Congress opposes FDA CBE rule
This article was originally published in The Tan Sheet
In a Jan. 23 letter to FDA, eight leading members of the House and Senate criticize the agency's proposed rule to limit when a manufacturer can revise product labeling without prior FDA approval. "We are concerned that the intent of this proposal is to protect companies in the pharmaceutical and device industry from being held liable for marketing products they know are unsafe," the letter states. The signatories, who include Rep. Henry Waxman, D-Calif., and Sen. Edward Kennedy, D-Mass, request FDA to provide data on labeling revisions. The proposed rule reiterates the agency's position that FDA-approved labeling preempts state tort claims. The issue of preemption is being addressed by the U.S. Supreme Court in several cases, including Wyeth v. Levine...
You may also be interested in...
FDA's proposal to restrict when companies can revise product labeling without first getting agency approval drew a sharp reaction from lawyers involved in product liability litigation
The (virtual) doors closing on the J.P. Morgan Healthcare Conference is the sign for the biopharma industry that the new year has truly started, but before we get too far into 2021, Scrip has taken a look at five of the biggest non-COVID-19 story themes of 2020 in no particular order.
Our graphic tracker of key developments from emergency authorized vaccines, the global roll-out, and late-stage vaccine candidates.