Although device firms have developed technology to monitor a patient’s physiological condition, as well as that of the device, from many locations, the market is generally limited due to a reluctance among companies to advance interoperability.  Industry insiders believe that all-around barriers to adoption, rather than a lack of technology, is holding back patient care.  In particular, insiders are concerned that many manufacturers design products that will not communicate with complementary products by other manufacturers, limiting the value that each individual device to the patient.  One key issue appears to be the lack of incentive to device firms to push interoperability as quickly as technology would allow; however, some are looking for a solution.  For example, third-party software programs that act as mediators between disparate devices, allowing them to communicate through a central server, have recently appeared on the market to address providers’ interconnectivity problems.  Insiders agree that health care providers have an important role to play in pushing for better interoperability of medical devices.  Along those lines, device firms can incorporate standard wireless network connections into their devices as a first step.  Additional information is available at www.thegraysheet.com (paid subscription service). 

FDA Expert:  User Fees are Destructive.  According to Peter Barton Hutt, a senior counsel at Covington & Burling in Washington, D.C., Food and Drug Administration (“FDA”) user fees are destructive to the agency’s mission and should be discontinued.  Hutt recently presented a report to FDA that the agency is not positioned to meet its current or emerging regulatory responsibilities, calling for more funding and better trained staff.  According to Hutt, because Congress is required to fund cost-of-living increases to premarket review functions to trigger FDA user fee collection, but no similar increase is required for non-review functions, Congress has neglected to provide sufficient funds to non-user fee activities.  As such, the non-premarket review “core” functions of the FDA lost approximately $250 million in funding between 2002 and 2005.  Hutt concludes that as a result of user fees, FDA’s core mission is systematically being dismantled.  Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Risk Committee to Assess Publication of Product Safety Information.  A new risk communication advisory committee, scheduled to meet for the first time in early 2008, is tasked with helping the Food and Drug Administration (“FDA”) to systematically analyze how the public receives and interprets product safety information.  Although historically such information was released only after a time-consuming evaluation, today’s patients and doctors want this information earlier than ever before.  Thus, FDA is caught making safety judgments based on incomplete information—the agency does not want to wait so long that patients are unnecessarily harmed by an unsafe product, but does not want to remove a beneficial product from the market based on preliminary data.  Experts caution that device safety information must be carefully scrutinized before informing the public; while a drug can easily be removed from the market, implantable devices pose a more difficult question.  Additional information is available at www.thegraysheet.com (paid subscription service).

Supreme Court Likely to Find in Favor of PMA Preemption. On December 4,
2007, the U.S. Supreme Court heard oral arguments in the case of Riegel
v. Medtronic. At issue in the case is whether section 360k(a) of the
Federal Food, Drug, and Cosmetic Act ("FDC Act") supports preemption of
state-law claims seeking damages for injuries caused by medical devices
that have received premarket approval ("PMA") from the U.S. Food and
Drug Administration ("FDA"). Court observers note that a majority of
Supreme Court justices appear to support some form of federal PMA
preemption; however, it is likely that the decision will carve out some
caveats in which certain types of claims are preempted and others are
not. The case looks very good for Medtronic, who argued that premarket
approval of a medical device and its labeling protects companies from
liability for patient injury in state court. Legal experts agree that
the Court will likely find in Medtronic's favor; the question is how
broadly or narrowly the Court will define PMA preemption. Additional
information is available at www.thegraysheet.com (paid subscription service).

Ad Hoc Panel Finds FDA Scientific Expertise Inadequate to Handle New
Device Technology. According to a November 29, 2007, report issued by
the Subcommittee on Science and Technology, an ad hoc panel of FDA's
Science Board, the Center for Devices and Radiological Health ("CDRH")
is ill equipped to understand the science underlying many cutting-edge
device technologies. Specifically, the report finds that CDRH needs
more resources and personnel to improve its scientific understanding of
nanotechnology, wireless devices, robotics, and other new technologies.
Subcommittee members cite the accumulating unfunded statutory
responsibilities placed on the agency, the rapid advance of scientific
technologies, and the complexity of new products, among other issues, as
contributing to the agency's precarious position. The report also
prioritizes 15 areas of new technology in which CDRH expertise is
lagging, including artificial organs, genomics and proteomics, home- and
self-care devices, and telemedicine. Without additional CDRH personnel
to handle the scientific needs in the premarket review process of
emerging technologies, the panel concluded that such technologies may be
unable to reach their full potential. Additional information available
at www.thegraysheet.com (paid subscription service).

FDA-Duke Clinical Trial Initiative Focuses on IRB Reform. The new
public/private partnership between FDA and Duke University intended to
modernize clinical trials has named institutional review board ("IRB")
reform as one of its first goals. The partnership plans to streamline
and standardize the process of obtaining IRB approval for clinical
research so that larger studies can be completed more quickly and less
expensively. The partnership believes that under the current system,
IRBs are expected to do too much, resulting in unnecessary delays to
clinical research for devices and drugs. The IRB regulations were
written in the early 1970s, at a time when most clinical trials were
conducted at a single study site. The partnership intends to update
these outdated regulations to better define the role of IRBs and devise
ways to expedite the IRB approval process. Additional information is
available at www.thegraysheet.com (paid subscription service).

New FDA Guidance Document: Consensus Standards. The FDA recently
published a new guidance document for medical device manufacturers that
rely on recognized consensus standards in their premarket submissions.
Conformity to consensus standards may reduce the amount of documentation
and time necessary to complete the premarket review process. A current
list of FDA recognized standards can be found at
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. The new guidance document, "Recognition and Use of Consensus
Standards; Guidance for Industry and FDA Staff," can be viewed at
www.fda.gov/cdrh/osel/guidance/321.pdf. Additional
information is available at www.fdanews.com.

Proposed eMDR Rule Due in February. The FDA expects to release a new
proposed rule in February 2008 to make electronic medical device
reporting ("eMDR") mandatory. The proposed rule is expected to give
companies one year from issuance of the final rule to begin using eMDR.
The agency does not expect medical device firms to experience difficulty
making the transition to an electronic reporting form. Additional
information is available at www.fdanews.com.