• On 22 January 2009, legislation unveiled the Physician Payment Sunshine Act of 2009 (S. 301) (http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:s301is.txt.pdf). The bill, if passed, would also require drug and medical device manufacturers to publish online for public viewing all gifts to physicians exceeding $100 in a year. Manufacturers failing to comply could be fined up to $1 million.
  • On 28 January 2009, Representatives John Dingell, Frank Pallone, Jr., and Bart Stupak introduced the Food and Drug Administration Globalization Act of 2009 (H.R. 759) available at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h759ih.txt.pdf. The bill provides funding to FDA to significantly increase inspections of food facilities and improve outdated information systems; requires food producers to have preventive food safety plans in place and subjects the plans to FDA inspection; requires food imports to meet all US standards; closes the loopholes in FDA’s ability to trace the source of contaminated products; imposes stiff penalties on companies that violate safety standards; requires parity between foreign and domestic drug and device facility inspections; increases the number of pre-approval drug inspections; prohibits the entry of drugs lacking documentation of safety into the US; requires manufacturers to ensure the safety of their supply chain; grants FDA authority to mandate recalls of unsafe drugs; and creates a dedicated foreign inspectorate to increase FDA’s ability to monitor foreign facilities producing food, drugs, devices, and cosmetics.
  • On 11 February 2009, The House passed the National Nanotechnology Initiative Amendments Act of 2009 (H.R. 554). H.R. 554 makes changes to various aspects of the planning and implementation of the 2001 National Nanotechnology Initiative (NNI). The bill strengthens the environmental, health and safety research component of the NNI and increases emphasis on technology transfer and commercialization of research results from the program. The bill also requires NNI to develop a strategic plan within twelve months of enactment with detailed objectives and funding targets to guide nanotechnology initiatives. The plan must be updated every three years thereafter.