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Survey: Medtech Companies Meeting Challenge of Ethics Standards
Claude |
Results of a recent survey indicate that while medical device companies are making progress toward compliance with industry standards for sales and marketing ethics, they are also continuing to encounter challenges along the way. The new survey is a follow-up to a 2006 survey among medical device companies that revealed overwhelming acceptance of industry’s Code of Ethics on Interactions with Health Care Professionals. Industry association AdvaMed developed the code in 2003 in order to promote a high standard of ethical conduct by companies in the medical technology industry.
The 2007 survey benchmarks the code’s effect on firms’ internal operations and the challenges that medical device companies face in fully complying with the code's standards. The survey was conducted by PricewaterhouseCoopers LLP (New York City) in conjunction with the law firm of King & Spalding LLP (Washington, DC) and Compliance-Alliance LLC (Arlington, VA). Results of the survey were presented at the Medical Device Regulatory, Reimbursement and Compliance Congress, held on the campus of Harvard University at the end of March. [ More ]
Stents Dominate ACC Meeting
Baim |
Just as stent manufacturers seemed to be regaining their footing following reports late last year that linked drug-eluting versions of the devices to late-term thrombosis, they were hit with another bombshell. This time, the study called into question not only the efficacy of stents, but also the angioplasty procedure itself. The findings of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) clinical study were reported at the recent meeting of the American College of Cardiology (ACC; Washington, DC) in New Orleans.
The study, which followed 2300 coronary artery disease patients with symptoms of chronic angina and evidence of blockage for four years, found no significant difference in the number of deaths and heart attacks among the patients who received medical treatment plus stents, versus those who were treated with drugs alone.
In response to the findings, Donald Baim, chief medical officer at Boston Scientific, asserted that the role of stents is to relieve symptoms rather than to decrease heart attacks or death, and he called the endpoint of the COURAGE study an “unlikely thesis.” He also noted that the study, which began in 2002, used bare-metal rather than drug-eluting stents. [ More ]
Report Cites Barriers for Medtech Firms Seeking Access to Japanese Market
Agress |
Onerous compliance procedures, associated delays, and increased costs are having a chilling effect on the number of U.S. companies submitting products for review to the agency responsible for approval of pharmaceuticals and medical devices in Japan. According to a report prepared by the United States International Trade Commission (ITC; Washington, DC), the average time for getting new medical devices approved in Japan during 2004 was significantly longer than in other markets.
“The ITC report lays out the key problems and difficulties U.S. medical device manufacturers face in getting their products approved for the Japanese market,“ says Philip Agress, vice president for global strategies and analysis at industry association AdvaMed (Washington, DC). “Japan is well aware of the problems—and has been for years. The delays in getting products approved not only adversely affect market access for U.S. manufacturers, but also prevent Japanese patients from gaining access to beneficial healthcare technologies.” [ More ]
OraSure Plans Counseling Service for Rapid HIV Test
Michels |
OraSure Technologies Inc. (Bethlehem, PA) has taken another step toward seeking FDA approval for home use of its OraQuick Advance rapid HIV test. In March, the company announced that it had contracted the Constella Group LLC (Durham, NC) to design a counseling and referral service as an integral component of the consumer version of the test. For the past five years, Constella has operated a nationwide HIV-AIDS clearinghouse call center for the Centers for Disease Control and Prevention (CDC; Atlanta).
“We have initiated design work on a consumer counseling and referral system and are pleased to have Constella on board to complete the process,” said Douglas A. Michels, president and CEO of OraSure. Citing its extensive experience with the CDC HIV-AIDS hotline, Michels said Constella was “ideally suited to help develop a robust, state-of-the-art, and fully compliant consumer counseling and referral system.” [ More ]
Battle for Biosite Reflects Sustained Interest in IVD Market
Blickenstaff |
Beckman Coulter Inc. (Fullerton, CA) and Inverness Medical Innovations Inc. (Waltham, MA) continue to up the ante in their respective bids to acquire Biosite Inc. (San Diego). Late last month, Beckman Coulter entered into a definitive agreement to buy Biosite for $85 a share, or approximately $1.55 billion. The offer was quickly and unanimously endorsed by Biosite’s board, with Biosite chairman and CEO Kim Blickenstaff saying the decision was in the best interest of the company. Yet, only days later, Inverness made an unsolicited bid for Biosite at $90 per share.
While the bid for Biosite continues to grab headlines in the financial press, a wave of recent activities and acquisitions readily attests to even broader interest in the in vitro diagnostics (IVD) market, which is medtech’s largest sector. [ More ]
FDA Proposes Tougher Criteria for Advisory Committee Membership
Thompson |
Late last month, FDA announced new draft guidance that would implement more-stringent criteria for evaluating potential conflicts of interest among members of advisory committees. Under the guidance, advisers who receive money from a drug or device maker would be barred from voting on whether to recommend approval of that company’s products. Advisers receiving more than $50,000 in disqualifying financial interests would be barred from participating in meetings altogether, regardless of the need for that person’s expertise.
“The bottom line is that device companies will be at risk of having their new, sophisticated technologies reviewed by advisory committees that lack the expertise necessary to understand those technologies,” says Bradley Merrill Thompson, a member of the healthcare and life sciences practice of Epstein, Becker & Green (Washington, DC). “Unfortunately, knowledgeable experts are a scarce resource.” [ More ]
Backdated Options Probe Leads to Exit of Biomet Execs
Binder
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Following an internal probe that uncovered significant mismanagement of stock options practices at Biomet Inc. (Warsaw, IN), the company announced the resignation of CFO Gregory Hartman and executive vice president of administration Daniel Hann. The company said that a special committee formed to investigate the matter determined that Hartman and Hann “were or should have been aware of certain accounting and legal ramifications, respectively, of issuing an option with an exercise price lower than the fair market value on the date of issuance.”
Commenting on the departure of Hartman and Hann, Jeffrey R. Binder, president and CEO of Biomet, said, “The transition of senior officers presents a significant challenge for any organization. However, we have a talented executive team in place, and I am highly confident in our ability to move forward successfully.” Binder replaced Hann, who was interim CEO, only weeks before the fallout from the stock options probe.
Biomet is not alone in its stock options problems. According to an Associated Press report, more than 200 companies have disclosed that they are involved in investigations into their stock options practices with the Securities and Exchange Commission, the Department of Justice, or their own internal audits. [ More ]
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IN THIS ISSUE |
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Survey: Medtech Companies Meeting Challenge of Ethics Standards
Stents Dominate ACC Meeting
Report Cites Barriers for Medtech Firms Seeking Access to Japanese Market
OraSure Plans Counseling Service for Rapid HIV Test
Battle for Biosite Reflects Sustained Interest in IVD Market
FDA Proposes Tougher Criteria for Advisory Committee Membership
Backdated Options Probe Leads to Exit of Biomet Execs
INDUSTRY IN BRIEF
CALENDAR
ABOUT MX
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PREVIOUS ISSUES |
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2007
March
February
January
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INDUSTRY IN BRIEF |
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Late last month, Diomed Holdings Inc. (Andover, MA) was awarded $12.46 million in patent-infringement damages from two defendants, AngioDynamics Inc. (Queensbury, NY) and Vascular Solutions Inc. (Minneapolis). Diomed, whose lawsuit focused on technology for the laser treatment of varicose veins, reports that it plans to seek a permanent injunction against both companies. Read more about this case and other industry patent developments in this month’s edition of “IP Watch.” More.
The angel investment market saw steady growth in 2006, with total investment rising 10.8% over 2005 levels to $25.6 billion. During the year, healthcare services and medical devices and equipment accounted for 21% of total angel investment. Furthermore, investors are optimistic about the business climate for 2007 investment—particularly in the medical device industry. More.
In March, Small Bone Innovations Inc. (SBI; New York City), a medical device manufacturer that focuses exclusively on orthopedic care related to small bones and joints, announced seven acquisitions and licensing agreements dedicated to its portfolio of technologies related to the lower limb. More.
Last week, FDA proposed recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act. The agency is currently accepting public comments on the proposal—which has been endorsed by industry associations AdvaMed (Washington, DC) and the Medical Device Manufacturers Association (Washington, DC)—and FDA plans to hold a public meeting on the issue on April 30. For more information, go to www.fda.gov/cdrh/mdufma.
Last week, bipartisan patent reform legislation was introduced in the House and the Senate. The bill, which is similar to bipartisan legislation introduced last year, would establish a first-to-file patent system and limit the situations in which damages may be trebled for willful infringement.
In March, the Medicare Advanced Laboratory Diagnostics Act (H.R. 1321) was introduced in the House of Representatives. The bill’s introduction was applauded by industry association AdvaMed, which says the legislation will reform Medicare policies that currently discourage the development and adoption of new clinical diagnostic laboratory tests. Among the reforms, the bill would establish a demonstration project to evaluate a new Medicare payment system for molecular diagnostic tests. It would also improve current processes for obtaining adequate reimbursement for new clinical diagnostic lab tests, AdvaMed reports.
The Department of Health and Human Services has appointed Robert M. Kolodner, MD, as the permanent head of the Office of the National Coordinator for Health Information Technology. Kolodner has been serving as the office’s interim head since last September.
In March, the Mann Foundation for Biomedical Engineering (Santa Clarita, CA) announced a $100 million gift to endow an Alfred Mann Institute at Purdue University (West Lafayette, IN). The university-based institute is designed to enable the commercialization of biomedical technologies that improve human health. Mann Foundation president and CEO A. Stephen Dahms said the Alfred Mann Institute at Purdue is the third of a minimum of 12 such institutes that the Mann Foundation for Biomedical Engineering plans to create at select research universities by 2012.
FDA has unveiled a new Web page designed to keep the public informed about the status of postapproval patient studies for certain recently approved medical devices. The new page is available here.
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CALENDAR |
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May 1: Houlihan Lokey Healthcare Conference, New York City.
May 1: MassMedic Annual Conference, Boston.
May 16–17: Medtech Investing Conference, Minneapolis.
May 17–18: Medical Device Manufacturers Association Annual Meeting, Washington, DC.
June 6–8: Medical Marketing Association National Conference, San Francisco.
June 7: SoCalBio Investor Conference, Los Angeles.
June 11–14: Medical Design & Manufacturing East, New York City.
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