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Medtronic Pushes for Expansion of 'Sunshine Act'

Feb 27, 2008 | Parker Waichman Alonso LLP

Medical device maker Medtronic Inc. said on Tuesday that a proposed bill aimed at curbing inappropriate relationships between companies and physicians should require all device makers to be included, not just big ones.  The proposed "Sunshine Act" was introduced earlier this year by Senators Chuck Grassley and Herb Kohl and would require companies to publicly disclose—via the Internet—certain payments made to physicians for help with product development, research, and training.  Currently, the bill excludes companies with an annual revenue of less than $100 million as well as physician-owned companies, which Medtronic claims accounts for 75 percent of the companies in the medical device industry.  Medtronic said "a level playing field for all companies is appropriate and that these entities should operate under the same disclosure requirements, recognizing that transparency can help alleviate any real or perceived conflicts of interest with these types of companies as well."

Recently, researchers from the University of California, San Francisco (UCSF) argued that medical devices are not subject to the same rigorous review process as pharmaceuticals and this must change.  The team also found that once a device receives Food and Drug Administration (FDA) approval, an independent technology review could help identify which devices are beneficial.  According to the team, this data would improve health professionals' awareness of "the potential promise and pitfalls of new technology.”

The analysis evaluated the federal review process, how devices come to market, how scientific literature reports on clinical trials involving medical devices, and the effectiveness of independent review boards in improving a technology's medical benefit.   Out of thousands of medical technology applications submitted annually to the FDA, less than 100 undergo the scrutiny required for new drugs.  Most new applications are approved through an expedited FDA process that considers new devices similar to those already approved.  Also, the FDA relies on manufacturers and clinical investigators to initiate recalls and failure reports when a technology is not beneficial or is potentially harmful to patients.

The team suggested assessments by objective third parties as well as FDA approval to ensure deficiencies in clinical evidence and patient safety issues that may arise after approval are recognized earlier on.  Independent review organizations provide transparent, objective evaluations, such as the California Technology Assessment Forum (CTAF) which conducts open, public meetings.  Among others, their review board is comprised of experts in medicine, representatives from medical professional societies, technology manufacturers, policy makers, and insurance providers.  The UCSF Division of General Internal Medicine currently subcontracts with CTAF to provide technology assessments.  To be considered in an assessment, CTAF requires information be published or accepted by a peer-reviewed journal, encouraging companies to publicize their trial results.  “CTAF also requires improvements in patient-oriented outcomes, not surrogate markers….we want to see improvements in disease-free survival and patient quality of life, not just a reduction in tumor size," said Tice, attending physician in the Division of General Internal Medicine at UCSF.  The authors suggest independent review boards summarize their findings into uncomplicated take-home messages patients can easily locate.