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Industry Appeals for Lame-Duck Legislation
Gollaher |
As the 2006 midterm elections recede into the rearview mirror, U.S. lawmakers have just a few weeks left to wrap up the work of the 109th Congress before departing for the holidays—and before the Democratic Party officially takes control of both chambers of Congress in January 2007. The lame-duck environment could leave many important pieces of healthcare-related legislation in limbo. If Congress does not take them up before the end of the year, they will have to be reintroduced in the next Congress.
One issue that has attracted the attention of a wide range of industry organizations is reauthorization of the federal research and development tax credit, which expired on December 31, 2005. According to proponents, the credit provides companies with an important incentive to make high-risk investments, leading to the development of innovative life saving therapies and medical technologies, thus stimulating job creation and economic growth.
"The uncertainty surrounding the future of the credit and the unpredictability of year-to-year extensions make long-term planning very difficult," said David L. Gollaher, PhD, president and chief executive officer of the California Healthcare Institute (La Jolla, CA), a nonprofit public policy research organization for California's biomedical R&D industry. "It is imperative that Congress enact a permanent R&D credit that will provide companies the appropriate incentives to allow them to continue their operations in the U.S. at a time when foreign countries are aggressively recruiting high-tech industries to move offshore." [ More ]
Endotec to Challenge FDA Injunction
Pappas |
Last month, orthopedics manufacturer Endotec Inc. (Orlando, FL) announced plans to countersue FDA in response to the agency's allegations that the company illegally distributed medical devices without premarket approval (PMA) or a clinical study. The longstanding dispute between FDA and Endotec revolves around the company's Buechel-Pappas total ankle replacement system, which the company maintains is a custom device exempt from PMA requirements.
However, the agency says that the ankle replacement implant does not meet the criteria of a custom device. And now the agency is seeking a permanent injunction against Endotec, which it says has distributed the ankle replacement system since March 2002 in spite of FDA warnings that its actions are illegal.
Endotec president Michael Pappas, PhD, said that FDA's complaint "provides insufficient information and is so vague that it is difficult to formulate a precise response." Nevertheless, he said, "Endotec is pleased that FDA took this action because it may result in a reasonable interpretation of the clauses providing these exemptions. Although these clauses have been in place for 30 years, FDA has yet to publish—as is customary—guidelines on their meaning. Perhaps now the court will help establish such guidelines. Endotec feels that it clearly is within the requirements of the law on the custom devices it manufactures." [ More ]
Imaging Takes a Hit under New Reimbursement Rules
Trysla |
Earlier this month, the Centers for Medicare and Medicaid Services (CMS; Baltimore) announced new reimbursement rules for outpatient services and physician payments under the provisions of the Deficit Reduction Act of 2005. CMS officials say that expanded coverage under the new rules will promote preventive care and increase patient access to some of the latest diagnostic and treatment technologies. Yet, under the new physician payment rule, medical imaging—often a key component of early diagnosis and treatment—will take a significant hit. Full payment would be provided for the first procedure, but additional imaging procedures done on adjoining body parts during the same session will be subject to a 25% reimbursement reduction.
In response, the Access to Medical Imaging Coalition (AMIC; Washington, DC) is petitioning Congress to pass the Access to Medicare Imaging Act. The act would delay implementation of the cuts in imaging reimbursement for two years while the Government Accountability Office studies their potential impact. Tim Trysla, executive director of AMIC and a former CMS policy analyst, said, "There's no logic, no reason, and no evaluation . . . of the massive reductions in payment for imaging services ranging from cancer care to heart treatments." [ More ]
Drug-Eluting Stent Safety Issues Dominate TCT Meeting
Serruys |
In September, clinical presentations at the 2006 World Congress of Cardiology, in Barcelona, Spain, cast a pall over the interventional cardiology sector by suggesting that there is a significant risk of late-term thrombosis associated with the use of drug-eluting stents in coronary angioplasty.
With those somber presentations freshly in mind, it's little wonder that discussions surrounding the safety of drug-eluting stents dominated the annual Transcatheter Cardiovascular Therapeutics (TCT) conference, held last month in Washington, DC. And it's similarly understandable why many cardiologists, medtech manufacturers, and industry analysts expressed relief that studies presented at TCT generally showed no increased risk of thrombosis and resulting myocardial infarction or death with drug-eluting stents when compared with bare-metal stents. Yet, the issue of drug-eluting stent safety is far from resolved, as clinicians and researchers point to different criteria and different patient groups that have been used to define stent thrombosis in many of the studies presented to date. During TCT, a new definition for stent thrombosis was presented. Designed to eliminate the variability of criteria used in clinical trials of drug-eluting stents, the definition was developed by the Academic Research Consortium (ARC), whose members include academic institutions, clinical centers, stent manufacturers, and FDA.
"The definitions developed by ARC are important because they seek to standardize how we view an event like thrombosis across all clinical studies," said TCT presenter Patrick Serruys, MD, PhD, chief interventional cardiologist at the Thorax Center of Erasmus University (Rotterdam, The Netherlands). "Without a common language, ambiguity arises, and that is not helpful for physicians or the patients they treat. With these standardized definitions, we succeed in creating a foundation for clinical advancement of interventional cardiology." [ More ]
FDA Cites Improvement in Meeting Performance Goals
In its report for fiscal year 2005, the Office of Device Evaluation (ODE) in FDA's Center for Devices and Radiological Health (Rockville, MD) says it is meeting—and in some cases exceeding—nearly all of the performance goals set by the Medical Device User Fee and Modernization Act of 2002. During the 12-month period covered by the report, ODE received 8714 major submissions, compared to 8536 in fiscal 2004, a year-to-year increase of 2.04%. ODE completed work on 8272 submissions, down 3.51% from the 8573 submissions completed the previous year.
In its report, ODE compared performance data on premarket approval (PMA) applications from fiscal 2004 and fiscal 2003, because some fiscal 2005 data are still outstanding. For 2004, the average total elapsed time for clearance of original PMA applications was 290 days, compared with an average of 357 days the previous year. Average total FDA review time remained constant at 271 days in each year. For clearance of premarket notification (510(k)) applications, the average total elapsed time in fiscal 2005 was 69 days, compared with 92 days in fiscal 2004. Average total FDA review time on
510(k)s was 49 days in fiscal 2005, compared with 64 days the prior year.
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Smith & Nephew, Biomet Acknowledge Merger Talk
Hann
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The orthopedics sector may be headed for further consolidation. Earlier this month, Biomet Inc. (Warsaw, IN) acknowledged discussions with Smith & Nephew plc (London) concerning a possible merger. As industry talk of a potential deal began to heat up, however, both companies issued statements that seemed to throw cold water on any such speculation—at least in the near term.
Biomet's interim president and CEO, Daniel P. Hann, said that the company "has not made a determination that it is in its best interests . . . to engage in a transaction with any third party." Despite such statements, confirmation of a merger would come as little surprise to most industry analysts. Last April, following the sudden resignation of its long-time president and CEO, Dane Miller, Biomet announced that it had engaged the services of Morgan Stanley & Co. (New York City) to explore strategic alternatives focused on enhancing shareholder value. [
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