Hoping to Relax Regulatory Burdens, Medical Device Manufacturers Gain Clout on the Hill

Medical device manufacturers, including their industry representatives, are gaining significant influence on Capitol Hill, reports The Star Tribune.

The article notes that the industry, led by industry association AdvaMed, has been working hard with legislators and lobbyists alike to advance initiatives that would reduce their regulatory burdens.

Among the recent political developments that are favorable to the industry:

• A bill to change the US Food and Drug Administration's mission statement to include job creation as a core tenet
• A bill to loosen conflict of interest rules for advisory committee members
• Efforts to discredit a recent report by the Institute of Medicine
• A bill to disallow states from requiring duplicate inspections of FDA-inspected plants
• Efforts to stall an International Uniform Device code (IUD)
• A bill to require FDA to modify the de novo medical device application process to allow new products to be evaluated directly

While some patient safety advocates are displeased at the recent events, Dr. Jeffery Shuren, director of the Center for Devices and Radiological Health at FDA, says that the agency is firmly committed to making sure that they focus on safety as much as they do on expeditious approvals.

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Star Tribute - Medical device makers gain political momentum