This article was originally published in The Gray Sheet
Rep. Rosa DeLauro, D-Conn., wants FDA to halt efforts to establish the Reagan-Udall Foundation, a non-profit created by the recently enacted FDA Amendments Act. "The potential for pressure on FDA staff from Reagan-Udall Foundation-endorsed research is enormous," the chair of the House subcommittee overseeing FDA's budget writes in a Nov. 1 letter to Commissioner Andrew von Eschenbach. The foundation, to be funded from donations, patent revenue and FDA's budget, is tasked to work with FDA on its Critical Path initiative and other efforts to speed product development (1"The Gray Sheet" Oct. 8, 2007, p. 9). By law, four members of the yet-unnamed 14-person foundation board have to be from the device, drug, biotech, cosmetic and food industries
You may also be interested in...
DeLauro targets ortho ads: Rep. Rosa DeLauro, D-Conn., says she may introduce a bill banning direct-to-consumer advertising for hip and knee implants for three years post-FDA approval. She has previously sponsored similar, unsuccessful legislation on drugs alone, but at an Oct. 3 speech at George Washington University, she cited a "new concern" with hip and knee ads "giving no indication of the potential complications and side effects from the major surgery they require." DeLauro, chair of the House appropriations panel that oversees FDA's budget, has noted that her own upcoming hip replacement surgery drew her to the issue. Her speech was mainly about a proposal to create a distinct Food Safety Administration and rename the rest of FDA the Federal Drug and Device Administration
Lilly’s CEO indicates that the long-standing IPR debate that has generally divided the developed and developing world is largely a “false narrative.” The executive also called for lowering regulatory barriers in India amid expectations of the potential debut of Zepbound/Mounjaro in the country next year.
A pioneering approval filing for a therapeutic app by Shionogi is set to herald expansion of ADHD therapies beyond the pill in Japan, along with growth in the pediatric segment for the disorder.