Hot Docs: Gaps in Medical Device Regulation, Corporations and Tax Havens

Today's selection of timely reports.

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FDA Hit on Medical Device Testing: Medical devices such as artificial heart valves and hips are being allowed into the marketplace without undergoing the government's most stringent review process, according to a report by the Government Accountability Office. The report, "Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved Through the Most Stringent Premarket Review Process," finds that "a significant number" of the class III devices, "including device types that FDA has identified as implantable; life sustaining; or posing a significant risk to the health, safety or welfare of a patient, still enter the market through a less stringent" process. The report concludes that "given that more than three decades have passed since Congress envisioned that all class III devices would eventually be required to undergo premarket review through the more stringent . . . process, it is imperative that FDA take immediate steps to address the remaining class III device types that may still enter the market through the less stringent . . . process."

Top U.S. Companies Have Tax Haven Subsidiaries: Dozens of the nation's largest corporations have subsidiaries in countries listed as either tax havens or financial privacy jurisdictions, the Government Accountability Office finds. According to the report, "International Taxation: Large U.S. Corporations and Federal Contractors With Subsidiaries in Jurisdictions Listed as Tax Havens or Financial Privacy Jurisdictions," 83 of the largest publicly traded companies were in such locations in 2007, and 74 of those companies had federal contracts that ranged from $12,000 to over $23 billion. The report also says that four federal contractors had more than 50 percent of their foreign subsidiaries in such locations and that three of those four had all of their foreign subsidiaries in such locations. The GAO report acknowledges that the "existence of a subsidiary in a jurisdiction listed as a tax haven or financial privacy jurisdiction does not signify that a corporation or contract established that subsidiary for the purpose of reducing its tax burden."

Bush Administration Antir-Regulatory Policies Harmed Nation: The Bush administration spent eight years dismantling sensible government regulations, to the detriment of the economy, the environment, and the public, a new report concludes. The report, "The Bush Legacy: An Assault on Public Protection," says that the "Wall Street financial collapse may have been far smaller if the Bush administration and previous administrations had honored their promises to strictly enforce existing regulations and if they had given government regulators the flexibility needed to oversee new and complex financial instruments such as derivatives and credit default swaps." The report by the nonprofit OMB Watch also notes that the Bush administration packed regulatory agencies with industry insiders, had an open-door policy for big-donor corporations, and hamstrung safety regulators. OMB Watch Executive Director Gary Bass said the administration "worked hard to weaken sensible safeguards across the board, endangering our environment, stripping away public health and safety protections, and stymieing government's ability to respond to new, emerging hazards."