As we previously posted (here, here, and here), the Patient Protection and Affordable Care Act (“PPACA”) contains a provision that requires chain restaurants with at least 20 locations in the United States and vending machine operators who own or operate 20 or more vending machines to post calorie, fat, and other nutritional information of menu items. Learn More
The FDA has recently expressed that it intends to bring more criminal prosecutions for strict liability offenses under the Food, Drug & Cosmetic Act (FDCA) under the “Park” Doctrine. As we previously discussed, the FDCA makes it a criminal misdemeanor to violate the FDCA even if a person had no knowledge of a violation, did not commit fraud, and did not intend to violate the law. This is known as a “strict liability” misdemeanor, as opposed to criminal offenses that require a defendant to knowingly commit an offense. Learn More
On March 24, 2011, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released a Letter to Industry regarding recommendations to improve medical device import entry review processes in an effort to expedite entry of foreign medical devices into the United States. The Letter to Industry states the Agency’s concern with the increasing “number of imported medical devices that do not have sufficient entry data.” The lack of sufficient entry data means more review time for the FDA to make a decision about admissibility at the port of entry. Learn More
In 2008, the U.S. catfish industry convinced Congress to require tougher federal inspections on just one species of fishâ€â€catfishâ€â€by transferring regulation of domestic and imported catfish from the Food & Drug Administration (FDA) to the Department of Agriculture (USDA). The U.S. catfish industry supported these tougher inspections by the USDA not because it supported tougher regulation on catfish, but because it believed they would be a roadblock to imports from Vietnam and other countries. Learn More
On March 22, 2011, the Supreme Court ruled in a unanimous decision that publicly traded drug companies are required to … Learn More
On March 17, 2011, U.S. Senators Amy Klobuchar (D-MN) and Sherrod Brown (D-OH) wrote to Federal Trade Commission (FTC) Chairman Jon Leibowitz urging the Agency to investigate the potentially anti-competitive behavior of KV Pharmaceutical after the price of a pre-term labor prevention drug for expectant mothers drastically increased. Learn More
As we previously reported, with the passage of the Family Smoking Prevention and Tobacco Control Act of 2009, the FDA … Learn More
As we previously reported, on March 10, 2011, the FDA in cooperation with the Department of Justice announced that a consent decree has been filed against McNeil, PPC, a division of Johnson & Johnson, for failing to comply with current good manufacturing practice (“cGMP”) regulations. Learn More
Outside the United States, stem cell research is thriving, in part due to the availability of government funding. As reported here, the stringent requirements for obtaining federal funding for stem cell research in the U.S. may have unintended consequences, such as the migration of research abroad. Learn More
On March 8, 2011, the Senate passed the America Invents Act, which “most notably, includes a provision preventing patents on … Learn More